Ophthalmoscope Set, PRIMA Classic, 2.5V WSB, Rechargeable Battery (Included)
by Medical Devices (Pvt) Ltd EUDAMED
Active
Ref 808-810-27
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number896110278OPHS808TN | Date22 Nov 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Ophthalmoscope
- Model / Reference
- 808-810-27
- Primary DI / UDI-DI
- 08961102783739
- Basic UDI-DI
- 896110278OPHS808TN
- EMDN Code
- Z12120114 Ophthalmoscopes
- Device Class
- Class I
- Market of Registration
- Malta
Manufacturer details
- EUDAMED SRN
- PK-MF-000021845
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from Medical Devices (Pvt) Ltd
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