Certificate valid

Snapshot 2026-10-09 · Link to EUDAMED

GO-TWO

UDI-DI 03665318025502Basic 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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Canonical device page: /device/go-two-5502 · UDI page: /udi/03665318025502

All devices from CONCEPTION ET FABRICATION DE PRODUITS MEDICAUX ET PARAMEDICAUX

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