Unknown / Not in EUDAMED

Snapshot 2026-10-11 · Link to EUDAMED

VizOpti Preservative-Free Eye Mist (SO1-003)

UDI-DI 05060133379119Basic UDI-DI 80540851207NV

Class IIb · MDR · ENABLE INNOVATIONS SRL

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Identification

Model: Spray oftalmico SO1
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

Lipofresh Spray oftalmico (SO1-001) 08054085120322

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/vizopti-preservative-free-eye-mist-so1-003-9119 · UDI page: /udi/05060133379119

All devices from ENABLE INNOVATIONS SRL

Scan an inventory CSV