virus collection and preservation system
by Jiangsu KangJian Medical Apparatus Co., Ltd.
Ref KJ502A, KJ502B, KJ502C, KJ502DModel inactivated, non-inactivated, extraction-free
Active
CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-virusc&psystemET D-virusc&psystemET | Date7 Jun 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- Withdrawn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/IVDD Active
Specification
- Model / Reference
- inactivated, non-inactivated, extraction-free, KJ502A, KJ502B, KJ502C, KJ502D
- Primary DI / UDI-DI
- D-virusc&psystemET
- Basic UDI-DI
- B-virusc&psystemET
- EMDN Code
- W05019099 Samples collection devices - other
- Device Class
- Class IVD General
- EU market of registration
- Portugal
Manufacturer details
- EUDAMED SRN
- CN-MF-000018938
- Authorised representative
- Zoustech S.L. ES-AR-000002008
Other devices from Jiangsu KangJian Medical Apparatus Co., Ltd.
See all devices from Jiangsu KangJian Medical Apparatus Co., Ltd. →
Properties
Other properties (10)
- 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