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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-12 · Link to EUDAMED

Optinal fresh (GOF2M-004)

UDI-DI 06297001028384Basic UDI-DI 80540851203NM

Class IIb · MDR · ENABLE INNOVATIONS SRL

Identification
Model
Gocce oculari Innodrops F2
EMDN
Q0299
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

0425-MDR-030020-01

EU quality management system · unknown

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

Valid from 2025-03-26 · Expiry 2028-02-26

Scope not stated in certificate data.

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

Manufacturer

ENABLE INNOVATIONS SRL

SRN IT-MF-000026066

IT · CARPI (MO)

manufacturer

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/optinal-fresh-gof2m-004-8384 · UDI page: /udi/06297001028384

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