EU → US Device Access

BILI BIKE SP. Z O.O.

PL-MF-000053517 · Poland · GORZÓW WIELKOPOLSKI

BILI BIKE SP. Z O.O. is registered in the European database on medical devices as a manufacturer, with 50 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa50

Most frequent device types declared: Velmor 4 / Velmor 4 MAX, Velmor 3 / Velmor 3 MAX, Mobilio / Mobilio MAX.

Among these devices, 50 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 EUDAMED50
Country of registrationPoland
⚠️ 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.

Other manufacturers in Poland

All Poland manufacturers →