Unknown / Not in EUDAMED

Snapshot 2026-10-19 · Link to EUDAMED

PROLENE

UDI-DI 10705031128248Basic UDI-DI 0705031a012584Z

Class III · MDR · Ethicon, LLC

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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 753191

EU technical documentation assessment · unknown

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

Valid from 2026-06-19 · Expiry 2028-07-19

Scope not stated in certificate data.

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

Manufacturer

SRN US-MF-000013112

US · San Lorenzo, Puerto Rico

manufacturer

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

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Showing 12 of 854 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/prolene-8248 · UDI page: /udi/10705031128248

All devices from Ethicon, LLC

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