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UDI Compass
Certificate valid

Snapshot 2026-10-13 · Link to EUDAMED

Robin Navigation Unit

UDI-DI 08052675961010Basic UDI-DI 805267596Robin2U

Class IIa · MDR · ORTHOKEY ITALIA SRL

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

IT348354

EU quality management system · valid

Notified body: BUREAU VERITAS ITALIA S.P.A. (1370)

Valid from 2025-12-17 · Expiry 2030-12-16

Scope not stated in certificate data.

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

Manufacturer

ORTHOKEY ITALIA SRL

SRN IT-MF-000026488

IT · CARRARA (MS)

manufacturer

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/robin-navigation-unit-1010 · UDI page: /udi/08052675961010

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