EU → North America 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: Mobilio / Mobilio MAX, Velmor 3 / Velmor 3 MAX, Velmor 4 / Velmor 4 MAX.

Among these devices, 50 are declared active.

Devices declared under this manufacturer

Showing 12 of 50 declared devices.

Catalogue references include BBSKUTER1880, BBSKUTER1881, BBSKUTER1898, BBSKUTER1903, BBSKUTER1915, BBSKUTER1917.

European nomenclature codes declared: Y122124.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED50
Country of registrationPoland

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN50
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: Neither register. BILI BIKE SP. Z O.O. was not found in either the U.S. or the Canadian register.

Other manufacturers in Poland

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