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IMPROVACUTER® Evacuated Blood Collection Tube

EUDAMEDFDA 510(k)

Class A (EU MDR)

Ref 622020202;Model Clot Activator Tube;Gel & Clot Activator Tube

by Guangzhou Improve Medical Instruments Co., Ltd

Identity

Trade Name
IMPROVACUTER® Evacuated Blood Collection Tube EUDAMED
Device Name
Evacuated Blood Collection Tube EUDAMED
Model / Reference
Clot Activator Tube;Gel & Clot Activator Tube EUDAMED
622020202; EUDAMED

Identifiers

Primary DI / UDI-DI
06974481831443 EUDAMED
Basic UDI-DI
697448183007002W4 EUDAMED
B-06974481831443 EUDAMED
EMDN Code
W050101010201 BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR EUDAMED

Classification

Device Class
Class A EUDAMED
Class 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

No

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 — FDA_510K, IVDR, IVDD — listed in EUDAMED, FDA…

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/IVDR

European Union Active

CE/IVDD

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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 40b0b433-ec53-43c0-a7e8-91595cbef282 61 fields · synced Oct 6, 2026
  • EUDAMED 8fd67fab-e64e-4d58-a525-ad694c3fcce2 61 fields · synced May 17, 2026
  • FDA 510(k) K093910 1 fields · synced May 18, 2026