BlueDot Celiac IgG
by D-tek s.a. Belgium EUDAMED
Ref ENDG-24Model BlueDot, BlueDot Celiac
EMDN W0102100602
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | NumberB-05425023680438 | Date9 Aug 2024 | StatusActive |
| European Union | CE/IVDD | NumberB-05425023680438 | Date9 Aug 2024 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR, CE/IVDD Active
Specification
- Model / Reference
- BlueDot, ENDG-24, BlueDot Celiac
- Primary DI / UDI-DI
- 05425023680438
- Basic UDI-DI
- B-05425023680438, 542502368BDCELIACE4
- Direct Marketing DI
- 05425023680438
- EMDN Code
- W0102100602 Tissue transglutaminase/ gliadin antibodies combitest
- Device Class
- Class IVD GeneralClass B
- Market of Registration
- Belgium
Manufacturer details
- EUDAMED SRN
- BE-MF-000024530
Other devices from D-tek s.a.
Properties & raw data
Show properties, registry sources and raw records
Other properties (8)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (2)
- EUDAMED a0ad9f01-304d-4975-897a-646e364d03c1
- EUDAMED 05425023680438|542502368BDCELIACE4