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
| other | 105 |
|---|
Most frequent device types declared: COVID-19 Multiplex OneStep PCR Lyo-H CE-IVD. Placa 96 Reacciones., Genesystems© – G-PRECON, NIPT-GeneSGKit, OncoFFPE-GeneSGKit Mamma 12 reacciones, Cardio-GeneSGKit DMM 12 reacciones.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 105 |
| Country of registration | Spain |
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.