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Blood Collection Tube
EUDAMEDClass A (EU MDR)
Ref 030010001Model No Additive, Plain Tube, Clot Activator, Gel & Clot Activator, EDTA K2, EDTA K3, EDTA & Gel, Sodium Citrate 9NC, ESR 4NC, Sodium Citrate & Gel, NaF & EDTA, Lithium Heparin, Sodium Heparin, Lithium Heparin & Gel, Sodium Heparin & Gel, ACD, ACD & Gel
Identity
- Trade Name
- Blood Collection Tube EUDAMED
- Device Name
- Blood Collection Tube EUDAMED
- Model / Reference
- No Additive, Plain Tube, Clot Activator, Gel & Clot Activator, EDTA K2, EDTA K3, EDTA & Gel, Sodium Citrate 9NC, ESR 4NC, Sodium Citrate & Gel, NaF & EDTA, Lithium Heparin, Sodium Heparin, Lithium Heparin & Gel, Sodium Heparin & Gel, ACD, ACD & Gel EUDAMED030010001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975473970829 EUDAMED
- Basic UDI-DI
- 697547397030010001YC EUDAMED
- EMDN Code
- W050101010201,W050101010202 EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Malta EUDAMED
Clinical & Handling
Sterile
No
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
Blood Collection Tube by Changsha Renji Medical Equipment 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 | 697547397030010001YC | Class A | Active |
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Manufacturer
- Manufacturer
- Changsha Renji Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000030318
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 334be766-41a0-4866-a939-cee9cfea0d6b 61 fields · synced Oct 6, 2026