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Disposable Vacuum Blood Collection Tube
EUDAMEDClass A (EU MDR)
Ref BTSPF35Model Sodium heparin/separation gel
Identity
- Trade Name
- Disposable Vacuum Blood Collection Tube EUDAMED
- Device Name
- Disposable Vacuum Blood Collection Tube EUDAMED
- Model / Reference
- Sodium heparin/separation gel EUDAMEDBTSPF35 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 26975754593017 EUDAMED
- Basic UDI-DI
- 697575459082QX EUDAMED
- EMDN Code
- W050101010201 BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Ireland 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Disposable Vacuum Blood Collection Tube by Henan Tuoren Medical Technology 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 | 697575459082QX | Class A | Active |
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Manufacturer
- Manufacturer
- Henan Tuoren Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000017165
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED c457ae86-80d3-4653-9d17-289421f53df1 61 fields · synced Jun 19, 2026