EU → North America Device Access

Sairex Ky

FI-MF-000016116 · Finland · Kuopio

Sairex Ky is registered in the European database on medical devices as a manufacturer, with 10 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa10

Most frequent device types declared: 1565 / 1566 / 1566X, 2733, 3187a / 3188a / 3189a / 3190a, 4110 / 4120 / 4115 / 4128 / 4126 / 4127, 4160 / 4162 / 4175 / 4180.

Devices declared under this manufacturer

Catalogue references include 3187a, 4110, 4160, 4200, 4207, 4265.

European nomenclature codes declared: V08068099, Y090699, Z12019010, V0811, Y180980, V08030102.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED10
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 GTIN10
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. Sairex Ky was not found in either the U.S. or the Canadian register.

Other manufacturers in Finland

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