03Surgical · Urology
Disposable Sterile Circumcision Device
One-step sterile circumcision device for outpatient urology.
Classification
Class II
NMPA Reg.
Lu Mech Reg. 20222021157
A fully sterile, single-use circumcision device designed for outpatient and ambulatory surgical centers. Streamlines procedure prep and reduces cross-contamination risk.
KEY FEATURES
What makes it work.
- Factory-sterilized — no in-clinic reprocessing
- Single-pass design
- Compatible with adult anatomical variations
- Optimized for outpatient throughput
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. 20222021157
Sterilization
Factory EO sterilized
FROM VEMERIX INSIGHTS
Market analysis behind this product
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
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
Regulatory Guide
Design Transfer and Change Control for Medical Devices: A QMSR / ISO 13485 Handover and Change-Classification Checklist for Legal Manufacturers and Contract Manufacturers
A practical regulatory checklist for legal manufacturers, OEM brand owners, and contract manufacturers executing design transfer and classifying post-market changes under FDA QMSR, ISO 13485, EU MDR, and NMPA.
August 3, 2026 · 16 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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Sample units typically ship under 10 business days for qualified buyers. Distributors — ask about territory exclusivity.