Disposable Circumcision Device Manufacturers (2026): An Evidence-Verified Global Supplier Landscape for Distributors

What a supplier search actually returns in 2026

Takeaway: across 69 tracked answers from three AI engines, the names returned most often for circumcision-device sourcing questions are PlastiBell, ShangRing, Cardinal Health and Circumplast — and three of those four are brands or distributors rather than legal manufacturers, which means the default shortlist is a category error before the first email is sent.

VEMERIX runs a standing telemetry export against three answer engines. The circumcision-relevant slice of the latest snapshot, dated 29 August 2026, covers 23 tracked prompts across three engines — 69 answers in total. Read as the latest answer per prompt and model, the brands named most frequently across those prompts are PlastiBell (14 answers), ShangRing (10), Cardinal Health (9), ZSR (7), Circumplast (7), PrePex (6) and Aspen Surgical (4). VEMERIX analysis of the AI-answer export, latest snapshot 29 August 2026. Two caveats belong with that count and are stated here rather than buried: the tally is computed across all 23 tracked prompts, some of which cover endovenous laser and wound-care topics, so names such as AngioDynamics and Biolitec appear in the same tally for unrelated reasons; and an empty tracked-mentions field is not proof that a company went unnamed in the answer body, so counts were computed against both the tracked field and the prose.

Take the top of that list one entry at a time and the confusion becomes concrete.

PlastiBell is a device design and a trade mark, not a company. In the United States it is catalogued by Aspen Surgical, which lists circumcision devices in its labour-and-delivery range ¹⁹. In the FDA registration cohort, Aspen Surgical Products of Caledonia, Michigan appears twice with two different roles: under the bell code FHG it is registered as "Manufacture Medical Device" combined with "Develop Specifications But Do Not Manufacture At This Facility", and under the clamp code HFX it is registered solely as a "Complaint File Establishment per 21 CFR 820.198" ¹. Both facts are true at once. The role depends on the product code, and a buyer who reads only one of them will draw the wrong conclusion in one direction or the other.

ShangRing is a brand attached to a real and identifiable legal manufacturer. Wuhu Snnda Medical Treatment Appliance Technology Co. Ltd. appears in the FDA cohort as "Manufacture Medical Device" under HFX, holds 510(k) K131373 from 25 June 2013 (and an earlier K121789 from 3 August 2012 under a variant spelling of the company name), and states ISO 13485:2016 and MDSAP certification on its own site ^1202122. This is what a resolvable supplier record looks like: one name, one factory, one clearance number, one quality-system claim you can test.

Cardinal Health is a distributor that is also, at specific sites, a manufacturer. Four Cardinal registrations sit in the cohort with three distinct roles: Hazelwood, Missouri is "Develop Specifications But Do Not Manufacture At This Facility" under HFX; Cardinal Health 200 in El Paso, Texas is "Manufacture Medical Device" under the tray code OHG; Waukegan, Illinois is a complaint-file establishment under both HFX and OHG; and the Tijuana site trading as Kenmex Medical Specialties is "Manufacture Medical Device" under HFX ¹. An answer engine that names "Cardinal Health" as a circumcision-device manufacturer is not wrong, but it is not usefully right either. There is no single Cardinal Health entity to contract with for a device file.

Circumplast is the case where the register and the marketing diverge hardest, and it gets its own section below.

PrePex resolves to Circ Medtech, holder of K103695, cleared 10 January 2012 ²³. ZSR resolves to Dongguan ZSR Biomedical Technology Company Limited, which is the largest single presence in the EUDAMED circumcision cohort and is discussed in the European section ²⁴.

There is a structural reason these answers behave this way, and it is visible in the same telemetry. Across the 384 latest answers in the full export — both VEMERIX and the other client programme running on the same infrastructure — 939 distinct source domains were cited, and 85.3% of citations went to .com domains against 3.3% to .gov. VEMERIX analysis of the AI-answer source-domain export, snapshot 29 August 2026. fda.gov was cited in 41 answers, which sounds respectable until you set it against the 63 citations to a single equipment reseller's blog. The engines are reading catalogue pages, distributor listings and marketplace showrooms, because those are the pages that describe products in sourcing language. Registers describe establishments and decisions, in a vocabulary no marketing page uses. The result is an answer that is fluent about products and silent about legal identity.

That is the gap this report fills. FDA maintains the relevant databases publicly and they are free to search ²⁵. The problem is not access. It is that the register answers a question most buyers are not asking, and the buyer's question — who can supply me and stand behind the file? — has to be assembled from three or four registers that were each built for something else.

The five roles behind one product

Takeaway: one disposable circumcision device can involve five legally distinct parties — legal manufacturer, brand owner, clearance holder, listing establishment and certificate holder — and only two of those five carry the obligations a distributor actually needs. Naming the role before naming the company is the whole trick.

Every public record in this space is an answer to a specific legal question. Read it as an answer to a different question and it will mislead you consistently.

The legal manufacturer is the entity whose name and address appear on the label as the manufacturer, and which carries the design, production, post-market surveillance and vigilance obligations. Under Regulation (EU) 2017/745 this is defined at Article 2(30) and carries the Article 10 general obligations; in the US the equivalent obligations sit under 21 CFR Part 820, now amended into the Quality Management System Regulation ^26272829. The full device file, validated sterilisation cycle, biocompatibility dossier and complaint history must be traceable to this party, even if an authorised commercial entity delivers them. If you cannot name the legal manufacturer for a specific SKU and document the seller's authority, you have not yet qualified the supply chain.

The brand owner appears in no register at all. PlastiBell, ShangRing, Circumplast, Unicirc, PrePex and wee BELL are trade marks. A trade mark can be owned by the legal manufacturer, by a specification developer, by a clinician-founder or by a distributor that commissioned the design. There is no public database that maps a device trade mark to its legal manufacturer, and this single absence explains most of the confusion documented above.

The clearance holder is the applicant named on a 510(k). FDA publishes the premarket notification database and downloadable clearance files ³⁰³¹. A clearance is a decision about substantial equivalence for a described device, made on a specific date, in favour of a named applicant. It is not a licence that travels with a product, and it does not automatically transfer when a business changes hands. For the circumcision cohort, the useful discipline is to look at the applicant's address, not just the name: K151095 is filed by an Australian company with a Texas correspondent, for a device marketed by a UK company ¹¹.

The listing establishment is any facility that registers with FDA under 21 CFR Part 807 and lists the devices handled there ³²³³. The register records a declared activity, drawn from a controlled list: manufacture, contract manufacture, contract sterilise, repack or relabel, develop specifications, reprocess single-use devices, export to the United States, or maintain a complaint file. Registration is annual and fee-bearing under MDUFA ³⁴. FDA's own consumer page states the position without hedging: there is no such thing as an FDA-registered or FDA-certified device, and 21 CFR 807.39 provides that registration does not denote approval and that any representation creating an impression of official approval is misleading ⁴⁵. The register is a customs-and-inspection instrument. Treating it as a quality signal inverts its purpose.

The certificate holder is the party named on a notified body certificate under MDR, or on an ISO 13485 certificate issued by an accredited certification body. These are different objects with different scopes. An ISO 13485 certificate attests a quality management system at named sites for a named scope of activity; an MDR certificate attests conformity of specified devices under a specified annex and conformity-assessment route. A supplier that shows you an ISO 13485 certificate has not shown you a CE certificate, and a supplier that shows you a CE certificate for one device family has not shown you one for the SKU you are buying.

Two structural features of this specific device category make the role map harder than usual, and both are worth understanding before reading the FDA data.

The first is the convenience-kit problem. A large share of the US circumcision market is not sold as a device but as a tray: a sterile pack containing a clamp or bell, drapes, gauze, a scalpel and sundries. FDA's 1997 interim regulatory guidance on convenience kits set out the enforcement position for kit assemblers who combine legally marketed devices without changing their intended use ³⁵. The consequence is visible in the product-code table: OHG, "circumcision tray", is classified Class II under 21 CFR 884.4530 but carries a submission type of "Enforcement Discretion" rather than 510(k) ³². Consistent with that, our 510(k) scan returns zero OHG clearances in 175,559 records. VEMERIX analysis of the FDA 510(k) export, snapshot 24 August 2026. The tray business is therefore a registration-and-listing business, not a clearance business — which is precisely why the register fills up with repackers, kit assemblers and contract sterilisers.

The second is the sterilisation split. A single-use sterile device is almost never sterilised by the company whose name is on the box. Ethylene oxide and gamma processing is a specialist industry, and the contractor registers separately for the same product code. STERIS Applied Sterilization Technologies, operating in this cohort under the Isomedix Operations name, is a clear example ³⁶. Twenty rows in our cohort declare contract sterilisation and nothing else; one more combines it with manufacturing ¹. Every one of those rows is a real, inspected, registered facility. None of them can sell you a device.

Put the five roles into a table and the diagnostic question for each becomes obvious.

The rest of this report applies that table to real names.

Who is actually registered with FDA, and as what

Takeaway: 68 establishments, 82 establishment-by-code pairs, and a role distribution in which contract sterilisation outnumbers plain manufacturing — with a ten-company Sialkot cluster, a four-company Tuttlingen cluster and exactly two Chinese establishments in the entire cohort.

The cohort was defined from the data rather than assumed. The FDA classification export was searched for circumcis|foreskin|prepuce, returning six product codes; PRN, a paediatric position holder, was excluded as out of scope ³⁷. The remaining five — HFX, OHG, FHG, FHJ and QQR — all sit under 21 CFR 884.4530, the regulation for obstetric-gynecologic specialised manual instruments, which lists circumcision clamps explicitly ²³⁸. Their submission types are not uniform, and the difference matters:

Product-code attributes from the FDA classification database ^338394041; counts are VEMERIX analysis of the FDA 510(k) export and the FDA registration and listing export, both snapshot 24 August 2026 ³⁰¹. The QQR row is context, not a new finding — the argument is made in full in the earlier VEMERIX report ¹⁶.

The activity map. Across the 88 listing rows, the declared establishment types break down as follows. Twenty rows declare only "Sterilize Medical Device for Another Party (Contract Sterilizer)". Eighteen declare only "Manufacture Medical Device". Ten combine "Repack or Relabel Medical Device" with "Manufacture Medical Device", and a further nine declare repack-or-relabel alone — nineteen rows in which repackaging is the whole or half of the declaration, plus two more rows that fold repackaging into a longer activity string. Eight rows are contract manufacturers. Seven declare "Develop Specifications But Do Not Manufacture At This Facility" and nothing else. Six are complaint-file establishments under 21 CFR 820.198 and nothing else. Two combine US export with manufacturing, and one declares US export alone. One row, at a Medline site in Laredo, combines single-use device reprocessing with repackaging and manufacturing. VEMERIX analysis of the FDA registration and listing export, snapshot 24 August 2026 ¹.

Read that distribution as a buyer. If you draw a candidate at random from this register, the most likely outcome is a sterilisation plant. The second most likely is a repackager. The chance that you have found a facility declaring plain device manufacture is roughly one in five.

The United States: 42 establishments, mostly logistics. The US portion of the cohort is dominated by the tray economy. Sterigenics appears at five site-and-code pairs across Atlanta, Charlotte, Ontario (California) and Grand Prairie; Midwest Sterilization Corporation appears at four across Jackson, Missouri and Laredo, Texas; Isomedix Operations appears at three across El Paso and Sandy, Utah ¹³⁶. Medline Industries appears at six US and Mexican site-and-code pairs spanning contract sterilisation at Waukegan, repack-and-manufacture at Laredo and Waukegan, specification development at Northfield, and manufacturing at Nuevo Laredo. Cardinal Health appears four times, as described above. Medical Action Industries, Busse Hospital Disposables, Centurion Medical Products, DeRoyal, Avid Medical, LSL Healthcare, Resource Optimization & Innovation and Trinity Sterile fill out the kit-assembly and repackaging tier ^42434445.

Only a handful of US entries are unambiguous device manufacturers. Clinical Innovations, LLC of Murray, Utah is registered under HFX as a complaint-file establishment combined with "Manufacture Medical Device", and holds K061539 from 20 September 2007 covering the Gomco circumcision clamp, the Mogen clamp and the Plastibell circumcision device in one submission — a useful reminder that a single clearance can carry three device designs ¹⁴⁶⁴⁷. Allied Medical LLC, E.M. Adams Co. and Vygon MFG declare manufacturing. Sklar Corporation and Sontec Instruments declare repackaging, consistent with an instrument-catalogue business that sources from surgical-instrument makers abroad ⁴⁸⁴⁹. Aesculap, CareFusion 2200 and Teleflex Medical appear as complaint-file or specification-developer entries ⁵⁰⁵¹.

Pakistan: ten establishments, one city. Every Pakistani entry in the cohort is registered against HFX and located in Sialkot, Punjab: Crown Surgical Corp., Dr. Frigz International, Empire Surgical Instruments Company, Glorious Mercantile Corp., Hazel Enterprises, Madina Surgical Works, Mian Shahid Corp., QSA Surgical, Quality Concept and Washington Surgical International ¹⁵². Six declare "Manufacture Medical Device", two declare US export combined with manufacturing, and two are contract manufacturers. This is the reusable stainless-steel Gomco and Mogen clamp trade, and it is a genuine manufacturing cluster — but it is a different product category from the sterile single-use device this report's reader is usually sourcing. A Sialkot clamp maker is a plausible supplier of reusable instruments and an implausible supplier of a sterile, individually packaged, ethylene-oxide-processed disposable.

Germany: four establishments, one valley. Dufner Instrumente in Tuttlingen is registered under FHG as "Manufacture Medical Device"; MEDICON eG, also Tuttlingen, is registered under HFX as "Manufacture Medical Device"; HEBUmedical in Tuttlingen and Kreidler Medizintechnik in nearby Wurmlingen are both registered under HFX as contract manufacturers ^1535455. Medicon also holds K100916 for the Medicon Mogen Clamp, cleared 6 December 2010 ³⁰. Same observation as Sialkot: this is the precision-instrument trade, not the disposable trade.

China: two establishments. In the entire FDA circumcision cohort, China contributes three listing rows across two establishments. Flexicare Medical (Dongguan) Ltd. is registered under HFX as a contract manufacturer — that is, it makes for someone else, and the someone else is not named in the register ¹⁵⁶. Wuhu Snnda is registered under HFX as "Manufacture Medical Device" ¹²⁰. That is the sum total of Chinese presence in the US circumcision establishment register. Set against the size of the Chinese disposable-stapler industry visible in EUDAMED and in the marketplaces, this is the clearest possible statement that the FDA register is not a global manufacturer directory. It is a register of who has business with the US market, under codes that predate the modern device.

The 510(k) record is thin and old. Thirty-one clearances across 49 years. VEMERIX analysis of the FDA 510(k) export, snapshot 24 August 2026 ³⁰. Nine of the 31 were decided from 2010 onwards, and only three since 2020: K212911, Medline's Konig Mogen Clamp, 18 November 2022; K221356, the wee BELL, 2 February 2023; and K251687, Medline's Konig Bell Circumcision Clamp, 25 February 2026 ⁵⁷⁵⁸⁵⁹. The middle of the record is where the innovation sits: K103695 PrePex (2012), K121789 and K131373 ShangRing (2012 and 2013), K142163 RapideClamp from Medicfit Technology Sdn Bhd of Malaysia (20 April 2015), and K151095 Circumplast (18 September 2015) ^2322216011.

Two records in the cohort deserve a warning label, because they demonstrate how product-code assignment can mislead. K911272, coded FHG (bell, circumcision), is an "ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 114705" from Edward Weck, Inc., cleared 2 July 1991. K831229, coded FHJ (shield, circumcision), is "SUPER SNAPS" from Shofu Dental Corp., cleared 9 May 1983. Neither device name describes a circumcision product ³⁰. A product code is an administrative assignment made at the time of a submission, sometimes decades ago, and a code-based cohort will always carry some residue. State the residue rather than quietly dropping it: two of the four non-HFX clearances in this cohort are almost certainly miscodes, which means the effective clearance history of circumcision bells and shields in the US amounts to K770873 (American Hospital Supply, 1977) and K902119 (Kedumin Kits, 1990).

The practical instruction from this section is short. When a counterparty tells you they are "FDA registered", ask for the FEI number and the product code, then run the establishment search yourself for that code ⁶¹⁶². The register will tell you, in FDA's own controlled vocabulary, exactly which of the five roles they occupy. If the answer is "Sterilize Medical Device for Another Party", you are talking to the wrong company — courteously, and through no fault of theirs.

When the register disagrees with the website

Takeaway: in three of the best-known names in this category, the identity presented on the website and the identity carrying the legal obligation are different entities, in different countries, and in one case one of them no longer legally exists.

This is the section that pays for the report. Each case below is a real, checkable conflict, and each is followed by the resolution procedure that surfaced it.

Case one: Circumplast, Emboss Medical and Novadien Healthcare

Emboss Medical Limited's product page states: "Emboss Medical UK manufactures and distributes Circumplast® all over the world." Read 29 August 2026 ¹⁰. The FDA establishment register tells a different story. Emboss Medical Limited, London, appears in our cohort under HFX with exactly two declared activities: "Export Device to the United States But Perform No Other Operation on Device" and "Develop Specifications But Do Not Manufacture At This Facility" ¹. Those two strings are FDA's controlled vocabulary for we ship it and we designed it, and we do not make it here.

The clearance record adds a third party. K151095, "Circumplast Circumcision Device", was cleared on 18 September 2015 to Novadien Healthcare, P.O. Box 7070, Mount Lewis, NSW 2190, Australia, with Emergo Group in Austin, Texas as correspondent and Milad Melhem as applicant contact ¹¹. Meanwhile a separate UK site at novadien.com presents itself as the "sole distributor in the UK" for Circumplast, describes Emboss Medical as the developer, and states that the "Circumplast device is FDA certified in 2015" — a claim that cannot be correct in the terms used, because FDA does not certify devices and the 2015 event was a substantial-equivalence clearance ⁶³⁴⁵.

None of this suggests wrongdoing. It is an ordinary small-company structure: a UK design-and-brand entity, an Australian regulatory holder, a US correspondent and a UK distribution arm sharing a name with the Australian holder. But a distributor who signs with "the manufacturer" here needs to know which of the four they have signed with, because the party that can transfer or extend the 510(k) is in New South Wales, the party that owns the specification is in London, and the party that physically manufactures is named nowhere in either record.

Resolution procedure. Search the 510(k) database for the device trade name; read the applicant block, not just the applicant name; search the establishment register for the company you are negotiating with, by product code; compare the declared activities against the website claim. Ten minutes.

Case two: Well Lead Medical and Langhe Medical

Chinese supplier directories list Well Lead Medical and Jiangxi Langhe Medical as separate manufacturers of circumcision devices, and our own AI telemetry named "Langhe Medical" independently in one answer. They are not separate. Well Lead Medical's own corporate history page records the Jiangxi Langhe acquisition, and Langhe's English about page describes the company as part of the Well Lead group and as the originator of its circumcision-stapler line ¹²⁶⁴. The transaction is also documented in the acquirer's exchange filing of 2 August 2018 ¹³.

The consequence for a buyer is narrow but real. If you have quotes from both entities, you do not have two competing offers. You have one supplier's two sales channels, and the price spread between them is a negotiating artefact rather than a market signal. It also means the quality-system evidence, the certificate scope and the complaint history behind both quotes are, or should be, the same documents.

Resolution procedure. For any Chinese candidate, check the parent company's investor-relations or corporate-history page and, where the parent is listed, the exchange filing archive. Chinese listed companies publish acquisition announcements in full, and they name subsidiaries precisely.

Case three: Unicirc, Kapasa and three legal names

The Unicirc device is presented across its own web estate under at least three legal names. Unicirc Global states the device is CE marked and that its quality system is ISO 13485 certified ⁶⁵. A second site, kapasamed.com, operates as the Kapasa Medizintechnik presence ⁶⁶. Answer engines, in our telemetry, name the manufacturer as "Kapasa Medizintechnik GmbH".

Two commercial databases that republish Austrian Firmenbuch data report KAPASA Medizintechnik GmbH in Liqu., FN 431205a, as deleted on 26 March 2026 following liquidation ¹⁴⁶⁷. They are not the official register. Treat the result as a red flag requiring a paid official extract, not as a definitive legal-status opinion.

What does exist is a live ISO 13485:2016 certificate. Certificate 1039.231206, issued by UL Solutions, names Kapasa Medizintechnik (Pty) Ltd — a South African company — and runs to 5 December 2026 ¹⁵. South Africa's medicines regulator SAHPRA licenses medical device establishments, so a South African manufacturing base is entirely coherent ⁶⁸. The clinical literature on the device is also South African in origin: the published Unicirc field evaluation appeared in Translational Andrology and Urology ⁶⁹.

So the honest statement is this. The Unicirc device appears to be manufactured by a South African company with a current ISO 13485 certificate expiring in December 2026, marketed through a global brand site, and historically associated with an Austrian entity that has been wound up. We could not verify, from any primary source, which legal entity currently appears on the device label, and we could not retrieve a notified body certificate number for the CE claim. Both gaps are stated rather than filled.

Resolution procedure. Take the exact legal name from the certificate, not from the website footer, and search the relevant national commercial register. In the EU this is national — the Austrian register, the German Handelsregister, the Dutch KvK. A dissolved company is a red flag that no amount of ISO 13485 branding on a homepage will surface.

The general rule these three cases share

In each case the failure mode was the same: a trade name was treated as a legal entity. The device brand is the most visible thing in the transaction and the least legally meaningful. The checks are bounded and repeatable, but elapsed time is not evidence and will vary by register access and jurisdiction.

Build this into your qualification form. Ask for the legal manufacturer's registered name in its own language and script, its registration number in its home commercial register, and the name exactly as it appears on the device label. Then check that all three match. When they do not — and in this category they frequently do not — you have found the question you need to ask before you find the problem after launch.

The European Union: five manufacturers, five representatives, one verifiable certificate

Takeaway: the EU disposable-stapler cohort is five named Chinese manufacturers with five named European representatives, all Class IIa, and only one of the five has a certificate you can look up — which makes EUDAMED useful as a shortlist generator and useless as a certificate substitute.

The public EUDAMED device module was scanned line-wise across 2,926,029 records for circumcis|zirkumzision|prepuce|foreskin|phimosis, returning 141 device records. VEMERIX analysis of the EUDAMED device export, snapshot 24 August 2026 ⁶⁷⁰. A device record is a Basic UDI-DI or DI row, not a product; a manufacturer with eight sizes on the market generates eight rows. That is why the counts below are records and not SKUs.

The stapler cohort. Five Chinese legal manufacturers account for 90 of the 141 records, all at risk class IIa, all with status "on the market":

VEMERIX analysis of the EUDAMED device export, snapshot 24 August 2026 ⁶. ZSR's corporate site describes the group and its circumcision anastomat line, read 29 August 2026 ²⁴. Xi'an Kaydee maintains a marketplace showroom for the same device family, read 29 August 2026 ⁷¹. Caretechion GmbH is registered at Niederrheinstrasse 71, Düsseldorf, in the Düsseldorf commercial register under HRB 82833, with a stated business purpose covering consulting and import-export in medical devices ⁷². Llins Service & Consulting GmbH publishes its EU authorised representative service directly ⁷³.

Now the certificate check, which is where the cohort thins out. The public EUDAMED certificate dataset in this snapshot holds 3,937 latest-version rows across 2,799 distinct holders and 49 notified bodies. Searching it for the six cohort manufacturers returns two rows, and both are the same certificate: HZ 2090547-1, notified body SRN 0197, holder SRN CN-MF-000028788 (Changzhou Tongchuang). One row is status issued, dated 10 January 2025; the other is status reissued, dated 9 February 2026 as Rev.1. Both expire 9 January 2030, and both carry latestVersion = True, so certificate-number deduplication is required before counting. VEMERIX analysis of the EUDAMED certificate export, snapshot 24 August 2026 (inner snapshot 25 July 2026) ⁷⁴.

Both certificate rows record an authorised representative SRN of DE-AR-000000001, while Tongchuang's device rows name Shanghai International Holding Corp. GmbH (Europe) as authorised representative ⁶⁷⁴. We could not resolve DE-AR-000000001 to a named actor from the public data available to us, and we do not assert that the two records conflict — a manufacturer may change representative, and the certificate and device records were populated at different times. But it is exactly the kind of discrepancy a buyer should raise: which entity is your current EU authorised representative under Article 11, and does the certificate on file name the same one?

The scope of that one certificate is readable, and it is worth reading. TÜV Rheinland's public register lists test mark 9000012442 for Changzhou Tongchuang, with scope "Regulation (EU) 2017/745 Annex IX Chapter I — Products of class IIa … H020101 — MECHANICAL SKIN STAPLERS — Disposable Skin Staplers — Disposable Circumcision Staplers" ⁷⁷⁵. That is the level of specificity a distributor should be demanding from every candidate: a certificate number, a conformity-assessment route, a class, and a device-nomenclature code narrow enough to cover the actual product. The other four manufacturers in the cohort publish CE and ISO 13485 claims as unnumbered image captions on their own sites. Those claims may be entirely valid. They are simply not verifiable from what is published.

Absence has a defined meaning now, and it is narrower than it used to be. The Commission declared the Actor, UDI/Device and Notified Bodies and Certificates modules functional by decision of 27 November 2025, and Regulation (EU) 2024/1860 set the mechanism by which their use becomes mandatory six months after that notice — that is, 28 May 2026, which is before our snapshot ⁸⁹⁷⁶⁷⁷. So "not in EUDAMED" is no longer explained by "the register is voluntary". Two narrower explanations remain, and both are legitimate:

1. Notified bodies have 18 months from the functionality notice to upload legacy certificates, and are required to upload only the latest relevant certificate. A manufacturer whose MDR certificate was issued before the module opened may simply not have been uploaded yet.
2. Registration attaches to devices placed on the EU market. A manufacturer that does not sell into the EU is correctly, lawfully absent.

That second point applies to our own client, and we publish it rather than omit it: VEMERIX (Weihai Medison Medical Equipment Co., Ltd.) returns zero device records in this EUDAMED snapshot ⁶⁷⁸. The reason is the second one, not the first. That is what the register is supposed to show for a manufacturer whose EU market activity does not require registration, and a reader applying this report's method to VEMERIX should reach the same conclusion they would reach for anyone else: ask for the market-specific evidence rather than inferring from an absence.

The rest of the 141. The non-stapler remainder of the EUDAMED cohort is instructive in its own right, because it shows how many different objects share the word "circumcision":

• Procedure-pack producers. Medica Europe B.V. (NL-PR-000000117) registers circumcision trays and sets at classes I, IIa and IIb. PAUL HARTMANN AG (DE-PR-000019925) registers a "Zirkumzisions-Set" at class III, with one variant flagged as not intended for the EU market. BATIST Medical Productions s.r.o. (CZ-PR-000023497) registers "SET 367A Circumcision Set" at class III. Fuhrmann GmbH registers a "Circumcision-Set" at class IIa. VEMERIX analysis of the EUDAMED device export, snapshot 24 August 2026 ⁶. A procedure pack takes the classification of its highest-class constituent, which is why a tray can be class III while the clamp inside it is class IIa. A buyer sourcing "circumcision kits" for the EU must know which object they are buying, because the conformity route differs completely.
• Reusable-instrument manufacturers. Zepf Medical Instruments GmbH (DE-MF-000005528) registers twelve class I circumcision clamps in named diameters, including Winkelmann and Mogen patterns. SUBAN Kéziműszer of Hungary registers a class I Winkelmann clamp. Surtex Instruments Ltd (GB-MF-000023183) registers eleven class I Gomco and Mogen clamps in brass with chrome plating — and, being a UK manufacturer post-Brexit, does so through a Spanish authorised representative, CMC Medical Devices & Drugs SL ⁶⁷⁹.
• Textile and drape packs. Three Turkish manufacturers — EFAMED, STERAMED and HANEDAN — register class I circumcision drape packs and, in EFAMED's case, "circumcision panties" in three sizes ⁶.
• Kit manufacturers with EU representation. Hubei Lanbin Medical Group appears twice, once as a procedure-pack producer (CN-PR-000054390) and once as a manufacturer (CN-MF-000049717) of a "Male Circumcision Kit" at classes I and IIa, with Share info GmbH as representative. Cobes Industries (Hefei) registers a class I "Minor Surgery and Phimosis Kit Pediatrics" with Emergo Europe B.V. as representative ⁶.

The searches used above are public and free. The device, certificate and actor screens each accept a manufacturer name, an SRN or a Basic UDI-DI ⁷⁰⁷⁴⁸⁰. Notified body identity is verifiable separately through the Commission's notified-body database in the Single Market Compliance Space ⁸¹, and the Medical Device Coordination Group's endorsed guidance is the reference set for how these obligations are interpreted in practice ⁸². If a candidate cannot give you the four identifiers — legal manufacturer SRN, authorised representative SRN, Basic UDI-DI and certificate number — the correct inference is not that they are non-compliant. It is that they cannot yet evidence compliance to you, and that the burden of the next step sits with them, not with you.

The verified manufacturer landscape

Takeaway: the table below is the shortlist skeleton — every name is drawn from a primary register or the company's own page, every role is stated in the register's vocabulary, and the "certificate number published" column is almost uniformly empty, which is itself the finding.

This is not a ranking and it is not a recommendation. It is an evidence inventory. Read each row as what the public record supports about this entity, and treat every blank as a question for the first email rather than as a defect.

Three patterns run through that table and none of them are visible from a search result.

The certificate column is almost empty. Across more than thirty named entities, this bounded public search found one readable MDR certificate number, plus one ISO 13485 certificate hosted as a PDF on a distributor's website in another country. This is not evidence of widespread non-conformity or proof that other certificates do not exist. It shows that public verification is often incomplete. A buyer should therefore request the certificate number and confirm holder, scope, status and site with the issuer.

FDA presence and EU presence barely overlap. Of the thirty-plus entities above, only Medicon appears meaningfully in both the FDA establishment register and the European instrument trade, and none of the five EU stapler manufacturers appears in the FDA circumcision cohort at all. Two registers, two almost disjoint populations, one product family. Any "global manufacturer list" that does not say which register it came from is describing a market that does not exist.

The reusable and disposable trades are different industries. Sialkot, Tuttlingen and the Surtex and Zepf catalogues are stainless-steel clamp manufacturing with a long history and class I self-declaration in Europe. The Chinese stapler cohort is sterile single-use manufacturing at class IIa with notified body involvement. They answer to the same search query and to almost none of the same procurement questions. Decide which one you are buying before you shortlist ⁸⁶.

What the registers cannot tell you

Takeaway: none of these registers records capacity, price, yield, on-time delivery, quality-system maturity or commercial reliability, and a shortlist built only from register evidence will be legally sound and commercially naive.

It is worth being explicit about the boundary of this method, because the failure mode of a good verification habit is over-confidence.

Capacity is invisible. No register in this report records production volume, line count, cleanroom area or annual output. A registered manufacturer may run one shift a week. The only way to establish capacity is an audit, a plant visit, or a validated production record — and the last of those is the reason to ask for lot documentation early ⁸⁷.

Price and cost structure are invisible. Nothing in FDA, EUDAMED or any certificate register touches unit economics. This report deliberately quotes no prices and no landed-cost figures for any manufacturer, because none can be supported from the evidence lanes used.

Quality-system maturity is only partially visible. An ISO 13485 certificate proves that an accredited body found the system conforming at named sites within a stated scope on a stated date. It does not distinguish a system that survives an unannounced audit from one that survives a scheduled one. In the US, the relevant obligations moved from the Quality System Regulation to the Quality Management System Regulation under the February 2024 final rule, which aligns Part 820 with ISO 13485 ²⁹²⁸²⁷. A supplier that cannot discuss that transition in specific terms is telling you something about the depth of its regulatory function.

Post-market performance requires separate work. Adverse-event reports and recalls sit in different FDA databases from the ones used here, and they are the single most under-used source in supplier qualification ⁸⁸⁸⁹. VEMERIX has published a separate evidence map of why sterile devices get recalled and what supplier controls actually prevent it; that analysis is not reproduced here ⁹⁰.

Identity at SKU level requires UDI. The registers in this report resolve companies. Resolving a specific catalogue number to a specific labeller requires the UDI system: 21 CFR Part 830 in the US, with GUDID and its public face AccessGUDID as the lookup ⁹¹⁹²⁹³. For private-label and OEM arrangements this is the field where the true labeller becomes visible, and it is where a "we manufacture it ourselves" claim most often unravels.

And our own client is absent from one of these registers. As stated above, VEMERIX returns zero EUDAMED device records in this snapshot ⁶. We have explained why that is the expected result rather than a gap, but the more important point is methodological: the same test that produced that answer should be applied to every candidate including this one. A report that exempted its sponsor from its own procedure would not be worth reading.

Demand reality check

Takeaway: Medicare Part B circumcision-family services fell 50.9% between 2013 and 2024, but code 54150 combines clamps and other devices and cannot identify disposable staplers. The series is useful as a bounded adult fee-for-service signal, not as a market-size or channel verdict.

Distributors evaluating this category frequently anchor on US demand because US data is the easiest to find. The available US data does not support the anchor.

CMS publishes national utilisation for Medicare Part B by HCPCS code. Filtering the national rows on the circumcision family — 54150, 54161, 54162 and 54163 — gives 89 national rows covering 2013 to 2024. VEMERIX analysis of the CMS Medicare physician and other practitioners data, snapshot 24 August 2026 ¹⁸.

Three observations follow, and the third is the commercially important one.

First, the total fell from 14,052 to 6,904, a decline of 50.9% over eleven years. The 2020 drop is visible and partly pandemic-driven, but the trend runs consistently downward before and after it: 54161, the dominant code, declined every single year from 2013 to 2019 without exception.

Second, the clamp-or-device code is small in this dataset. HCPCS 54150 covers removal of the foreskin using a clamp or device, and in 2024 it accounted for 258 services delivered by 20 providers to 24 beneficiaries, at an average submitted charge of $729.24 and an average Medicare payment of $108.21 ¹⁸. It does not identify which clamp or device was used, so none of those services can be assigned to disposable staplers from this file.

Third — and this is the interpretive point — this dataset is a bounded signal, not a market size. Medicare Part B covers fee-for-service beneficiaries, who are overwhelmingly aged 65 and over. Neonatal circumcision, which is the overwhelming majority of US procedures by volume, is not in this dataset at all, because newborns are not Medicare beneficiaries. What the CMS series does establish is that the adult US fee-for-service segment is small and shrinking, and that a distributor pitching an adult disposable device into US Medicare-reimbursed practice is addressing a few hundred procedures a year.

The volume demand for adult disposable circumcision devices sits elsewhere: in voluntary medical male circumcision programmes across eastern and southern Africa, in urology practice across parts of Asia and the Middle East, and in private-pay adult procedures in markets where the device replaces a longer surgical technique ⁹⁴. WHO's prequalification programme for male circumcision devices exists precisely because programme procurement in those settings needs a device-level assurance mechanism that national regulators alone do not provide ¹⁷. The device-class economics behind that shift are set out in the earlier VEMERIX report and in the wider single-use platform analysis, and are not repeated here ¹⁶⁹⁵.

The sourcing consequence is direct. Pick the destination market before the manufacturer, because the destination determines which register matters, which certificate you need, and which of the entities in the landscape table can legally supply you at all. A supplier that is perfect for a Kenyan programme tender may have no route into Germany, and a class I European clamp manufacturer has nothing to offer a VMMC programme buying disposable staplers by the ten thousand.

The first-contact dossier request

Takeaway: one standardised evidence request, sent to every candidate on the same day, converts a supplier list into a ranked shortlist in about two weeks — and the value is in what each answer proves, not in whether the supplier answers quickly.

Send the same request to everyone. Variation in your questions destroys comparability, and comparability is the entire point. The table below pairs each ask with what a good answer actually establishes, and with the failure mode you should watch for.

Two notes on how to run this.

Give a deadline and hold it. Ten working days is generous for a manufacturer that holds these documents and impossible for one that does not. The response time is itself a data point about the maturity of the regulatory function you are about to depend on.

Verify independently before you evaluate samples. Sample evaluation is expensive in time and attention, and it is the wrong first filter. A device that performs beautifully in a clinic and cannot be lawfully placed on your market is worse than no device, because you will have created internal demand you cannot supply. Run the register checks first; they cost minutes and they eliminate candidates that samples never will.

A shortlist protocol you can run on Monday

Takeaway: six steps, roughly a day of work for a list of twenty candidates, and the output is a shortlist where every remaining name has a verified legal identity and a market-specific route.

Step 1 — Fix the destination market and the configuration. Write down one market and one device configuration: for example, "Germany, sterile single-use disposable circumcision stapler, adult sizes". Do not proceed with "global" or with "circumcision devices". Every subsequent step depends on this line, because the register that matters, the class that applies and the certificate you need are all determined by it. The wound-dressing analogue is instructive: the same physical product can land in different classes in different jurisdictions depending on the claim made for it, and circumcision procedure packs behave the same way ⁹⁶.

Step 2 — Classify every candidate by role before you rank them. For each name on your list, decide from the public record whether it is a legal manufacturer, a brand, a distributor, a kit assembler, a contract steriliser, a specification developer or a complaint-file address. Use the FDA establishment search by product code for US-facing candidates and the EUDAMED actor and device searches for EU-facing ones ⁶¹⁷⁰⁸⁰. Drop every name that cannot be traced to a legal manufacturer or cannot document authority to supply the SKU and its regulatory evidence. A legitimate distributor may remain; an untraceable trading name should not.

Step 3 — Resolve entity identity. For every surviving name, find the legal entity in a commercial register: the national company register in Europe, the exchange filings for listed Chinese companies, the relevant national registry elsewhere. Confirm the entity is active. This is the step that would have caught the dissolved Austrian company, the Australian clearance holder and the Chinese parent-subsidiary relationship described above.

Step 4 — Check market-specific authorisation for the exact configuration. For the EU, that means device record, class, certificate number and notified body. For the US, that means the 510(k) applicant and the establishment role, or an understanding of why the configuration sits under enforcement discretion. For China, the NMPA registration number; for Great Britain, MHRA registration; for South Africa, the SAHPRA establishment licence ⁹⁷⁹⁸⁶⁸. Registration in the manufacturer's home market is necessary context and is not a substitute for authorisation in yours.

Step 5 — Send the standardised dossier request to everyone on the same day. Use the table in the previous section verbatim. Do not customise it per supplier.

Step 6 — Score on evidence completeness, not on enthusiasm. Build a matrix with candidates as rows and the dossier asks as columns, and fill it with three values only: verified, claimed-but-unverified, and absent. Preserve unknowns as unknowns; do not promote a claim to a fact because the salesperson was convincing. Then start conversations with the top of that matrix. The register-based approach used throughout this report generalises to other device families, and the same discipline applied to endovenous laser fibres produced a comparably counter-intuitive result about which component is actually the registered device ⁹⁹.

Frequently asked questions

Who actually manufactures the PlastiBell? PlastiBell is a device design and trade mark rather than a company, and different entities have made and sold devices under that name and in that design over time. In the current FDA circumcision cohort, Aspen Surgical Products of Caledonia, Michigan is registered under the bell code FHG as a manufacturer combined with a specification developer, and lists circumcision devices in its labour-and-delivery catalogue ¹¹⁹. Clinical Innovations, LLC holds K061539, which covers the Plastibell circumcision device alongside the Gomco and Mogen clamps ⁴⁷. If you need the manufacturer of a specific catalogue number, resolve it through UDI rather than through the brand name ⁹³.

Is "FDA registered" the same as FDA approved or cleared? No, and FDA says so directly. Its consumer guidance states that FDA does not register or certify devices, and 21 CFR 807.39 provides that registration does not denote approval and that any representation creating an impression of official approval is misleading ⁴⁵. Establishment registration means a facility declared an activity and paid the annual fee ³²³⁴. Clearance means FDA reviewed a 510(k) and found the device substantially equivalent to a predicate ³⁰.

Why can't I find any FDA clearance for disposable circumcision staplers? The product code that describes them, QQR, exists and requires a 510(k), yet the cohort scan returns zero cleared submissions under it. That finding was published in the earlier VEMERIX report on the disposable circumcision device shift and is treated here as context rather than restated ¹⁶³⁹. The practical implication for a US-facing buyer is unchanged: a stapler quoted for the US market needs a specific, checkable clearance number, and the absence of clearances under the obvious code means you must ask which code and which submission the supplier is relying on.

What does it mean if a manufacturer is not in EUDAMED? Since 28 May 2026, use of the Actor, UDI/Device and Notified Bodies and Certificates modules has been mandatory, so absence carries more weight than it did previously ⁸⁹. It still is not proof of non-compliance. Registration attaches to devices placed on the EU market, so a manufacturer that does not sell into the EU is correctly absent — this is the reason VEMERIX itself returns zero records in our snapshot. Separately, notified bodies have 18 months from the November 2025 functionality notice to upload legacy certificates, and need only upload the latest relevant one, so a valid certificate may not yet be visible ⁶⁷⁶.

A supplier sent me a CE certificate as a PDF. Is that enough? It is a starting point, not a conclusion. Take the certificate number and the notified body number from the PDF and look both up independently: the certificate in the public EUDAMED certificate search, the notified body in the Commission's notified-body database, and where the body maintains its own public register, the certificate there too ⁷⁴⁸¹. The Changzhou Tongchuang example in this report shows what a fully traceable case looks like: EUDAMED shows the certificate number, notified body and validity dates, and TÜV Rheinland's own register shows the scope in device-nomenclature terms ⁷. Also check that the scope covers the device you are buying, not a neighbouring family.

What is the difference between a circumcision device and a circumcision tray, for regulatory purposes? A large one. The device codes — clamp (HFX), bell (FHG), shield (FHJ) and stapler (QQR) — are Class II and require 510(k). The tray code, OHG, is Class II but carries a submission type of enforcement discretion, consistent with FDA's long-standing position on convenience kits assembled from legally marketed devices ³³⁵. In the EU, a procedure pack takes the class of its highest-class constituent, which is why EUDAMED shows circumcision sets from Paul Hartmann and BATIST at class III while the clamps inside comparable packs sit at class I ⁶. Buying "kits" and buying "devices" are different regulatory transactions.

How do I tell a contract manufacturer from a legal manufacturer in the FDA register? Read the establishment-type string, which comes from a controlled vocabulary. "Manufacture Medical Device" is a manufacturer at that facility. "Manufacture Medical Device for Another Party (Contract Manufacturer)" makes product to someone else's specification and cannot give you a device file for it. "Develop Specifications But Do Not Manufacture At This Facility" owns the design but does not make it. "Sterilize Medical Device for Another Party (Contract Sterilizer)" processes other people's product. "Complaint File Establishment per 21 CFR 820.198" is an address where complaint records are held ¹³².

Are Pakistani circumcision-clamp manufacturers a realistic source? For reusable stainless-steel Gomco and Mogen clamps, yes — the ten Sialkot establishments in the FDA cohort are a real and long-established cluster, and several declare plain device manufacture ¹⁵². For sterile single-use disposables they are generally not the right cluster, because the required capability is polymer moulding, cleanroom assembly, validated ethylene-oxide processing and single-use packaging rather than instrument forging and finishing. Match the cluster to the product before you match the company to the quote.

Which Chinese stapler manufacturer should I approach first? This report does not rank suppliers and explicitly makes no comparative quality claim. What the evidence supports is that five Chinese legal manufacturers are registered in EUDAMED for Class IIa disposable circumcision staplers with named European representatives, and that one of them has a publicly verifiable MDR certificate with a readable scope ⁶⁷⁷⁴. If your destination is the EU, verifiable certificate scope is a reasonable first filter. If your destination is elsewhere, that filter is largely irrelevant and you should filter on authorisation in the destination market instead.

Does WHO prequalification replace national registration? No. WHO prequalification of male circumcision devices is a programme-procurement assurance mechanism, used principally by UN agencies and donor-funded programmes; it does not confer national market authorisation anywhere ¹⁷. It is, however, a strong quality signal, and the associated public inspection reports contain manufacturing-site detail that no register publishes — the 2025 report on Wuhu Snnda's facility is an example ¹⁰⁰.

How long does this verification actually take? Start with one candidate and record the actual time in your jurisdiction before estimating the workload for a full list. Register access, language and paid-extract requirements vary. The expensive part is not the checking; it is the months lost when the checking is skipped.

What should I do if a supplier refuses to give a certificate number? Treat it as an answer rather than as an obstacle. Certificate numbers are not commercially sensitive — they are published in EUDAMED and in notified body registers by design. A refusal usually means one of three things: the certificate is held by a different entity, the scope does not cover the quoted device, or the regulatory function is not strong enough to locate the document quickly. All three are things you need to know before, not after, you commit.

Methodology and limitations

Takeaway: six evidence lanes, five of them computed from committed snapshots taken on 24 August 2026, plus primary web verification carried out on 29 August 2026 — with five material limitations that constrain what any of it can be used for.

Cohort definition. FDA product codes were derived rather than assumed. The FDA classification export was searched for circumcis|foreskin|prepuce, returning six codes; PRN, a paediatric position holder, was excluded as out of scope. The cohort is therefore FHG, FHJ, HFX, OHG and QQR, all under 21 CFR 884.4530 ²³⁸.

Datasets and denominators. FDA 510(k): 175,559 records scanned, 31 in cohort (HFX 27, FHG 2, FHJ 2, OHG 0, QQR 0) ³⁰. FDA establishment registration and listing: 419,651 rows scanned, 88 in cohort across 68 distinct establishments and 82 establishment-by-code pairs ¹. EUDAMED public device module: 2,926,029 records scanned line-wise for circumcis|zirkumzision|prepuce|foreskin|phimosis, 141 matching device records ⁶. EUDAMED public certificate search: 3,937 latest-version rows across 2,799 holders and 49 notified bodies, 2 rows matching the cohort and both carrying the same certificate number, requiring deduplication ⁷⁴. CMS Medicare Part B: national rows only, HCPCS 54150/54161/54162/54163, 89 rows covering 2013–2024 ¹⁸. AI-answer telemetry: latest snapshot per prompt and model, 29 August 2026, 23 VEMERIX prompts across three engines. All FDA, EUDAMED and CMS figures are VEMERIX analysis of committed snapshots dated 24 August 2026; the EUDAMED certificate wrapper carries an inner snapshot of 25 July 2026.

Web verification. Every company claim in this report was read on the page cited, on 29 August 2026, and is presented as the company's claim rather than as verified fact unless a register corroborates it. Where a page could not be retrieved from our verification environment, the claim was dropped rather than paraphrased from a secondary source.

Limitation 1 — EUDAMED absence is meaningful but not conclusive. The Actor, UDI/Device and Notified Bodies and Certificates modules became mandatory on 28 May 2026, six months after the Commission's functionality decision of 27 November 2025 — before our snapshot ⁸⁹⁷⁶. Absence is therefore stronger evidence than it was under the voluntary regime. It remains inconclusive for two specific reasons: notified bodies have 18 months from the notice to upload legacy certificates and need only upload the latest relevant one; and registration attaches to devices placed on the EU market, so a manufacturer not selling into the EU is correctly absent. VEMERIX itself returns zero EUDAMED device records in this snapshot, and the second reason is the applicable one.

Limitation 2 — the 510(k) export records clearances, not marketed devices. A clearance from 1977 tells you a decision was made; it does not tell you a product exists. The oldest record in this cohort is K770873 from 11 July 1977 ³⁰. Two of the four non-HFX records in the cohort carry device names that do not describe circumcision products, which is normal product-code residue and is reported above rather than silently removed.

Limitation 3 — FDA registration is self-declared. An establishment entry proves that a facility submitted a registration, declared one or more activities from a controlled list, and paid the current-year fee. It does not prove that the facility is producing, that it has been recently inspected, or that the declared activity is the facility's principal business ³²³⁴.

Limitation 4 — CMS Part B is a bounded US adult signal. It covers Medicare fee-for-service beneficiaries only, excludes neonatal procedures entirely, and must never be read as a market size for the category ¹⁸.

Limitation 5 — no price, capacity, export-volume or quality ranking is supportable. None of the lanes used contains that information. A trade-statistics lane was considered and rejected: in both the object-store artefact and the local copy examined, the reporter and partner country columns were empty for every row, making country attribution impossible. That dead end is recorded here rather than worked around.

One thing we tried and could not complete. We were unable to retrieve, from any primary source, a notified body certificate number for the Unicirc CE claim, or to establish which legal entity currently appears on that device's label. Several company and authorised-representative websites in the EU cohort were also unreachable from our verification environment; where that happened, the entity is named from the register that lists it and no claim is made about what its website says.

Conclusion

The disposable circumcision device market has a supplier-identification problem that is structural rather than accidental. The product family is old enough that its FDA product codes describe reusable clamps and convenience trays, and new enough that the device driving the category's growth has no meaningful presence in the register that most buyers search first. Into that gap flows a search-results layer built from catalogue pages and marketplace listings, which names brands fluently and legal manufacturers almost never.

The registers do contain part of the answer, but they answer a different question than the one buyers ask. FDA's establishment register says who declared what activity: 68 establishments, 20 rows of contract sterilisation, 19 of repackaging, 7 specification developers, 6 complaint-file addresses, and 18 rows of plain manufacturing ¹. EUDAMED says who registered which device for the EU market: 141 records, of which 90 belong to five named Chinese manufacturers of Class IIa staplers; a bounded public certificate search verified one certificate in that cohort ⁶⁷⁴⁷. Neither register says who is good, and absence from the certificate export is not a conformity finding.

What a distributor can do with this is concrete. Fix the destination market first. Classify every candidate by the role the register assigns it before ranking any of them. Resolve the legal entity in a commercial register, because in three of the best-known names in this category the entity on the website and the entity carrying the obligation were different, and in one case the entity most often named no longer exists ^1011121415. Send one standardised evidence request to everyone on the same day. Score on evidence completeness and keep the unknowns visible.

Apply that method to VEMERIX on the same terms as to anyone else. The company is the legal manufacturer behind its own disposable circumcision device line and returns zero EUDAMED device records in this snapshot, for the reason set out above ⁶⁷⁸. The right response to that is not to take our word for it in either direction. It is to send the dossier request in the table above and read what comes back — which is the same instruction this report gives for every other name in it.