Unknown / Not in EUDAMED

Snapshot 2026-10-13 · Link to EUDAMED

Ektal M (GOECP-004)

UDI-DI 08054085122500Basic UDI-DI 80540851218P2

Class IIb · MDR · ENABLE INNOVATIONS SRL

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Identification

Model: Gocce oculari EC+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

Contact Care Drops Plus (GOEC-005) 08054085122272
Ektal M (GOEC-003) 08054085122142
Protection Drop (GOEC-001) 08054085120032
Protection Drop (GOECP-001) 08054085122265
Protection Eye Drop (GOECP-002) 08054085122210
Redcare Eye Augentropfen Intens (GOECP-003) 08054085122364
Reflex Gocce oculari (GOEC-002) 08054085121800
Retane Sensitive (GOEC-004) 08054085122241

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/ektal-m-goecp-004-2500 · UDI page: /udi/08054085122500

All devices from ENABLE INNOVATIONS SRL

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