Breath Sampling Vial
by Zhejiang ALWSCI Technologies Co., Ltd. EUDAMED
Active
Ref C0003562Model C0003346, C0003186, C0003507, C0002598, C0003560, C0003561, C0003562, C0003563, C0003564, C0003565, C0003566, C0003567, C0003568, C0003569, C0003570, C0003571
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697583867ALWSCI12BTVVN | Date29 May 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Breath Sampling Vial
- Model / Reference
- C0003346, C0003186, C0003507, C0002598, C0003560, C0003561, C0003562, C0003563, C0003564, C0003565, C0003566, C0003567, C0003568, C0003569, C0003570, C0003571
- Primary DI / UDI-DI
- 16095672035628
- Basic UDI-DI
- 697583867ALWSCI12BTVVN
- Unit of Use DI
- 06095672035621
- EMDN Code
- W0503010101 Samples analyses, glass tubes
- Device Class
- Class A
- Market of Registration
- France
Manufacturer details
- EUDAMED SRN
- CN-MF-000030658
- Authorised representative
- Kingsmead Service B.V. NL-AR-000002066
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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