Optinal fresh (GOF2M-004)
by Enable Innovations SRL Italy EUDAMED
Ref 050316, 050315Model Gocce oculari Innodrops F2 EMDN Q0299
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number80540851203NM | Date21 Apr 2026 | StatusWithdrawn |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Withdrawn
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 F2
- Model / Reference
- Gocce oculari Innodrops F2, 050316, 050315
- Primary DI / UDI-DI
- 06297001028377, 06297001028384
- Basic UDI-DI
- 80540851203NM
- EMDN Code
- Q0299 Ophthalmic devices - other
- Device Class
- Class IIb
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 (2)
- EUDAMED 9d6b853e-9ecc-4ba6-88d9-43113c9dccf4
- EUDAMED 06297001028384|80540851203NM