Direct Ophthalmoscope
by Suzhou Kangjie Medical Inc. China EUDAMED
Ref KJ8B
EMDN Z12120114
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697466603KJ8BP4 | Date9 Jun 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Direct Ophthalmoscope
- Model / Reference
- KJ8B
- Primary DI / UDI-DI
- 06974666030128
- Basic UDI-DI
- 697466603KJ8BP4
- Direct Marketing DI
- 06974666030128
- EMDN Code
- Z12120114 Ophthalmoscopes
- Device Class
- Class I
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000008792
- Authorised representative
- Kingsmead Service B.V. NL-AR-000002066
Other devices from Suzhou Kangjie Medical, Inc.
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 111490fb-773e-44e5-9198-3b51abc26273