centrifuge
by Shandong Baiou Medical Technology Co., LTD
Ref TDL-600AModel TDL-600A、DL-1000C、TDL-200、TDL-280、TDL-320、TDL-350、TDL-360、TDL-400、TDL-420、 TDL-450、TDL-5000、TDL-360C、TDL-400C、TDL-500C、 TDL-600C、TDL-36B、etc
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 | Number697716824BOCENTRIFUGEQ7 06977168240002 | Date31 Jan 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- Withdrawn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
- Model / Reference
- TDL-600A、DL-1000C、TDL-200、TDL-280、TDL-320、TDL-350、TDL-360、TDL-400、TDL-420、 TDL-450、TDL-5000、TDL-360C、TDL-400C、TDL-500C、 TDL-600C、TDL-36B、etc, TDL-600A
- Primary DI / UDI-DI
- 06977168240002
- Basic UDI-DI
- 697716824BOCENTRIFUGEQ7
- Direct Marketing DI
- 06977168240002
- EMDN Code
- W02069003 Centrifuges
- Device Class
- Class A
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000039886
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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