EU → North America Device Access

IVFtech ApS

DK-MF-000025666 · Denmark · Birkerød

IVFtech ApS is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa8

Most frequent device types declared: 12 Tubes, 14 Tubes, 12 Tubes with Battery, 14 Tubes with Battery, 4 Tu, 120, 150, 180, 210, 240, 90, 120, 90, 120, 150, 180, 90, 120, 150, 180 210, 240.

Devices declared under this manufacturer

Catalogue references include 12 Tubes, 14 Tubes, 12 Tubes with Battery, 14 Tubes with Battery, 4 Tu, 120, 150, 180, 210, 240, 90, 120, 90, 120, 150, 180, 90, 120, 150, 180 210, 240, CO2, CO2/N2.

European nomenclature codes declared: Z120499.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED8
Country of registrationDenmark

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

Device-level evidence

Devices with a numeric GTIN8
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. IVFtech ApS was not found in either the U.S. or the Canadian register.

Other manufacturers in Denmark

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