Ocuscreen
Ref Ocuscreen 1
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberPP13678OCUSCREEN37 1313678OCUSCREEN1033 | Date4 Jun 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Ocuscreen
- Model / Reference
- Ocuscreen 1
- Primary DI / UDI-DI
- 1313678OCUSCREEN1033
- Basic UDI-DI
- PP13678OCUSCREEN37
- EMDN Code
- V92 Medical device software - not included in other classes
- Device Class
- Class IIa
- Special Device Type
- Software
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000045145
Other devices from Ocumeda GmbH
Properties
Other properties (13)
- Sterile: No
- 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