Auto Ref-Keratometer
by POTEC Co., Ltd. South Korea EUDAMED
Ref PRK-8000
EMDN Z12120113
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-08809240011089 | Date21 Apr 2023 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/MDD Expiring (legacy directive)
Specification
- Device Name
- Auto Ref-Keratometer
- Model / Reference
- PRK-8000
- Primary DI / UDI-DI
- 08809240011089
- Basic UDI-DI
- B-08809240011089
- EMDN Code
- Z12120113 Ophthalmometers
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- KR-MF-000012281
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from POTEC Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (10)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 46c0d4ef-0367-4acc-ad11-1fa14d128cc1