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IMPROVACUTER® Tourniquet
EUDAMEDFDA UDIClass I (EU MDR)
Ref 5710A0100;5710A0100;5710A1400Model For Adult;For Kid
Identity
- Trade Name
- IMPROVACUTER® Tourniquet EUDAMEDFDA UDI
- Generic Name
- Venous tourniquet, single-use FDA UDI
- Device Name
- Tourniquet EUDAMED
- Model / Reference
- For Adult;For Kid EUDAMED5710A0100;5710A0100;5710A1400 EUDAMEDFor Kid FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974481839555 EUDAMEDFDA UDI
- Basic UDI-DI
- 697448183005001VL EUDAMED
- FDA Product Code
- GAX FDA UDI
- EMDN Code
- V9003 TOURNIQUETS EUDAMED
- GMDN Term
- Venous tourniquet, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.5900 FDA UDI
- Market of Registration
- Cyprus EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Limb tourniquet, manual, reusable
IMPROVACUTER® Tourniquet by Guangzhou Improve Medical Instruments Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Also classified as Limb tourniquet, manual, reusable.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697448183005001VL | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 528f43b8-7367-49a9-a1ed-20f0018b09dd 61 fields · synced Jul 25, 2026
- FDA UDI 74b98214-1166-4e93-b90f-a5789252cabb 32 fields · synced May 30, 2026
- EUDAMED 528f43b8-7367-49a9-a1ed-20f0018b09dd-1 61 fields · synced Jun 10, 2026