Feces Analysis System
by Xiamen Sciendox Biological Technology Co., Ltd. China EUDAMED
Ref 6000R
EMDN W0101060399
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697112411FAS00137 | Date17 Feb 2023 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Feces Analysis System
- Model / Reference
- 6000R
- Primary DI / UDI-DI
- 06971124110026
- Basic UDI-DI
- 697112411FAS00137
- Direct Marketing DI
- 06971124110026
- EMDN Code
- W0101060399 Faeces tests - rapid tests and "point of care" - other
- Device Class
- Class A
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000029485
- Authorised representative
- MedPath GmbH DE-AR-000000087
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Properties & raw data
Show properties, registry sources and raw records
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- New Device: No
Sources (1)
- EUDAMED 4c8b127a-0d7e-4fb2-a483-77e77d34c4c3