SISTEMAS GENOMICOS. S.L.
ES-MF-000022949 · Spain · PATERNA
SISTEMAS GENOMICOS. S.L. is registered in the European database on medical devices as a manufacturer, with 105 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Most frequent device types declared: Cardio-GeneSGKit DMM 12 reacciones, Cardio-GeneSGKit MCP 12 reacciones, DI-GeneSGKit 12 reacciones, Genesystems© – G-PRECON, LisosomalPeroxisomal-GeneSGKit X 12 reacciones.
Devices declared under this manufacturer
- Cardio-GeneSGKit DMM 12 reacciones
- Cardio-GeneSGKit MCP 12 reacciones
- DI-GeneSGKit 12 reacciones
- DI-GeneSGKit X 12 reacciones
- Genesystems G-NIPT
- Genesystems© – G-PRECON
- LMA-GeneSGKit 12 reacciones
- LisosomalPeroxisomal-GeneSGKit X 12 reacciones
- NIPT-GeneSGKit CE-IVD 12 Reacciones
- Neuro-GeneSGKit Paraplejia 12 reacciones
- OncoFFPE-GeneSGKit Mamma 12 reacciones
- Osteo-GeneSGKit CondroDisplasia 12 reacciones
Showing 12 of 105 declared devices.
Catalogue references include LV3168, LV3461, LV3487, LV3736, LV3870, LV4139.
European nomenclature codes declared: W010699, W0105040519, W0106010399, W02050192.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 105 |
| 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 | 105 |
|---|---|
| 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. SISTEMAS GENOMICOS. S.L. was not found in either the U.S. or the Canadian register.