Hunan Biojoint Instrument Co., Ltd
by Hunan Biojoint Instrument Co., Ltd 211 variants
Ref GL-26MCModel TD4-PRP, TDD4-MC, TD4-MR, TDZ5-WS, TDZ6-WS, TDZ5-SX, DL-4M, TDL-4MC, DD4-M, TD4ZA, TD4Z-XB, TD4ZB, TD4A-WS, TGD20, DD5-XK, TD4, TD4-ZF, DL-5M, TG18, TG16-WS, TG18-WS, 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 | Number697836720CentrifugeKV 06978367201443 | Date10 Mar 2025 | 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- Withdrawn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
- TD4-PRP, TDD4-MC, TD4-MR, TDZ5-WS, TDZ6-WS, TDZ5-SX, DL-4M, TDL-4MC, DD4-M, TD4ZA, TD4Z-XB, TD4ZB, TD4A-WS, TGD20, DD5-XK, TD4, TD4-ZF, DL-5M, TG18, TG16-WS, TG18-WS, etc, GL-26MC
- Primary DI / UDI-DI
- 06978367201443
- Basic UDI-DI
- 697836720CentrifugeKV
- Direct Marketing DI
- 06978367201443
- EMDN Code
- W02069003 Centrifuges
- Device Class
- Class A
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000046607
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Hunan Biojoint Instrument Co., Ltd
Properties
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No