EU → US Device Access

GymnaUniphy N.V.

BE-MF-000001786 · Belgium · Bilzen

GymnaUniphy N.V. 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

Class IIa12

Most frequent device types declared: Device for multiple non-invasive electrophysical modalities, electric treatment table, Devices for electrolysis and dry needling, Device for ultrasound therapy.

Among these devices, 12 are declared active.

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 registerNot found in the FDA register
Devices in EUDAMED12
Country of registrationBelgium
⚠️ 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.

Notified body certificates

CertificateStatusExpiry
2257802CE01supplemented2028-10-01

Other manufacturers in Belgium

All Belgium manufacturers →