EU → North America 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: 4040X electric examination tables, 6700 Geriatric Recliner Chairs, AB Armboards & Arm and Hand Surgery Tables, CL Clamps, Capre F electric treatment tables.

Among these devices, 70 are declared active.

Devices declared under this manufacturer

Showing 12 of 199 declared devices.

Catalogue references include AB5012, CL2021, CL2122, Capre M4H, Delta Standard DS4H, Delta Standard DS5H.

European nomenclature codes declared: V0899, Z12011280, Z12011299, V08060101, V08050103, T020199.

United States market access

FDA establishment registerRegistered with FDA
Matched entryLOJER OY (FI) · FDA 3009307605
Devices in EUDAMED199
Country of registrationFinland

Device-level evidence

Devices with a numeric GTIN199
Found in the U.S. device database10
Share5.0 %

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: United States only. Lojer Oy is registered in the United States but was not found in the Canadian register.

Other manufacturers in Finland

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