Automatic Sperm Analyzer(including sperm counting slide &related kits)
by Xuzhou Qibo Electronic Technology Co., Ltd
Ref TSP-201Model TSP-201 TSP-301 TSP-302 QB-200A QB-200B QB-200C QB-300A QB-300B QB-300C QB-400A QB-400B QB-400C QA-1 QA-2 QA-3 TSP-202 TSP-206
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 | Number697683292QBASA012U 06976832920004 | 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- Withdrawn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
- Automatic Sperm Analyzer(including sperm counting slide &related kits)
- Model / Reference
- TSP-201 TSP-301 TSP-302 QB-200A QB-200B QB-200C QB-300A QB-300B QB-300C QB-400A QB-400B QB-400C QA-1 QA-2 QA-3 TSP-202 TSP-206, TSP-201
- Primary DI / UDI-DI
- 06976832920004
- Basic UDI-DI
- 697683292QBASA012U
- Direct Marketing DI
- 06976832920004
- EMDN Code
- W0299 IVD instruments - other
- Device Class
- Class A
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000038310
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Properties
Other properties (10)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- New Device: No