Breath Sampling Vial
by Zhejiang ALWSCI Technologies Co., Ltd. China EUDAMED
Ref C0002137Model C0002130
EMDN W0503010101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697583867ALWCI12NCEQL | Date18 Nov 2022 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- C0002130, C0002137
- Primary DI / UDI-DI
- 16095672020938
- Basic UDI-DI
- 697583867ALWCI12NCEQL
- Unit of Use DI
- 06095672020931
- EMDN Code
- W0503010101 Samples analyses, glass tubes
- Device Class
- Class A
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000030658
- Authorised representative
- Kingsmead Service B.V. NL-AR-000002066
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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
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED 59831d72-9491-4aca-b5f8-f08a9911af10