KEYU Sample Collection Cup
by Zhuhai Keyu Biological Engineering Co., Ltd China EUDAMED
Ref KU-CUP-002
EMDN W05019001
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697473536KUC07PS | Date7 May 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Sample Collection Cup
- Model / Reference
- KU-CUP-002
- Primary DI / UDI-DI
- 06974735360675
- Basic UDI-DI
- 697473536KUC07PS
- EMDN Code
- W05019001 Faeces collection devices
- Device Class
- Class A
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000023195
- 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 (10)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED 59be8854-cbc4-4e49-836d-d7719558bc92