EU → North America Device Access

Puhla Oy

FI-MF-000042691 · Finland · Porvoo

Puhla Oy is registered in the European database on medical devices as a manufacturer, with 32 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa32

Most frequent device types declared: 2041, 8050, 90x115cm.

Devices declared under this manufacturer

Showing 12 of 32 declared devices.

Catalogue references include 2041-HRM-XS, 2041-SNN-L, 2041-SNN-S, 2042-LMU-XS, 2042-SNN-S, 2042-SNN-XL.

European nomenclature codes declared: T0299, Y99, T04010201.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED32
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 GTIN32
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. Puhla Oy was not found in either the U.S. or the Canadian register.

Other manufacturers in Finland

All Finland manufacturers →