BIOTICAL HEALTH S.L.U
ES-MF-000018831 · Spain · SAN FERNANDO DE HENARES
BIOTICAL HEALTH S.L.U is registered in the European database on medical devices as a manufacturer, with 117 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| other | 117 |
|---|
Most frequent device types declared: biotical C. difficile Toxin B Positive control (1u) / , biotical Salmonella typhi Card (+PC) / , biotical C. difficile GDH Positive control (30u) / , biotical Giardia Positive control (30u) / , biotical Campylobacter Card (+PC) / .
Among these devices, 3 are declared sterile.
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 | 117 |
| 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.