Real-time PCR system
by Hangzhou Bio-gener Technology Co., Ltd. EUDAMED
Active
Ref Q9602 Pro
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697541263PCRSPB | Date27 Mar 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
- Model / Reference
- Q9602 Pro
- Primary DI / UDI-DI
- 16975412631054
- Basic UDI-DI
- 697541263PCRSPB
- Direct Marketing DI
- 16975412631054
- EMDN Code
- W02050116 Nucleic acid testing integrated extraction /amplification /detection systems
- Device Class
- Class A
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000027988
- Authorised representative
- MedPath GmbH DE-AR-000000087
Other devices from Hangzhou Bio-gener Technology Co., Ltd.
See all devices from Hangzhou Bio-gener Technology Co., Ltd. →
Properties
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