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UDI Compass
Certificate valid

Snapshot 2026-10-09 · Link to EUDAMED

Verification Plan

UDI-DI 08052675960556Basic UDI-DI 805267596SurgicalInstrD9

Class I · MDR · ORTHOKEY ITALIA SRL

Identification
Model
ORTHOKEY Surgical instruments IR
EMDN
L0999
Issuing agency
GS1
Device status
active
Sterile
No
Implantable
No
Measuring function
No
Reusable surgical
Yes
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

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Canonical device page: /device/verification-plan-0556 · UDI page: /udi/08052675960556

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