Unknown / Not in EUDAMED

Snapshot 2026-10-11 · Link to EUDAMED

OFTAlacrim (HAPlusP-005)

UDI-DI 08054085122104Basic UDI-DI 80540851221NP

Class IIb · MDR · ENABLE INNOVATIONS SRL

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Identification

Model: Gocce oculari 0,4% HA Plus
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

FourHyal Plus (HAPlusM-001) 08054085121077
FourHyal Plus (HAPlusP-001) 08054085121084
Gocce oculari lubrificanti (HAPlusP-004) 08054085122036
Irivist Gocce oculari (HAPlusM-002) 08030243038951
Irivist Gocce oculari (HAPlusP-002) 08030243038944
Irivist Gocce oculari (HAPlusP-002) 08030243038982
Nutrilen Dry eyes (HAPlusP-003) 08054085122029
Nutrilen Dry eyes (HAPlusP-003) 08054085122012
Optikomax (HAPlusP-006) 08054085122470

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/oftalacrim-haplusp-005-2104 · UDI page: /udi/08054085122104

All devices from ENABLE INNOVATIONS SRL

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