02Surgical · Urology
Circumcision Anastomat Kit
Disposable circumcision anastomat — adult & children kits.
Classification
Class II
NMPA Reg.
Lu Mech Reg. 20162020372
A complete single-use kit pairing the circumcision anastomat with the consumables required for the procedure. Available as Adult and Children variants for high-throughput urology programs.
KEY FEATURES
What makes it work.
- Pre-bundled, ready for the OR
- Adult and Children kit variants
- Single-use, sterile, individually packaged
- Designed for consistent staple lines
APPLICATIONS
Where it's used.
- Treatment of phimosis
- Treatment of redundant prepuce
SPECIFICATIONS
Technical specifications.
Classification
Class II medical device
NMPA registration
Lu Mech Reg. 20162020372
Variants
Adult kit · Children kit
Sterilization
Ethylene oxide (EO)
FROM VEMERIX INSIGHTS
Market analysis behind this product
Regulatory Guide
Registering and Distributing Disposable Circumcision Devices: A US (FDA 510(k)), EU (MDR) and China (NMPA) Market-Entry Evidence Pack for Distributors and Private-Label Buyers
A multi-jurisdiction regulatory matrix and distributor evidence checklist comparing US 21 CFR 884.4530, EU MDR Class IIa Rule 6, China provincial Class II NMPA registrations, and WHO prequalification gates.
August 17, 2026 · 19 min read
Regulatory Guide
How to Verify a Chinese Medical Device Registration: A Distributor's Guide to Reading an NMPA Certificate Number, Checking Validity, Scope and Cancellations
A practical five-check verification workflow, certificate-number decoder, public database guide, and distribution-agreement evidence schedule for international distributors qualifying Chinese medical-device suppliers.
August 16, 2026 · 16 min read
Regulatory Guide
How Sterile Procedure Kits Are Regulated: FDA Convenience-Kit Rules, EU MDR Article 22, and the Evidence Pack an Assembler, Distributor, or OEM Buyer Must Verify
A definitive regulatory pathway, post-market recall analysis, and supplier-qualification checklist for multi-component sterile procedure trays, circumcision kits, puncture sets, and dressing packs.
August 15, 2026 · 18 min read
Buyer Guide
What the FDA MAUDE and Recall Record Reveals About Surgical Stapler Failures: A Post-Market Evidence Map for Surgical Stapler Procurement and Supplier Screening (2015–2026)
An original FDA post-market surveillance analysis of 3,645 MAUDE medical device reports, Class I/II recalls, and the 2021 Class II reclassification order (21 CFR 878.4740, product code GAG) translated into tender specifications, acceptance testing, and supplier-screening criteria for disposable surgical and circumcision stapler procurement.
August 13, 2026 · 16 min read
Buyer Guide
What the FDA MAUDE and Recall Record Reveals About Circumcision Device Failures: A Post-Market Evidence Map for Circumcision Procurement and Supplier Screening (2015–2026)
An original FDA surveillance analysis of 31 circumcision device 510(k) clearances, 34 recalls, and 942 MAUDE adverse-event reports (all-time; 592 in the 2015–2026 window) translated into tender acceptance criteria and supplier-vigilance questions for disposable circumcision stapler, ring, and clamp devices.
August 11, 2026 · 16 min read
Technical Guide
Disposable Circumcision Anastomat and Stapler: Device Mechanics, Sterile-Kit Components and Lot-Acceptance Tests for Procurement and Biomedical Engineering
A component-level technical guide to the single-use circumcision anastomat and stapler: the bell-and-staple firing mechanism, what belongs in the sterile convenience kit, the staple-formation and sterile-barrier lot-acceptance tests, and the US, EU and China classification — including why no US 510(k) predicate and no WHO prequalification exist for the stapler.
August 9, 2026 · 18 min read
Buyer Guide
Qualifying a Circumcision Device Manufacturer or Distributor Program: CE Evidence, QMS Scope, Legal-Manufacturer Role and Registration-Document Control
A practical audit and qualification checklist for distributors and private-label buyers evaluating circumcision device manufacturers, distinguishing ISO 13485 from product-specific CE certificates, defining legal-manufacturer obligations, and protecting territory exclusivity.
August 5, 2026 · 24 min read
Buyer Guide
Disposable Circumcision Device Bulk Price, MOQ and Landed Cost: A Quote-Normalization and Total-Cost Worksheet for Distributors and Bulk Buyers
A B2B procurement framework for turning ex-works device quotes into defensible landed-cost-per-unit figures, incorporating size-mix MOQ, sterile packaging, tariff treatment, customs classification, and lot-release terms.
August 5, 2026 · 22 min read
Buyer Guide
Disposable Circumcision Device Sizing and Portfolio Selection: A Distributor and Procurement Guide for Ring, Anastomat or Stapler and Kits (Adult versus Pediatric)
Matching device mechanics to clinical throughput, establishing adult and pediatric size ladders, and verifying FDA, CE, and NMPA registration evidence.
August 3, 2026 · 22 min read
Technical Guide
Ethylene Oxide Sterilization Validation for Single-Use Medical Devices: An ISO 11135 Process, ISO 10993-7 Residual and FDA Evidence Guide for OEM and Private-Label Buyers
Qualifying a sterile single-use device OEM demands a validated ISO 11135 process, documented ISO 10993-7 residual dissipation profiles below 4 mg EO / 9 mg ECH for limited contact, clear parametric or BI release protocols, and a regulatory change-control strategy under the FDA Sterilization Master File pilots.
August 3, 2026 · 16 min read
Market Analysis
From Scalpel-and-Suture to a Single Click: The Disposable Circumcision Device Shift
How single-use rings, circular staplers and disposable-suture kits turned a 20-minute scalpel-and-suture operation into a roughly 7-minute sutureless one — an Asia-led device shift the world adopted before the US FDA recorded it.
July 6, 2026 · 28 min read
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Ready to evaluate Circumcision Anastomat Kit?
Sample units typically ship under 10 business days for qualified buyers. Distributors — ask about territory exclusivity.