Disposable stool sample collection kit
by Miraclean Technology Co., Ltd
Ref FB-YT01
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 | Number697189332DSSCKRT 06971893325294 | Date20 Oct 2026 | 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- Withdrawn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
- Model / Reference
- FB-YT01
- Primary DI / UDI-DI
- 06971893325294
- Basic UDI-DI
- 697189332DSSCKRT
- Direct Marketing DI
- 06971893325294
- EMDN Code
- W05019001 Faeces collection devices
- Device Class
- Class A
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000011683
- Authorised representative
- Share info GmbH DE-AR-000005132
Other devices from Miraclean Technology 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