Virus Collection and Preservation System
by Jiangsu KangJian Medical Apparatus Co., Ltd. EUDAMED
Active
Ref non-inactivated(colored), extraction-free, Inactivated(colored), 7945, Inactivated(colorless)Model Non-inactivated(colorless), Non-inactivated(colored), Universal, Extraction-free., Inactivated (colorless), inactivated (colored).
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69532113VCPS001R4 | Date16 Dec 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Model / Reference
- Non-inactivated(colorless), Non-inactivated(colored), Universal, Extraction-free., extraction-free, Inactivated (colorless), inactivated (colored)., Inactivated(colored), 7945, Inactivated(colorless)
- Primary DI / UDI-DI
- 06953211308745, 06953211308752, 06953211308721, 06953211379455, 06953211308714
- Basic UDI-DI
- 69532113VCPS001R4, 69532113VCPS002R6
- EMDN Code
- W05019099 Samples collection devices - other
- Device Class
- Class A
- Market of Registration
- SpainGermany
Manufacturer details
- EUDAMED SRN
- CN-MF-000018938
- Authorised representative
- Zoustech S.L. ES-AR-000002008
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Properties
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