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IMPROVACUTER® Evacuated Blood Collection Tube
EUDAMEDClass A (EU MDR)
Ref 645160004;645160005;Model EDTA.K2 Tube;EDTA.K3 Tube;Citrate Tube or Trisodium Citrate Tube;ESR Tube;Sodium Heparin Tube;Lithium Heparin Tube;Glucose Tube;Fluoride/Oxalate Tube ;Gel & EDTA.K2 Tube;Gel & Lithium Heparin Tube;Gel & Sodium Heparin Tube
Identity
- Trade Name
- IMPROVACUTER® Evacuated Blood Collection Tube EUDAMED
- Device Name
- Evacuated Blood Collection Tube EUDAMED
- Model / Reference
- EDTA.K2 Tube;EDTA.K3 Tube;Citrate Tube or Trisodium Citrate Tube;ESR Tube;Sodium Heparin Tube;Lithium Heparin Tube;Glucose Tube;Fluoride/Oxalate Tube ;Gel & EDTA.K2 Tube;Gel & Lithium Heparin Tube;Gel & Sodium Heparin Tube EUDAMED645160004;645160005; EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974481833805 EUDAMED
- Basic UDI-DI
- 697448183007003W6 EUDAMEDB-06974481833805 EUDAMED
- EMDN Code
- W050101010201 BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR EUDAMED
Classification
- Device Class
- Class A EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Cyprus 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
IMPROVACUTER® Evacuated Blood Collection Tube by Guangzhou Improve Medical Instruments Co., Ltd. — Class A — IVDD, IVDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 697448183007003W6 | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 697448183007003W6 | Class A | Active |
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Manufacturer
- Manufacturer
- Guangzhou Improve Medical Instruments Co., Ltd
- EUDAMED SRN
- CN-MF-000006536
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED 21c202ac-4544-4cfb-aadb-6596e0973e00 61 fields · synced Oct 6, 2026
- EUDAMED df7d0a96-e4d2-4426-abff-fd3816021749 61 fields · synced May 19, 2026
- EUDAMED 21c202ac-4544-4cfb-aadb-6596e0973e00-1 61 fields · synced Jun 10, 2026