EU → US Device Access

Lasinpuhaltamo Hakola Oy

FI-MF-000012479 · Finland · Kiviniemi

Lasinpuhaltamo Hakola Oy is registered in the European database on medical devices as a manufacturer, with 44 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa44

Most frequent device types declared: Imukärki 2,0-2,5 x 60 mm (AR-Lasia), Imukärki 2,0-2,5 x 55 mm (AR-Lasia), Imukärki 2,0 x 90 mm (AR-Lasia), Imukärki 3,5 x 90 mm (AR-Lasia), Imukärki 1,0 x 100 mm (AR-Lasia).

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 EUDAMED44
Country of registrationFinland
⚠️ 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.

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