P200, P200Dx
by Optos plc United Kingdom EUDAMED
Ref A1021Model P200, P200Dx
EMDN Z12120114
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-A1021KD | Date28 May 2025 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/MDD Expiring (legacy directive)
Specification
- Device Name
- Panoramic Ophthalmoscope 200
- Model / Reference
- P200, P200Dx, A1021
- Primary DI / UDI-DI
- D-A1021KD
- Basic UDI-DI
- B-A1021KD
- EMDN Code
- Z12120114 Ophthalmoscopes
- Device Class
- Class IIa
Manufacturer details
- EUDAMED SRN
- GB-MF-000019460
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Optos plc
Properties & raw data
Show properties, registry sources and raw records
Other properties (11)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED cc7f2d5a-d007-4ac8-b4e2-82c566da9a4f