Occhi+Fresh gocce oculari (GOF1aP-002)
by Enable Innovations SRL Italy EUDAMED
Ref 050324Model Gocce oculari Innodrops F1a EMDN Q0299
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number80540851201NH | Date20 Apr 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- 0425-MDR-030020-01 Supplemented
Quality management system EU MDR
- Notified body
- ICIM S.P.A. 0425
- Issued
- 26 Mar 2025
- Expires
- 26 Feb 2028
- Reason
- Other
Specification
- Device Name
- Gocce oculari Innodrops F1a
- Model / Reference
- Gocce oculari Innodrops F1a, 050324
- Primary DI / UDI-DI
- 08054085120834
- Basic UDI-DI
- 80540851201NH
- EMDN Code
- Q0299 Ophthalmic devices - other
- Device Class
- Class IIb
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000026066
Other devices from Enable Innovations SRL
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED f9b68638-38a2-43e2-ab1a-e72f84c18259