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UDI Compass
Certificate valid

Snapshot 2026-10-09 · Link to EUDAMED

ONYX

UDI-DI 03760172650515Basic UDI-DI 3760172650XRAYMOBILEWF

Class IIb · MDR · APELEM

Identification
Model
—
Issuing agency
GS1
Device status
active
Sterile
No
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

EPT 0477.MDR.26/6188

EU quality management system · valid

Notified body: Eurofins Product Testing Italy S.r.l. (0477)

Valid from 2026-06-09 · Expiry 2031-06-08

Scope not stated in certificate data.

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

Manufacturer

APELEM

SRN FR-MF-000008953

FR · Gallargues-le-Montueux - FRANCE

manufacturer

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/onyx-0515 · UDI page: /udi/03760172650515

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