Vacuum Blood Collection Tube
by Zhejiang Kangshi Medical Devices Co., Ltd EUDAMED
Active
Ref KS-FXModel KS-K2E/SST
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69490661TUBE00128 | Date13 Feb 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Vacuum Blood Collection Tube
- Model / Reference
- KS-K2E/SST, KS-FX
- Primary DI / UDI-DI
- 06949066106094
- Basic UDI-DI
- 69490661TUBE00128
- EMDN Code
- W050101010201 Blood collection, tubes with additives or serum separator
- Device Class
- Class A
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000047239
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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Properties
Show properties
Other properties (9)
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No