Auto Ref-Keratometer
by POTEC Co., Ltd. South Korea EUDAMED
Ref PRK-6000, PRK-7000, PRK-5000Model PRK-5000, PRK-6000, PRK-7000, PRK-8000
EMDN Z12120113
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberB-08809240011065 | Date8 Aug 2023 | StatusWithdrawn |
| European Union | CE/MDD | NumberB-08809240011065 | Date8 Aug 2023 | StatusWithdrawn |
Coverage
- Withdrawn
- Not covered
European Union — CE/MDR, CE/MDD Withdrawn
Specification
- Device Name
- Auto Ref-Keratometer
- Model / Reference
- PRK-6000, PRK-7000, PRK-5000, PRK-8000
- Primary DI / UDI-DI
- 08809240011065, 08809240011072, 08809240011058
- Basic UDI-DI
- B-08809240011065, B-08809240011072, B-08809240011058, 880924001PRKNW
- EMDN Code
- Z12120113, Z12120113,Z12120199
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- KR-MF-000012281
- Authorised representative
- MDSS GmbH DE-AR-000005430
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- 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
- Incorporates Medicinal Product: No
Sources (4)
- EUDAMED 2276e026-7578-4ab8-b5d1-c63c336bf125
- EUDAMED 08809240011072|B-08809240011072
- EUDAMED 08809240011058|B-08809240011058
- EUDAMED 08809240011065|880924001PRKNW