Thermal cycler
by Hangzhou Bigfish Bio-tech Co., Ltd. China EUDAMED
Ref FC-96BEModel FC-96B,FC-96BE,FC-96GE,FC-96D,FC-96G.FC-384G,FC-1536G,FC-48D,FC-48N,FC-48T EMDN W02050116
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697551436ThermalcyclerDH | Date6 Aug 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Thermal cycler
- Model / Reference
- FC-96B, FC-96BE, FC-96GE, FC-96D, FC-96G.FC-384G, FC-1536G, FC-48D, FC-48N, FC-48T
- Primary DI / UDI-DI
- 06975514360848
- Basic UDI-DI
- 697551436ThermalcyclerDH
- EMDN Code
- W02050116 Nucleic acid testing integrated extraction /amplification /detection systems
- Device Class
- Class A
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000027212
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Hangzhou Bigfish Bio-tech Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- New Device: No
Sources (1)
- EUDAMED 06975514360848|697551436THERMALCYCLERDH