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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-10 · Link to EUDAMED

PROLENE

UDI-DI 10705031073036Basic UDI-DI 0705031a0125953

Class III · MDR · Ethicon, LLC.

Identification
Model
Endosuture System Made with PROLENE Suture
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

Ethicon, LLC.

SRN US-MF-000013111

US · Guaynabo, Puerto Rico

manufacturer

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

Related UDI-DIs

No other UDI-DIs share this Basic UDI-DI in this snapshot.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/prolene-3036 · UDI page: /udi/10705031073036

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