D-Dimer Test Kit (Immunofluorescence Method)
by Jiangsu Konsung Medical Technology Co., Ltd. EUDAMED
Active
Ref CDD-402F
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06975132462917 | Date26 May 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Specification
- Device Name
- D-Dimer Test Kit (Immunofluorescence Method)
- Model / Reference
- CDD-402F
- Primary DI / UDI-DI
- 06975132462917
- Basic UDI-DI
- B-06975132462917
- EMDN Code
- W0103020803 D-dimer - rt & poc
- Device Class
- Class IVD General
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000004533
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
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Properties
Show properties
Other properties (6)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No