ImmunoIVD AB
SE-MF-000034517 · Sweden · Nacka Strand
ImmunoIVD AB is registered in the European database on medical devices as a manufacturer, with 15 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Devices declared under this manufacturer
- SPOT-it TREC & KREC Screening Kit
- SPOT-it TREC & SMN1 Screening Kit
- SPOT-it TREC Screening Kit
- SPOT-it TREC, KREC & SMN1 Screening Kit
Showing 12 of 15 declared devices.
Catalogue references include 12-2015-T, 12-2015-TK, 12-2020-TKS, 12-2020-TS, 4-2015-T, 4-2015-TK.
European nomenclature codes declared: W0106010199.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 15 |
| Country of registration | Sweden |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 15 |
|---|---|
| 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. ImmunoIVD AB was not found in either the U.S. or the Canadian register.