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Disposable Vacuum Blood Collection Tube
EUDAMEDClass A (EU MDR)
Ref BTSPA04Model No Additive
Identity
- Trade Name
- Disposable Vacuum Blood Collection Tube EUDAMED
- Device Name
- Disposable Vacuum Blood Collection Tube EUDAMED
- Model / Reference
- No Additive EUDAMEDBTSPA04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16975754591221 EUDAMED
- Basic UDI-DI
- 697575459077R6 EUDAMED
- EMDN Code
- W050101010202 BLOOD COLLECTION, TUBES WITHOUT 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 | 697575459077R6 | 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 e163155f-5447-4f6e-a110-95e22d310f7a 61 fields · synced Jun 19, 2026