IGENOMIX SPAIN LAB S.L UNIPERSONAL
ES-MF-000029287 · Spain · Paterna
IGENOMIX SPAIN LAB S.L UNIPERSONAL is registered in the European database on medical devices as a manufacturer, with 12 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Devices declared under this manufacturer
- EMBRACE Kit
- Endometrio Kit
- Kit Blood 1
- Kit Blood 2
- Kit Buccal swab CR1
- Kit Buccal swab CR2
- Kit Buccal swab SR2
- Kit POC I
- Kit SAT
- Kit Saliva 1
- Kit Saliva 2
- PGT Kit
Catalogue references include P2000, P2007, P2008, P2011, P2013, P2015.
European nomenclature codes declared: W05019099.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 12 |
| Country of registration | Spain |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 12 |
|---|---|
| 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. IGENOMIX SPAIN LAB S.L UNIPERSONAL was not found in either the U.S. or the Canadian register.