Single-use Flexible Cystoscope
by Hunan Vathin Medical Instrument Co., Ltd. United States EUDAMED
Ref CY-S1B01R EMDN Z12020701
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697219748CY4E | Date19 Feb 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Single-use Flexible Cystoscope
- Model / Reference
- CY-S1B01R
- Primary DI / UDI-DI
- 06972197483802
- Basic UDI-DI
- 697219748CY4E
- EMDN Code
- Z12020701 Cystoscopes
- Device Class
- Class IIa
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000002593
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
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Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- 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 d6cead7d-51b6-4d17-bc41-a163867687c5