EU → US Device Access

Lojer Oy

FI-MF-000001639 · Finland · Sastamala

Lojer Oy is registered in the European database on medical devices as a manufacturer, with 199 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa199

Most frequent device types declared: AB Armboards & Arm and Hand Surgery Tables, SS Supports & Straps, CL Clamps, Emergo Emergency and patient trolleys, ScanAfia X hospital beds.

Among these devices, 70 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 registerRegistered with FDA
Matched entryLOJER OY (FI) · FDA 3009307605
Devices in EUDAMED199
Country of registrationFinland

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