TANBead Nucleic Acid Extraction Kit
by Taiwan Advanced Nanotech Inc. EUDAMED
Active
Ref W61GA46-SEModel 61G series
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number47198801261GHB | Date20 Dec 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
- Device Name
- TANBead Nucleic Acid Extraction Kit
- Model / Reference
- 61G series, W61GA46-SE
- Primary DI / UDI-DI
- 04719880122981
- Basic UDI-DI
- 47198801261GHB
- Direct Marketing DI
- 04719880122981
- EMDN Code
- W0105900101 Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus
- Device Class
- Class A
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- TW-MF-000019040
- Authorised representative
- mdi Europa GmbH DE-AR-000006218
Other devices from Taiwan Advanced Nanotech INC.
Properties
Other properties (8)
- Sterile: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No