Viral DNA/RNA Kit
by Jiangsu CoWin Biotech Co., Ltd. 2 variants
Ref CWX101SModel CWX101S/CWX101M
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 | Number697445472V21003X10146 06974454727285 | Date26 Oct 2023 | 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- Withdrawn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
- Device Name
- Viral DNA/RNA Kit
- Model / Reference
- CWX101S/CWX101M, CWX101S
- Primary DI / UDI-DI
- 06974454727285
- Basic UDI-DI
- 697445472V21003X10146
- Direct Marketing DI
- 06974454727285
- EMDN Code
- W0105900101 Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus
- Device Class
- Class A
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000008981
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Other devices from Jiangsu CoWin Biotech Co., Ltd.
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