Medical Cyanoacrylate Tissue Adhesives (2026): Who Makes Them, How the US, EU and China Class Them, and Where Bulk Supply Comes From

Why a bulk adhesive inquiry returns three supplier populations

When a distributor, hospital group or private-label brand asks for quotes on bulk medical cyanoacrylate, the replies come back with different regulatory vocabularies. One bidder cites a US 510(k) number. Another cites a CE certificate and a European authorised representative. A third cites a Chinese registration number and describes the product as "Class II". A fourth is a national distributor whose brand appears in hospital catalogues and whose name appears on no clearance. The quotes become comparable only once the buyer knows which register each bidder lives in and what that register says about the product.

The registers tell three different stories. The US story is a short list of clearance holders, most of them in Pennsylvania, Georgia and the United Kingdom, plus a wider layer of distributors that label those holders' products. The EU story is a young public database in which two Chinese manufacturers and two American ones sit beside Spanish and Italian brands, all at the same risk class. The Chinese story is a catalogue that treats a skin adhesive as a Class III device and a barrier-only liquid film as a Class II dressing, with domestic registrants on both sides of that line.

This report walks those three registers in the order a cross-border buyer meets them, then puts the three class logics side by side, then explains why the customs heading for sterile tissue adhesives fails as a benchmark for a quote. The evidence is our own analysis of five public datasets, read against the regulatory texts that define the product in each market. Counts are records in public registers, a different thing from sales volumes, capacity or proof that a listed product is on the market today.

Who holds the 36 FDA clearances for topical skin adhesive, and where are they?

The US definition of the product sets the frame for everything else. Under 21 CFR 878.4010(a), a tissue adhesive for the topical approximation of skin is "a device intended for topical closure of surgical incisions, including laparoscopic incisions, and simple traumatic lacerations that have easily approximated skin edges" ⁸. That is the product this report is about. The same regulation, at paragraph (b), defines a tissue adhesive for non-topical use, including embolization of brain arteriovenous malformations and ophthalmic surgery, as a Class III device requiring premarket approval ⁸.

Before 2008: premarket approvals

Topical cyanoacrylates entered the US market through premarket approval, not 510(k). The PMA export lists Dermabond, "a formulation of 2-octyl cyanoacrylate" from Closure Medical Corporation, approved on August 26, 1998 under P960052; Indermil under P010002 on May 22, 2002; and Histoacryl and Histoacryl Blue under P050013 on February 16, 2007, held by Tissue Seal LLC ⁹. The same export carries examples of other internal-use adhesive pathways, which include different chemistries: Trufill n-BCA liquid embolic system (P990040, September 25, 2000, product code KGG), TissuGlu (P130023, February 3, 2015, code PJK) and LiquiFix FIX8 hernia mesh fixation (P220024, June 2, 2023, code PLJ) ⁹¹⁰.

The 2008 reclassification and what the special controls ask for

On May 30, 2008 the FDA published a final rule reclassifying tissue adhesive for the topical approximation of skin into Class II, effective June 30, 2008 ¹¹. The product code for the reclassified device is MPN, reviewed by the General and Plastic Surgery panel (DHT4B). The FDA product code page states that MPN is "Not eligible for third-party review" and is not GMP exempt ¹². Check the current MPN review route when preparing a submission; the present eligibility field alone does not reconstruct how every historical file was reviewed.

The reclassification came with a special controls guidance issued the same day, superseding a 2004 PMA guidance ¹³. The guidance names six risks to health: unintentional bonding or product leaks into eyes, wound dehiscence, adverse tissue reaction and chemical burns, infection, applicator malfunction and delayed polymerization ¹³. It recommends bench testing to ASTM F2255, F2256, F2258 and F2458, a heat-of-polymerization study, degradation analysis by gas or liquid chromatography, subchronic implantation with histopathology, real-time shelf-life monitoring over twelve months covering purity, water content, setting time, viscosity, colour and sterility, a sterility assurance level of one in a million, and prescription labelling ¹³. Biological evaluation is referenced to ISO 10993-1, now in its 2025 edition ¹⁴. A buyer who wants a supplier's test file to be legible against the US special controls can use that list as the table of contents; the supplier qualification guide explains how to read each item ¹⁵.

Two neighbouring codes matter for a buyer reading a quote. A liquid bandage under 21 CFR 880.5090 (product code KMF) is a Class I device, exempt from 510(k) when used solely as a skin protectant; its identification covers a liquid that covers an opening in the skin, and holding skin edges together lies outside it ¹⁶. A tissue adhesive with an adjunct wound closure device, the mesh-and-adhesive systems, has its own Class II regulation at 21 CFR 878.4011 (product code OMD), created on November 10, 2010 ¹⁷. A quote that says "FDA Class I exempt" is describing a KMF product, and a KMF product carries no clearance for approximation of skin edges.

What the 36 clearances look like

We filtered the FDA 510(k) export of August 24, 2026 (175,559 records) to product code MPN and found 36 clearances, decided between December 19, 2008 and September 19, 2025 ¹. Three other records mention cyanoacrylate or skin adhesive in their names but sit under unrelated codes (a 1998 dental cement, a 2006 liquid bandage and a 1981 urine-collector skin adhesive) and were excluded ¹.

The clearances cluster: 19 of 36 were decided in 2013 to 2016. No MPN decision was issued in 2017, 2018, 2019, 2022 or 2023. Five decisions arrived in 2024 and 2025, and three of those came from applicants that had never held an MPN clearance before ¹.

Twenty-five clearances name a US applicant, eight a UK applicant, and Canada, Ireland and India hold one each. Inside the United States, Pennsylvania accounts for 11, Georgia for 5, New Jersey for 3, Ohio and New York for 2 each, and North Carolina and Minnesota for 1 each ¹. No applicant in mainland China, Japan, Korea or continental Europe appears.

The 16 applicant name strings resolve to 14 groups. Four companies account for 23 of 36 clearances: Adhezion Biomedical (nine, 2008 to 2016, SurgiSeal), Advanced Medical Solutions (five across two UK legal names, 2012 to 2020, LiquiBand and Barle), Chemence Medical (five across two Georgia legal names, 2010 to 2021, derma+flex QS and Exofin) and MedLogic Global (four, 2009 to 2011, LiquiBand) ¹. Aesculap holds three (Histoacryl, 2012 to 2014), Ethicon two (Dermabond NX in 2010, Dermabond Advanced in 2015), Optmed two (BondEase, 2015 and 2025) and Okapi Medical dba Resivant Medical two (Cutiva, 2024 and 2025). GluStitch (Canada, 2016), Bergen Medical Products (2016), Meril Endo Surgery (India, March 2024) and Connexicon Medical (Ireland, July 2024) hold one each ¹.

The MPN cohort is broader than cyanoacrylates. BondEase K141157 uses methylidene malonate according to its FDA summary, so the counts below describe topical-adhesive pathway activity, not a chemically confirmed cyanoacrylate supplier census. ¹⁸

Twenty-eight of the 36 were Traditional 510(k)s, five Abbreviated and three Special; all 36 decisions read "Substantially Equivalent" ¹. One detail matters for anyone trying to shortlist by chemistry: none of the 36 device names in the export states whether the product is 2-octyl or n-butyl cyanoacrylate. Chemistry lives on the label and in the 510(k) summary, not in the database listing ¹.

For a US tender, use the 14 historical applicant groups and three PMA lineages as a starting list, allowing for overlap, ownership changes and later decisions. Match each bidder's exact product and intended use to its current authorization. A missing historical applicant name warrants tracing the manufacturer and authorization holder; it is insufficient to judge legality.

Who puts the brand on the vial: the 45 percent without a matched applicant

The 510(k) list answers who is cleared. Whose name is on the box a hospital receives is a separate question, and the FDA device identifier database (GUDID) is the register that answers it, because the entity that submits a device identifier is the labeler, defined in 21 CFR 801.3 as any person who causes a label to be applied to a device, or the label to be replaced or modified, with the intent that the device be commercially distributed ¹⁹. A distributor that relabels a clearance holder's product under its own brand is a labeler. That arrangement is lawful and common, which is why a brand name in a catalogue is silent about who holds the clearance.

We streamed the openFDA UDI export of August 24, 2026 (5,083,948 device records) and kept the 97 records whose product code field contains MPN. They belong to 20 labelers and 52 labeler-brand pairs ². Matching each labeler name against the 510(k) applicant list splits the register in two.

Ten labelers match an MPN applicant or a documented affiliate/brand alias and account for 50 records: Chemence Medical (14), Advanced Medical Solutions Plymouth (13), B. Braun Surgical SA (6, labelling Aesculap-brand Histoacryl, whose 510(k) applicant is Aesculap Inc.), GluStitch (4), Adhezion Biomedical (3), Meril Endo Surgery (3), Ethicon (3), Optmed (2), SkinStitch (1) and Bergen Medical Products (1). Tissue Seal LLC adds three records under its PMA lineage ².

Nine labelers have no matched MPN applicant in this analysis and account for 44 records, 45 percent of the cohort: SourceMark (11, under brands including Exofin, Octylbond and Skin Affix), Henry Schein (7), Cardinal Health (6), Prestige Ameritech (5, PremierPro), Owens & Minor (4, Medichoice), McKesson (3), Covidien LP (3, including LiquiBand Exceed and SwiftSet), Graphic Controls (3, TissueLink) and Medline (2) ². The top five labelers hold 52.6 percent of all MPN records; the top three hold 39.2 percent ².

Two limits apply. Every record reports single-use true, but the sterility column in the openFDA export is blank for all 97 records, so this source leaves sterility untabulated even though the special controls assume it ². And a device record is one identifier rather than a unit sold; GUDID reports identifiers, never volumes.

For a buyer the finding changes one question in the RFQ. When the bidder is a distributor or a private-label brand, the buyer should ask for the identity of the clearance holder whose product is being relabelled and for the current agreement between the two. The record of adverse events and recalls for this product code, mapped in our analysis of the FDA MAUDE and recall record, attaches to the product and its manufacturer, not to the brand on the carton ²⁰.

What the EU register shows so far

Rule 4 for the skin, Rule 8 for the inside

Under the Medical Device Regulation, classification follows Annex VIII and the MDCG 2021-24 guidance. Rule 4 covers non-invasive devices that come into contact with injured skin or mucous membrane: Class I if intended as a mechanical barrier, for compression or for absorption of exudates; Class IIb if principally intended for wounds that have breached the dermis and can only heal by secondary intent; Class IIa if principally intended to manage the micro-environment of injured skin, and Class IIa in all other cases ²¹. The topical records in our EUDAMED cohort all state Class IIa, consistent with the ordinary Rule 4 pathway. Intended purpose, mode of action and any other applicable rule still determine the exact classification.

Internal adhesives fall under Rule 8, which covers implantable and long-term surgically invasive devices and moves them to Class III if they have a biological effect or are wholly or mainly absorbed; the guidance lists "adhesives" among its Class III examples ²¹. The internal/embolic keyword cohort is predominantly Class III; one Class I entry requires verification and is discussed below.

The EUDAMED cohort

We streamed the public EUDAMED device snapshot of August 24, 2026 (2,926,029 records) with a multilingual keyword rule covering cyanoacrylate, tissue adhesive, skin adhesive and their German, French, Spanish and Italian equivalents, plus known brand names. That produced 100 matches, which we sorted by trade name into topical skin adhesives, internal or embolic adhesives, applicators, non-cyanoacrylate latex skin adhesives for appliances, and one oral adhesive ³.

The topical cohort is 44 records, 11 Basic UDI-DIs and six legal manufacturers, all Class IIa and all "on the market": Neo Modulus (Shandong) Medical Sci-Tech, China, 10 records, authorised representative MedPath GmbH; Ethicon LLC, United States, 8 records (Dermabond, Dermabond Advanced, Dermabond Mini, Dermabond Prineo); Zhejiang Perfectseal New Material Technology, China, 7 records, authorised representative Caretechion GmbH; Chemence Medical Inc., United States, 7 records; B. Braun Surgical SA, Spain, 6 records (Histoacryl Flexible); and GEM SRL, Italy, 6 records (Glubran Tiss 2) ³. By registration country the 44 records split China 17, United States 15, Spain 6 and Italy 6.

The internal and embolic cohort is 30 records from three manufacturers, all Class III apart from one Class I Scleroglubran entry: GEM SRL (19 records of Glubran 2 in surgical, radiology and phlebology presentations), FG Grup of Türkiye (9 records of the BIOLAS liquid embolic kit) and Medos International SARL of Switzerland (2 records of Trufill n-BCA, authorised representative DePuy Ireland) ³. The remaining matches are GEM's spray applicators (10, Class IIa), latex-based "Hautkleber" from Manfred Sauer and Ultrana for securing appliances (15, Class I, not cyanoacrylate) and GluStitch's PeriAcryl oral adhesive (1, Class I) ³.

Two things the register shows and a brochure omits

First, Chemence Medical's seven Class IIa records include, beside its own Exofin range, "Histoacryl Octyl B. Braun CE" in 1 ml and 0.5 ml presentations and "Leukoplast Skin Adhesive" in 0.36 ml and 0.7 ml presentations ³. B. Braun Surgical SA is itself the manufacturer of record for Histoacryl Flexible. The register therefore shows a US clearance holder from Georgia as the legal manufacturer behind a B. Braun octyl line and a Leukoplast-branded skin adhesive in Europe. For a private-label buyer, that is the most useful kind of fact a register can give: the name of a company that already manufactures for other people's brands.

Second, two Chinese manufacturers hold Class IIa records with European authorised representatives. Chinese supply, absent from the US MPN list, appears in the EU register at the same class as Ethicon and B. Braun ³. The register records only class, status and names, and this report makes no comparison between the products.

The limit of the snapshot

Mandatory use of EUDAMED's first four modules began on May 28, 2026 under Commission Decision (EU) 2025/2371, with transitional registration deadlines for qualifying previously marketed devices ²². Our snapshot is three months after that date. LiquiBand and Indermil, both long-established European brands, return no record in it, and the legislation and sterile fields are empty for every match ³. Qualifying devices already placed on the market before the mandatory-use date can fall within the November 28, 2026 registration transition. Keyword coverage also limits this extract. Absence therefore needs a product-level check; the extract cannot establish why a particular brand is missing. ²³

How China classes cyanoacrylate: a Class III adhesive code and a Class II dressing code

What the catalogue says

The NMPA Medical Device Classification Catalogue was published by announcement 2017 No. 104 and took effect on August 1, 2018 ⁴. Three entries decide where a liquid wound product sits.

Code 02-13-09, 粘合剂 (adhesives), is defined for "用于手术切口接近皮肤表面边缘的封闭，包括微创介入手术穿刺口的封闭、完全清创后的封闭", closure of surgical incisions at the skin surface, including puncture sites from minimally invasive procedures and wounds after complete debridement. Its listed examples are α-cyanoacrylate isobutyl adhesive, α-cyanoacrylate n-butyl adhesive, 2-octyl cyanoacrylate adhesive and 医用皮肤胶 (medical skin glue). The class is III ⁴.

Code 02-13-10, 粘堵剂 (sealants and occlusion agents), covers surgical sealants and vascular occlusion products and is also Class III ⁴.

Code 14-10-08, 液体、膏状敷料 (liquid and paste dressings), covers solutions or ointments with no pharmacological action and no absorbed ingredient that form a protective layer on a wound surface and act as a physical barrier. For chronic wounds the class is III; for "小创口、擦伤、切割伤等非慢性创面", small cuts, abrasions, incised wounds and other non-chronic wounds, the class is II ⁴.

The line is therefore drawn by claim. Holding skin edges together is an adhesive claim and Class III. Covering a small cut with a film is a dressing claim and Class II. A Chinese registration number tells the buyer which side of that line a product was registered on, and the number can be read without a database.

Reading a Chinese registration number

The prefix shows who approved the product and where it was made. 国械注准 is a national NMPA approval of a domestic device; 国械注进 is a national approval of an imported device; a provincial character followed by 械注准, such as 鲁械注准 (Shandong), 赣械注准 (Jiangxi) or 苏械注准 (Jiangsu), is a provincial approval of a domestic Class II device. The digit that follows the four-digit year is the risk class. In 国械注准20153021282 the year is 2015 and the class digit is 3. In 赣械注准20222140063 the year is 2022 and the class digit is 2 ⁵.

The NMPA UDI cohort

The NMPA registration database has no bulk public export, so we used the register that does: the NMPA UDI full release of September 1, 2026, with 6,139,557 device identifier records, each carrying the registration number the labeler entered ⁵. A broad keyword pass on Chinese device names and descriptions returned 7,184 records, most of them procedure kits whose descriptions mention medical tape. Sorting by device name left 239 records for topical and tissue adhesives, from 22 labelers, citing 32 distinct registration numbers ⁵.

The 32 numbers divide into ten national Class III domestic approvals, ten national Class III import registrations and twelve provincial Class II approvals ⁵. All ten national domestic numbers carry classification code 02-13-09 in their UDI records. Of the twelve provincial Class II numbers, eight carry a 14-10 liquid-dressing code, three carry 02-13-09 and one carries 02-13-00 ⁵.

The national Class III domestic holders are 北京福爱乐科技发展有限公司 (28 records under one number), 北京康派特医疗器械有限公司 (four numbers, 46 records, including a product named 组织粘合胶), 泰科博曼(湖北)医疗技术有限公司 (an α-cyanoacrylate isobutyl adhesive), 广东龙心医疗器械有限公司 (an α-cyanoacrylate n-butyl adhesive), 广州白云医用胶有限公司, 永城市科技试验厂 and 秦皇岛市科峰医疗器械有限公司 ⁵. The ten import numbers belong to B. Braun Surgical SA (three), Ethicon LLC (three), GEM S.R.L., Adhezion Biomedical, Meyer-Haake GmbH and 柴曼医疗有限公司, whose number dates from 2024 ⁵. The twelve provincial numbers come from Jiangxi (four), Jiangsu (three), Shandong (two), Zhejiang, Hunan and Hainan (one each); the largest by record count are a Jiangxi 医用粘合剂 with 23 records and a Jiangxi 生物胶 with 21, both under code 14-10-08 ⁵. Twenty-one of the 32 numbers name cyanoacrylate somewhere in the record, and 30 of 32 report sterile packaging ⁵.

One Zhejiang provincial Class II number under code 14-10-08 belongs to Zhejiang Perfectseal, the same manufacturer that holds Class IIa topical adhesive records in EUDAMED ³⁵. That is the clearest single illustration of the report's point: one company, a Class II liquid-dressing registration at home and a Class IIa skin adhesive registration in Europe, and neither status says anything about the United States.

A data caveat that is also a buying rule

UDI records are entered by labelers. The classification code in a UDI record is what the labeler typed; the certificate may say something else. Three provincial Class II numbers in the cohort carry code 02-13-09, which the catalogue lists as Class III ⁴⁵. The UDI file gives no way to tell whether those are typing errors or something else, so this report flags them and leaves them there. The buying rule that follows is simple: ask for the registration certificate and read the approved scope (适用范围) on it. If the scope is barrier coverage of small wounds, the product was registered as a dressing, whatever the UDI record says. Our earlier article on where the class line falls for wound dressings covers the same boundary from the dressing side ²⁴.

Intended use sets the class in each market

The table says the same thing three ways. For topical approximation of skin edges, the United States assigns Class II with special controls under 21 CFR 878.4010(a) and product code MPN; the ordinary EU Rule 4 case is Class IIa, subject to intended purpose and other applicable rules; China assigns Class III under code 02-13-09 ⁴⁸²¹. For adhesive-plus-mesh systems the United States has a separate Class II code, OMD, while EU and Chinese routes require assessment of the exact combined product ¹⁷²¹. For internal, vascular or embolic adhesives, high-risk pathways to assess include: PMA under 878.4010(b), Rule 8 in the EU, and code 02-13-10 in China ⁴⁸²¹. And each market gives a barrier-only liquid film a lower class, Class I liquid bandage in the United States, Class I under Rule 4 in the EU and Class II under 14-10-08 in China, but none of those lower routes covers holding skin edges together ⁴¹⁶²¹.

The consequence for a quote is that "Class II" is the one phrase that means something different in every market. In the United States it is the class of the skin adhesive itself. In Europe there is no "Class II"; the adhesive is IIa. In the cited Chinese catalogue, Class II is the pathway for the specified non-chronic-wound barrier dressings. Determine a particular Class II product's scope from its certificate, including any applicable classification decision or legacy status. A buyer reading a Class II medical adhesive described as a cyanoacrylate skin adhesive for non-chronic wound closure in single-use packaging, which is how the Medical Adhesive in the VEMERIX Wound & Skin range is described on its product page, should ask the same question of any such product: which catalogue code and which approved scope sit behind the class ²⁵.

What HS 3006.10 measures

The heading combines several sterile medical products

Sterile tissue adhesives have no customs code of their own. They sit inside HS 3006.10, which in the US tariff schedule is a single ten-digit line, 3006.10.01.00: sterile surgical catgut, similar sterile suture materials including sterile absorbable surgical or dental yarns, sterile tissue adhesives for surgical wound closure, sterile laminaria and laminaria tents, sterile absorbable surgical or dental haemostatics and sterile adhesion barriers. The general duty rate is free and the reporting unit is kilograms ²⁶. Nothing in the customs record separates a 0.5 ml adhesive ampoule from a box of braided sutures.

The origin mix of the heading

We extracted every bilateral flow for product 300610 from the CEPII BACI database (HS17, version 202601), 29,953 rows over 2017 to 2024 ⁶. World exports rose from USD 4.38 billion in 2017 to 4.92 billion in 2019 and 5.30 billion in 2023, and were USD 5.16 billion in 2024 ⁶.

In 2024 the United States shipped 26.17 percent of world export value, followed by Mexico (10.07 percent), Austria (9.59), Belgium (9.49) and Germany (9.38); the top five together shipped 64.7 percent. Denmark (5.25), Spain (3.20), Ireland (2.73), the United Kingdom (2.35), the Netherlands (2.06), Israel (1.93) and the Dominican Republic (1.84) follow ⁶. China's share was 0.78 percent, rank 21, at USD 40.2 million; India's was 1.06 percent. China's share has stayed inside a narrow band for eight years: 0.51 percent in 2017, 0.67 in 2018, 0.55 in 2019, 0.57 in 2020, 0.62 in 2021, 0.83 in 2022, 0.78 in 2023 and 0.78 in 2024 ⁶.

The table establishes China's share of the combined customs heading. It provides no defensible estimate of the adhesive share within that total, or of which product family drives each country's value. The 17 Chinese-manufactured records in EUDAMED and the 22 domestic registration numbers in the NMPA cohort cannot be reconciled to adhesive-only trade from this heading ³⁵.

The US import series

US imports under the heading, from the UN Comtrade database, were USD 482.1 million in 2019, 509.4 million in 2020, 655.5 million in 2021, a peak of 712.3 million in 2022, 615.2 million in 2023 and 634.8 million in 2024, the last on 1,339 tonnes ⁷. Denmark supplied 28.93 percent of the 2024 value, Israel 17.74, Ireland 15.24, Austria 8.56, Mexico 6.58, the United Kingdom 6.50, Costa Rica 4.75 and Germany 2.59; China is not among the top ten origins ⁷. In the other direction, the United States exported USD 1.43 billion under the heading in 2024, and China was the largest destination at 25.56 percent, ahead of Belgium (17.14) and Japan (14.54) ⁷.

The unit-value spread

Dividing declared value by net weight for each reporter and flow in 2024 illustrates how poorly the combined heading serves an adhesive RFQ. China's imports came in at USD 702 per kilogram (56.64 percent from the United States) and Germany's at USD 598 (59.51 percent from Austria); US imports averaged USD 474 and US exports USD 354 per kilogram. UK exports averaged USD 152, India's USD 86 and China's USD 44 per kilogram ⁷. The sixteen-fold spread is consistent with differences in product mix, valuation and quantity reporting; these data cannot separate those explanations.

Normalizing a quote without the trade data

The trade heading gives an aggregate origin map for its listed products. Its value is an upper bound on the adhesive subset within that heading, not on the global adhesive market or total wound-closure trade. It gives no benchmark for an adhesive quote, and citing it in a negotiation introduces a number that neither side can defend. What can be normalized comes from the register and the label: the fill volume and applicator format the price is quoted for; the register status in the target market (an MPN number, a Basic UDI-DI with its risk class, a registration number with its class digit and code); the sterilization method and the labelled shelf life; and whether the bidder is the clearance holder or a labeler. Our public price benchmarks for single-use consumables explain why reimbursement schedules and procurement awards, not trade headings, are the public prices worth reading for this class of product ²⁷.

A sourcing decision by market

The registers support a short set of rules, one per market. They are written as evidence requirements a buyer can put into an RFQ on Monday.

United States. Ask for the exact product's K-number or applicable historical PMA lineage and verify current ownership, intended use and model coverage in the FDA record. The historical groups above are a starting point, not a closed list ¹⁹. If the bidder is a distributor or brand owner, ask which holder's clearance covers the product and for the current supply and quality agreement with that holder. Establishment registration applies across device classes and proves no product clearance. A Class I exemption claim needs its specific classification and intended use checked; KMF is the liquid-bandage example ¹⁶.

European Union. Ask for the MDR certificate showing Class IIa under Rule 4, the manufacturer's single registration number and the device's Basic UDI-DI, and check them in EUDAMED ³²¹. Assess the applicable transition period, including the November 2026 device-registration deadline for qualifying existing devices; public absence alone is inconclusive ²². For internal-use products, expect Class III and a different certificate.

China. For a tender that specifies closure of surgical incisions, ask for a national registration number, 国械注准 or 国械注进, with class digit 3 and catalogue code 02-13-09 on the certificate, and read the approved scope ⁴⁵. A provincial number with class digit 2 under code 14-10-08 is a liquid dressing registered for barrier coverage of non-chronic wounds; it answers a different tender.

Private label, any market. Start from the register-visible manufacturers rather than from brands. In the United States that is the clearance-holder half of the GUDID list; in Europe it is the six manufacturers in the topical cohort, two of them already manufacturing for other companies' brands ²³.

Two judgments follow from the evidence and are labelled as VEMERIX analysis. First, legal-manufacturer records can shorten the search for the party accountable for technical documentation. Access to design, sterilization and stability evidence still depends on the supply/quality agreement and the actual manufacturing arrangement. Second, the absence of Chinese applicants from the MPN list and their presence in the EU register at Class IIa means the origin question should be asked per market rather than once: a Chinese manufacturer can be a qualified EU supplier and, at the same time, not a US supplier at all.

Methodology and limitations

This report rests on five datasets we analysed ourselves, the regulatory texts that define the product in each market, and a literature check for context.

• FDA 510(k), classification and PMA exports of August 24, 2026: 175,559 premarket notifications, 7,084 product codes and 56,765 PMA rows. The cohort rule was product code MPN; keyword matches outside MPN were reviewed and excluded ¹⁹¹⁰.
• FDA GUDID (openFDA UDI export) of August 24, 2026: 5,083,948 device records streamed in 21 partitions; 97 records with product code MPN; each labeler matched by name to the 510(k) applicant list, with two documented aliases (B. Braun for Aesculap-brand Histoacryl; SkinStitch for GluStitch Twist) ².
• EUDAMED public device data of August 24, 2026: 2,926,029 records streamed in 20 partitions; 100 keyword matches sorted by trade name into five cohorts ³.
• NMPA UDI full release of September 1, 2026: 6,139,557 records; 7,184 broad keyword matches; 239 topical and tissue adhesive records by device name; registration numbers parsed for prefix and class digit ⁵.
• Trade: CEPII BACI HS17 version 202601 for product 300610, 2017 to 2024, and UN Comtrade annual data pulled on September 12, 2026 for the United States (imports 2019 to 2024, exports 2024), China, Germany, the United Kingdom and India ⁶⁷.
• Regulatory texts verified on September 12, 2026: 21 CFR 878.4010, 878.4011, 880.5090 and 801.3, the FDA special controls guidance and reclassification rule of 2008, MDCG 2021-24 Rev.1, the EUDAMED overview, NMPA announcement 2017 No. 104 and the US tariff schedule ^{481311161719212226}.
• Literature: Europe PMC returned 781 records for cyanoacrylate in wound closure, rising from 23 in 2015 to 59 in 2025, and only 16 that address shelf life or sterility; García Cerdá and colleagues' 2015 review in Surgery Today provides a broad survey of surgical use ²⁸. No clinical claim in this report rests on that literature.

Limitations, stated once here and where they first bite in the text:

1. Registers record authorizations and identifiers, not sales, capacity or current marketing. A holder may have stopped selling without withdrawing a clearance.
2. The openFDA GUDID export leaves the sterility field blank for every MPN record, so sterility could not be tabulated.
3. EUDAMED registration became mandatory on May 28, 2026; the snapshot under-represents legacy devices, and missing brands are a coverage limit, not a finding.
4. NMPA UDI classification codes and registration numbers are labeler-entered; three provincial Class II numbers carry a Class III code, and this report flags rather than resolves that.
5. HS 3006.10 bundles sutures, haemostatics, laminaria and adhesives; no product-family share is observed. Values bound only the adhesive subset within the selected heading and flow.
6. Applicant and manufacturer addresses are legal addresses, not necessarily manufacturing sites.
7. The extracted product-code fields do not confirm chemistry. MPN includes non-cyanoacrylate products such as BondEase. Verify the monomer in the specific label, IFU and authorization summary.

Frequently asked questions

Can a distributor sell an FDA-cleared skin adhesive under its own brand without a new 510(k)?

It can, subject to the product, labeling and applicable regulatory obligations. The labeler definition in 21 CFR 801.3 identifies responsibility; it is not itself an exemption from premarket review. FDA states that repackagers or relabelers may need a new 510(k) when labeling or device changes meet the submission threshold. ¹⁹²⁹ The GUDID cohort shows this in practice: nine of the 20 MPN labelers hold no clearance and account for 44 of 97 records ². The buyer's question is which clearance and which manufacturer stand behind the brand.

Does the FDA clearance list tell me whether a product is 2-octyl or n-butyl cyanoacrylate?

No. None of the 36 MPN device names in the 510(k) export states its monomer, so the chemistry has to be read from the label, the instructions for use or the 510(k) summary ¹. The same is true of the EU and Chinese registers, where the chemistry appears only when the manufacturer put it in the product name, as several Chinese Class III holders did ⁵.

Why does a Chinese "Class II medical adhesive" not satisfy a surgical closure tender?

Because the NMPA catalogue places adhesives for closure of surgical incisions at the skin surface (code 02-13-09) in Class III, and places barrier liquids for non-chronic wounds (code 14-10-08) in Class II ⁴. In the NMPA UDI cohort, eight of the twelve provincial Class II numbers carry a 14-10 code ⁵. A Class II number therefore usually points to a product registered as a dressing, and the certificate's approved scope settles it.

Why is LiquiBand missing from the EUDAMED figures?

The extract cannot establish the reason. It dates from August 24, 2026, within the registration transition for qualifying previously marketed devices, and uses a bounded keyword rule. Search the exact manufacturer and device identifier and obtain the current conformity documents before drawing a status conclusion. ²²²³³

Conclusion

Three registers, three supplier populations. The United States has cleared 36 topical skin adhesives from 14 applicant groups in seventeen years, none from mainland China, and almost half of the MPN identifiers in this snapshot belong to labelers without a matched applicant. The European register, still filling, already shows two Chinese manufacturers at Class IIa and a US manufacturer behind two European brands. China's own register divides the product between a Class III adhesive code and a Class II dressing code, and the class digit in a registration number tells a buyer which one they are looking at. The trade heading that bundles all of this with sutures benchmarks none of it.

The RFQ that follows from the evidence asks each bidder for the identifier its market uses, names the holder behind any relabelled brand, and treats "Class II" as a question to ask rather than an answer to accept.

Procurement teams and distributors building a private-label wound closure range can request the registration file for the VEMERIX Medical Adhesive for their target market from our regulatory team. We will tell you which register it sits in and what the approved scope says.