Centrifuge 5804
Ref 5804 000.528
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 | Number04043758-IA-CEN-001-NQ 04043758017711 | Date24 Jul 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- Withdrawn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
- Device Name
- Centrifuge 5804; Centrifuge 5804R; Centrifuge 5810; Centrifuge 5810R
- Model / Reference
- 5804 000.528
- Primary DI / UDI-DI
- 04043758017711
- Basic UDI-DI
- 04043758-IA-CEN-001-NQ
- Direct Marketing DI
- 04043758017711
- EMDN Code
- W02069003 Centrifuges
- Device Class
- Class A
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000006237
Other devices from Eppendorf SE
Properties
Other properties (11)
- 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
- Surgical Instrument: No
- New Device: No