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UDI Compass
Certificate valid

Snapshot 2026-10-10 · Link to EUDAMED

PROLENE

UDI-DI 10705031050471Basic UDI-DI 0705031a0136757

Class III · MDR · Ethicon, LLC

Identification
Model
PROLENE Polypropylene Mesh and PROLENE Soft Mesh
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
Yes
Measuring function
No
Reusable surgical
No
Certificates

MDR 753200

EU technical documentation assessment · valid

Notified body: BSI Group The Netherlands B.V. (2797)

Valid from 2026-09-09 · Expiry 2031-09-08

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

Ethicon, LLC

SRN US-MF-000013112

US · San Lorenzo, Puerto Rico

manufacturer

Authorised representative: Johnson & Johnson Medical GmbH (DE-AR-000007712)

Related UDI-DIs

Showing 12 of 19 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/prolene-0471 · UDI page: /udi/10705031050471

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