Disposable Vacuum Blood Tube
by Zhejiang Gongdong Medical Technology Co., Ltd., EUDAMED
Active
Ref GD050SEK3Model EDTA K3+Sodium Fluride
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number6947462411111198ML | Date22 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- EDTA K3+Sodium Fluride, GD050SEK3
- Primary DI / UDI-DI
- 06947462420813
- Basic UDI-DI
- 6947462411111198ML
- EMDN Code
- W050101010201 Blood collection, tubes with additives or serum separator
- 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
Show 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