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Disposable Vacuum Blood Collection Tube
EUDAMEDClass A (EU MDR)
Ref BTSGM07Model K2E/separation gel
Identity
- Trade Name
- Disposable Vacuum Blood Collection Tube EUDAMED
- Device Name
- Disposable Vacuum Blood Collection Tube EUDAMED
- Model / Reference
- K2E/separation gel EUDAMEDBTSGM07 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975754595482 EUDAMED
- Basic UDI-DI
- 697575459089RD 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 | 697575459089RD | 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 1a726f09-2c64-4636-98dd-24ad3bd704a8 61 fields · synced Oct 7, 2026