D-tek s.a.
BE-MF-000024530 · Belgium · Mons
D-tek s.a. is registered in the European database on medical devices as a manufacturer, with 237 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Most frequent device types declared: 542502368BDDANAYE, 542502368BDDLIVERKL, BlueDiver Dot, BlueDiver Quantrix, BlueDiverDot ANCA.
Devices declared under this manufacturer
- ANA 12 Ag R Dot for BDI
- ANA Granular 12 Ag IgG Dot for BDI
- ANA PROFILE 25 Ag DOT for BDI
- BlueDiver Dot Liver7 IgG
- BlueDiver Dot PRL12 IgG
- BlueDiverDot ANCA+GBM IgG
- BlueDiverDot Liver10 IgG
- BlueDot Myositis12 SAE IgG
- DiaSpot ANA8 IgG
- Myositis Profile 12 Ag OJ Dot for BDI
- NDH Chromatin + DFS70 Dot for BDI
- NDH Chromatin Dot
Showing 12 of 237 declared devices.
Catalogue references include AD ANA25DBD, AD ANAGR12DBD, AD GADBD, ANCAGDIV-24, KAPDTANA8, LI10DIV-24.
European nomenclature codes declared: W0102100101, W0102100108, W0102100703, W0102100602, W0102100107, W0102100110.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 237 |
| Country of registration | Belgium |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 237 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. D-tek s.a. was not found in either the U.S. or the Canadian register.