01Surgical · Urology
Circumcision Device
Self-detaching circumcision ring — adult and pediatric.
Classification
Class II
NMPA Reg.
Lu Mech Reg. 20172020238
A single-use, biodegradable circumcision ring that delivers consistent, sutureless results in both adult and pediatric urology. Available in 14 size codes and supplied sterile in individual blister packs.
KEY FEATURES
What makes it work.
- No-suture, no-bleeding circumferential resection
- Two ergonomic SKUs: Adult type and Children type
- EO-sterilized, individually packaged
- Self-detaching ring — short OR time, easy follow-up
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. 20172020238
Variants
Adult type · Children type
Sterilization
Ethylene oxide (EO)
Packaging
Individual blister, sterile
CE
Yes
FROM VEMERIX INSIGHTS
Market analysis behind this product
Regulatory Guide
How to Place a Medical Device on the Saudi Market in 2026: MDMA versus Authorized Representative versus Establishment License, SFDA Classes A–D, 2025 Fees, and the May 2026 Bundling Rules
An operational decision guide for international distributors, private-label/OEM buyers, and overseas manufacturers: navigating the Kingdom of Saudi Arabia's MDMA requirements under Law M/54, the Technical File Assessment route, SFDA Classes A–D (MDS-G008), the May 2025 fee schedule, the 3 May 2026 bundling criteria (MDS-G028), Authorized Representative mandates, importer establishment licensing, and port-clearance verification.
August 25, 2026 · 18 min read
Regulatory Guide
How to Place a Medical Device on the Great Britain Market in 2026: When a Valid CE Mark Is Enough, When UKCA Is Required, Appointing a UK Responsible Person, MHRA Registration, and the June 2025 PMS Rules That Already Apply
An operational decision guide for international distributors, OEM buyers, and non-UK manufacturers: navigating Great Britain's CE-recognition timelines (2028 vs 2030), UKCA requirements under UK MDR 2002, UK Responsible Person mandates, DORS registration and 2026 fees, Northern Ireland EUDAMED rules, and the in-force June 2025 post-market surveillance obligations.
August 23, 2026 · 19 min read
Regulatory Guide
How to Verify a CE Certificate for a Medical Device: A Distributor's Guide to Reading Notified-Body Certificates, NANDO Designation, Scope and Extended MDD Validity
A practical five-check verification workflow, Annex XII reading grid, NANDO designation guide, EUDAMED status decoder, and distribution-agreement schedule for international distributors qualifying European medical-device suppliers.
August 18, 2026 · 18 min read
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
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
Technical Guide
Radiation (Gamma, Electron-Beam and X-Ray) Sterilization Validation for Single-Use Medical Devices: An ISO 11137, VDmax and FDA Evidence Guide for OEM and Private-Label Buyers
Qualifying a radiation-sterilized single-use device OEM requires verifying an ISO 11137 validation protocol, substantiating the 25 kGy or 15 kGy sterilization dose via VDmax, selecting the optimal modality (gamma vs e-beam vs X-ray), capping polymer maximum doses, and aligning with the 4-month dose-audit interval under ISO 11137-1:2025 and the FDA Radiation Master File Pilot.
August 4, 2026 · 18 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
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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Sample units typically ship under 10 business days for qualified buyers. Distributors — ask about territory exclusivity.