Certificate valid

Snapshot 2026-10-09 · Link to EUDAMED

CAT-FILE

UDI-DI 03665318027162Basic UDI-DI 3665318FILE001NY

Class IIa · MDR · CONCEPTION ET FABRICATION DE PRODUITS MEDICAUX ET PARAMEDICAUX

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Identification

Model: Sterile Niti Engine Files
EMDN: Q010507
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

0425-MDR-030134-01

EU quality management system · valid

Notified body: ICIM S.P.A. (0425)

Valid from 2026-06-15 · Expiry 2030-06-29

Scope not stated in certificate data.

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

Manufacturer

CONCEPTION ET FABRICATION DE PRODUITS MEDICAUX ET PARAMEDICAUX

SRN FR-MF-000010345

FR · Tremblay-en-France

manufacturer

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All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/cat-file-7162 · UDI page: /udi/03665318027162

All devices from CONCEPTION ET FABRICATION DE PRODUITS MEDICAUX ET PARAMEDICAUX

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