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IMPROVACUTER® Urine Collection Tube
EUDAMEDFDA UDIClass A (EU MDR)
Ref 470031182;470031180;Model UA No Additive Tube
Identity
- Trade Name
- IMPROVACUTER® Urine Collection Tube EUDAMEDUrine Collection Tube FDA UDI
- Generic Name
- Evacuated urine specimen container IVD, no additive FDA UDI
- Device Name
- Urine Collection Tube EUDAMED8mL FDA UDI
- Model / Reference
- UA No Additive Tube EUDAMED470031182;470031180; EUDAMEDUrinalysis No Additive Tube FDA UDI
- Description
- 8mL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974481833492 EUDAMEDFDA UDI
- Basic UDI-DI
- 697448183009002WJ EUDAMEDB-06974481833492 EUDAMED
- FDA Product Code
- FMH FDA UDI
- EMDN Code
- W05010202 URINE COLLECTION, TUBES EUDAMED
- GMDN Term
- Evacuated urine specimen container IVD, no additive 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
Yes
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 | 697448183009002WJ | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 697448183009002WJ | 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 dd33bd1d-b624-47a1-b2f7-7158cb7b6e74 61 fields · synced Jul 11, 2026
- EUDAMED 6d22736e-c408-4731-a6f6-295b28ae1d1b 61 fields · synced May 19, 2026
- FDA UDI 60c3f9cf-d42c-44d0-9a52-5f1402a6d49f 33 fields · synced May 30, 2026
- EUDAMED dd33bd1d-b624-47a1-b2f7-7158cb7b6e74-1 61 fields · synced Jun 9, 2026