BlueDiverDot Polymyositis/Scleroderma8 IgG
by D-tek s.a. Belgium EUDAMED
Ref PMS8DIV-24Model BlueDiverDot Polymyositis/Scleroderma, 542502368BDDPMSCLLT EMDN W0102100108
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | Number542502368BDDPMSCLLT | Date18 Nov 2025 | StatusActive |
| European Union | CE/IVDR | Number542502368BDDPMSCLLT | Date18 Nov 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD, CE/IVDR Active
Specification
- Trade Name
- BlueDiverDot Polymyositis/Scleroderma8 IgGBlueDiver Dot Polymyositis/Scleroderma8 IgG
- Device Name
- BlueDiver Dot Overlap PM/SCL
- Model / Reference
- BlueDiverDot Polymyositis/Scleroderma, PMS8DIV-24, 542502368BDDPMSCLLT
- Primary DI / UDI-DI
- 05425023681589
- Basic UDI-DI
- 542502368BDDPMSCLLT, B-05425023681589
- Direct Marketing DI
- 05425023681589
- EMDN Code
- W0102100108 Jo-1
- Device Class
- Class BClass IVD General
- 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 fc078949-7622-4107-ba43-5bc37a1c795e
- EUDAMED 05425023681589|B-05425023681589