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IMPROVACUTER® Urine Collection Tube
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 471121192;471120190;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 EUDAMED471121192;471120190; EUDAMED9ml FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974481839616 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06974481839616 EUDAMED697448183009001WG 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 IVD General EUDAMEDClass A 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 IVD General — IVDR, IVDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06974481839616 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06974481839616 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | 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 cd3af91f-54aa-4a5d-a6bf-5e71ea51de12 61 fields · synced Oct 6, 2026
- EUDAMED 94447edf-63b6-4afd-bae1-b009e8964adc 61 fields · synced May 19, 2026
- FDA UDI 892e7d11-e6d3-490c-9bc8-dd1c434dc7e9 32 fields · synced May 30, 2026
- EUDAMED cd3af91f-54aa-4a5d-a6bf-5e71ea51de12-1 61 fields · synced Jun 9, 2026