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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-13 · Link to EUDAMED

Osmotears Ultra Low OS 180 (OS180-001)

UDI-DI 08054085120636Basic UDI-DI 80540851219P4

Class IIb · MDR · ENABLE INNOVATIONS SRL

Identification
Model
Goccia oculare Osmotears Ultra Low 180
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-ultra-low-os-180-os180-001-0636 · UDI page: /udi/08054085120636

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