Vacuum Blood Collection Tube
by Taizhou Kangwei Medical Instrument Co., Ltd. 18 variants
Ref Plain tubeModel Plain tube; Clot activator tube; Sodium Citrate tube:ESR tube; Lithium Heparin tube; Sodium Heparin tube;Gel&Clot activator tube; Glucose tube;EDTA Tube(EDTA-K2/EDTA-K3/EDTA-Na2); PRPtube(ACD/ACD+ Gel/ Sodium Citrate + Gel/ACD+Gel+Biotin/ACD+Gel+HA/ 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 | Number697826803KWVBCT42 06978268032207 | Date22 Jan 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- Withdrawn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
- Vacuum Blood Collection Tube
- Model / Reference
- Plain tube, Clot activator tube, Sodium Citrate tube:ESR tube, Lithium Heparin tube, Sodium Heparin tube, Gel&Clot activator tube, Glucose tube, EDTA Tube(EDTA-K2/EDTA-K3/EDTA-Na2), PRPtube(ACD/ACD+ Gel/ Sodium Citrate + Gel/ACD+Gel+Biotin/ACD+Gel+HA/ etc
- Primary DI / UDI-DI
- 06978268032207
- Basic UDI-DI
- 697826803KWVBCT42
- EMDN Code
- W050101010201 Blood collection, tubes with additives or serum separator
- Device Class
- Class A
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000045900
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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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