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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-12 · Link to EUDAMED

Osmotears Low OS 280 (OS280-001)

UDI-DI 08054085120643Basic UDI-DI 80540851220NM

Class IIb · MDR · ENABLE INNOVATIONS SRL

Identification
Model
Goccia oculare Osmotears Low 280
EMDN
Q0299
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

0425-MDR-030119-01

EU quality management system · unknown

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

Valid from 2026-02-25 · Expiry 2030-02-02

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

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/osmotears-low-os-280-os280-001-0643 · UDI page: /udi/08054085120643

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