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IMPROVACUTER® Urine Collection Tube
EUDAMEDFDA UDIClass A (EU MDR)
Ref 471120180;471120182;Model UA Preservative Tube;Urine Culture Preservative Tube
Identity
- Trade Name
- IMPROVACUTER® Urine Collection Tube EUDAMEDUrinalysis Preservative Tube FDA UDI
- Generic Name
- Evacuated urine specimen container IVD, preservative FDA UDI
- Device Name
- Urine Collection Tube EUDAMED
- Model / Reference
- UA Preservative Tube;Urine Culture Preservative Tube EUDAMED471120180;471120182; EUDAMED8ml FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974481837711 EUDAMEDFDA UDI
- Basic UDI-DI
- 697448183009001WG EUDAMEDB-06974481837711 EUDAMED
- FDA Product Code
- FMH FDA UDI
- EMDN Code
- W05010202 URINE COLLECTION, TUBES EUDAMED
- GMDN Term
- Evacuated urine specimen container IVD, preservative FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 864.3250 FDA UDI
- Market of Registration
- Cyprus EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
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
IMPROVACUTER® Urine Collection Tube by Guangzhou Improve Medical Instruments Co., Ltd. — Class A — IVDD, IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 697448183009001WG | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 697448183009001WG | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | 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 (4)
- EUDAMED 91e6d69e-0938-4fe2-b61f-b96b24fcf2ab 61 fields · synced Oct 6, 2026
- EUDAMED d95e97d0-cf94-4773-9fb9-b4bd984d86c9 61 fields · synced May 19, 2026
- FDA UDI 1882ab76-0a8c-4f98-8f2c-42438f91b801 32 fields · synced May 30, 2026
- EUDAMED 91e6d69e-0938-4fe2-b61f-b96b24fcf2ab-1 61 fields · synced Jun 10, 2026