Disposable Urine Collection Tube
by Zhejiang Gongdong Medical Technology Co., Ltd., EUDAMED
Active
Ref GD040UBFBModel boric acid + sodium formate + sodium borate
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number6947462411111157M6 | Date17 Mar 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Disposable Urine Collection Tube
- Model / Reference
- boric acid + sodium formate + sodium borate, GD040UBFB
- Primary DI / UDI-DI
- 06947462401744
- Basic UDI-DI
- 6947462411111157M6
- EMDN Code
- W05010202 Urine collection, tubes
- Device Class
- Class A
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000005694
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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Properties
Other properties (10)
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No