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Sistemas Genomicos. S.L.

Active in EUDAMED

Spainfrom SRN EUDAMED SRN ES-MF-000022949

Devices
104
Registrations
EUDAMED

What Sistemas Genomicos. S.L. makes

Sistemas Genómicos S.L. manufactures molecular diagnostic kits for genetic and infectious disease testing, including PCR-based assays for COVID-19 detection (singleplex and multiplex formats), hereditary and neurological disorders (e.g., neuropathies, dementia, and metabolic diseases), and immunodeficiencies. Their product line also covers genetic screening for dyslipidemias, metabolic conditions like MLD, and preconception carrier testing. All kits are designed for laboratory use with specified reaction volumes (e.g., 12 or 48 reactions per kit).

The company’s devices fall under Class C medical devices and In Vitro Diagnostic Medical Devices (IVD) regulated under Annex II List B and General IVD categories, with some products marked CE-IVD. Their products are registered in the EUDAMED database, adhering to European Union regulatory requirements. The manufacturer is based in Spain.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

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Company details

EUDAMED SRN
ES-MF-000022949
EU VAT number
B96779764
EUDAMED status
Active
EUDAMED registered name
SISTEMAS GENOMICOS S.L.
EUDAMED abbreviated name
SISTEMAS GENOMICOS S.L.
Registered address
6, C/ RONDA MARCONI, 46980, PATERNA, Spain
Phone
+34 961 366 150
PRRC contact
ALEJANDRO VILLALBA(public in EUDAMED)