EU → North America Device Access

Haltija Group Oy

FI-MF-000006195 · Finland · VANTAA

Haltija Group Oy is registered in the European database on medical devices as a manufacturer, with 21 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa21

Most frequent device types declared: Disposable protection covers for cephalostat, Pikobutton.

Among these devices, 2 are declared active.

Devices declared under this manufacturer

Showing 12 of 21 declared devices.

Catalogue references include MD174318, PB30, PB30WR, PB50, PB50J, PD30.

European nomenclature codes declared: Y2199, Y241203, Q010599.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED21
Country of registrationFinland

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

Device-level evidence

Devices with a numeric GTIN21
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. Haltija Group Oy was not found in either the U.S. or the Canadian register.

Other manufacturers in Finland

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