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Vacuum Blood Collection Tube
EUDAMEDClass A (EU MDR)
Ref 6309Model PPT tube, K2-EDTA/gel
Identity
- Device Name
- Vacuum Blood Collection Tube EUDAMED
- Model / Reference
- PPT tube, K2-EDTA/gel EUDAMED6309 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 26953211363090 EUDAMED
- Basic UDI-DI
- 69532113VBCTK2EGel58 EUDAMED
- Unit of Use DI
- 06953211363096 EUDAMED
- EMDN Code
- W050101010201 BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Vacuum Blood Collection Tube by Jiangsu KangJian Medical Apparatus Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69532113VBCTK2EGel58 | Class A | Active |
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Manufacturer
- Manufacturer
- Jiangsu KangJian Medical Apparatus Co., Ltd.
- EUDAMED SRN
- CN-MF-000018938
- Authorised Representative
- Zoustech S.L. ES-AR-000002008
Sources (1)
- EUDAMED 4a9f739c-b04a-4bad-8958-cb45fb6bd933 61 fields · synced Jun 19, 2026