Real-time Fluorescent Quantitative PCR Analyzer
by Hangzhou Bigfish Bio-tech Co., Ltd. China EUDAMED
Ref BFQP-1620Model BFQP-48、BFQP-96、BFQP-16 EMDN W02050301
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697551436BFQP001PX | Date24 Feb 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Real-time Fluorescent Quantitative PCR Analyzer
- Model / Reference
- BFQP-48、BFQP-96、BFQP-16, BFQP-1620
- Primary DI / UDI-DI
- 06975514361043
- Basic UDI-DI
- 697551436BFQP001PX
- EMDN Code
- W02050301 Nucleic acid testing apparatuses - rapid and point of care tests
- 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 defd8984-bf39-4c8b-9f37-968efcd4bf6f