Vacuum Blood Collection Tube
EUDAMEDClass A (EU MDR)
Identity
- Device Name
- Vacuum Blood Collection Tube EUDAMED
- Model / Reference
- PPT tube, K3-EDTA/gel EUDAMED6327 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 26953211363274 EUDAMED
- Basic UDI-DI
- 69532113VBCTK3EGel5K EUDAMED
- Unit of Use DI
- 06953211363270 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
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
Vacuum Blood Collection Tube is a medical device designed for safe and efficient blood collection, making it an essential tool in various clinical settings. This implantable device uses a proprietary technology to capture blood samples from patients with minimal discomfort, ensuring accurate and reliable results. With its sterile design and easy-to-use interface, this device streamlines laboratory processes while maintaining high standards of quality and patient safety.
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69532113VBCTK3EGel5K | 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 cbe00d63-03a1-4ea2-9867-066dacf1f31a 61 fields · synced Jun 22, 2026