Microcentrifuge
Ref 91300
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 | Number697286012913002Y | Date29 May 2024 | 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- Withdrawn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
- Trade Name
- MicrocentrifugeRefrigerated microcentrifugeHigh-Speed Benchtop Refrigerated Centrifuge
- Device Name
- Microcentrifuge/Refrigerated microcentrifuge/High-Speed Benchtop Refrigerated Centrifuge
- Model / Reference
- 91300
- Primary DI / UDI-DI
- 06972860129136, 06972860120096, 06972860120102, 06972860120119
- Basic UDI-DI
- 697286012913002Y
- Direct Marketing DI
- 06972860129136069728601200960697286012010206972860120119
- EMDN Code
- W02069003, W02069005
- Device Class
- Class A
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000042234
- Authorised representative
- WISELINK MEDICAL, S.L.U. ES-AR-000052118
Other devices from RWD Life Science Co., Ltd.
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