Breath Sampling Vial
by Zhejiang ALWSCI Technologies Co., Ltd. 101 variants
Ref C0002156Model C0002130
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 | Number697583867ALWCI12NCEQL 16095672021546 | Date18 Nov 2022 | 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- Withdrawn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
- C0002130, C0002156
- Primary DI / UDI-DI
- 16095672021546
- Basic UDI-DI
- 697583867ALWCI12NCEQL
- Unit of Use DI
- 06095672021549
- EMDN Code
- W0503010101 Samples analyses, glass tubes
- Device Class
- Class A
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000030658
- Authorised representative
- Kingsmead Service B.V. NL-AR-000002066
Other devices from Zhejiang ALWSCI Technologies Co., Ltd.
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Properties
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