Unknown / Not in EUDAMED

Snapshot 2026-10-12 · Link to EUDAMED

KROPLE DO OCZU. KWAS HIALURONOWY 0,4% (GOHAP-004)

UDI-DI 08054085122289Basic UDI-DI 80540851217NY

Class IIb · MDR · ENABLE INNOVATIONS SRL

Scan an inventory CSV

Identification

Model: Gocce oculari 0,4% HA
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

Aactive HA PF 0,4% (GOHAP-003) 08054085122258
Collirio Alfa Occhio secco (GOHAP-005) 08054085122296
FourHyal (GOHAM-001) 08054085120018
FourHyal (GOHAP-001) 08054085120025
Innodrops FourHyal (GOHAM-002) 08054085122326
Innodrops FourHyal (GOHAP-006) 08054085122333
Lubryval 0,4% (GOHAM-003) 08054085122616
Wops' Gotas oftalmicas Ultra hidratantes (GOHAP-002) 08054085122203

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/krople-do-oczu-kwas-hialuronowy-0-4-gohap-004-2289 · UDI page: /udi/08054085122289

All devices from ENABLE INNOVATIONS SRL

Scan an inventory CSV