Single-use Container for Human Venous Blood Specimen Collection
by Hebei Kangning Medical Equipment Co., Ltd 6 variants
Ref Clot Activator TubesModel Plain tube：1ml、2ml 、3ml、4ml 、5ml、6ml、7 ml、8ml 、9ml、10ml Clot activator Tube：1ml、2ml、 3ml、 4ml、 5ml、 6ml、7 ml、8ml 、9ml、10ml 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 | Number69333845DVBSCC001J7 06933384500016 | Date21 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- Withdrawn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
- Single-use Container for Human Venous Blood Specimen Collection
- Model / Reference
- Plain tube：1ml、2ml 、3ml、4ml 、5ml、6ml、7 ml、8ml 、9ml、10ml Clot activator Tube：1ml、2ml、 3ml、 4ml、 5ml、 6ml、7 ml、8ml 、9ml、10ml etc, Clot Activator Tubes
- Primary DI / UDI-DI
- 06933384500016
- Basic UDI-DI
- 69333845DVBSCC001J7
- 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-000047002
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Hebei Kangning Medical Equipment Co., Ltd
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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