Specimen Container (Urine &Stool)
by Shanghai Bize Import and Export Co., Ltd China EUDAMED
Ref SH-160304Model SH-160304; SH-160305; SH-160306; SH-160307;
EMDN W05030199
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697587603ContainerBP | Date15 Jan 2024 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Specimen Container (Urine &Stool)
- Model / Reference
- SH-160304, SH-160305, SH-160306, SH-160307
- Primary DI / UDI-DI
- 06975876038003
- Basic UDI-DI
- 697587603ContainerBP
- EMDN Code
- W05030199 Samples analyses, containers - other
- Device Class
- Class A
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000037405
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Shanghai Bize Import and Export Co., Ltd
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Properties & raw data
Show properties, registry sources and raw records
Other properties (11)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED e2d49284-263d-46a3-92b6-cae0b8f61874