Unknown / Not in EUDAMED

Snapshot 2026-10-10 · Link to EUDAMED

PROLENE

UDI-DI 10705031091610Basic UDI-DI 0705031a012574X

Class III · MDR · Ethicon, LLC.

Scan an inventory CSV

Identification

Model: PROLENE Suture
EMDN: H010201010401, H010201010402
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: Yes
Measuring function: No
Reusable surgical: No

Certificates

MDR 719658

EU technical documentation assessment · unknown

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

Valid from 2026-06-05 · Expiry 2028-07-04

Scope not stated in certificate data.

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

Manufacturer

SRN US-MF-000013111

US · Guaynabo, Puerto Rico

manufacturer

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

Related UDI-DIs

PROLENE 10705031100947
PROLENE 10705031073166
PROLENE 10705031100985
PROLENE 10705031072596
PROLENE 10705031096585
PROLENE 10705031098404
PROLENE 10705031111677
PROLENE 10705031101296
PROLENE 10705031101630
PROLENE 10705031097285
PROLENE 10705031100367
PROLENE 10705031103610

Showing 12 of 66 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/prolene-1610 · UDI page: /udi/10705031091610

All devices from Ethicon, LLC.

Scan an inventory CSV