KEYU Sample Collection Cup
by Zhuhai Keyu Biological Engineering Co., Ltd 4 variants
Ref KU-CUP-003
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697473536KUC07PS 06974735360729 | Date7 May 2025 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Sample Collection Cup
- Model / Reference
- KU-CUP-003
- Primary DI / UDI-DI
- 06974735360729
- Basic UDI-DI
- 697473536KUC07PS
- EMDN Code
- W05019001 Faeces collection devices
- Device Class
- Class A
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000023195
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
Other devices from Zhuhai Keyu Biological Engineering Co., Ltd
See all devices from Zhuhai Keyu Biological Engineering Co., Ltd →
Properties
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