EU → North America Device Access

ExSeed Health ApS

DK-MF-000025034 · Denmark · København S

ExSeed Health ApS is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Most frequent device types declared: ExSeed CASA Lite Human Semen Analyzer, ExSeed Home Sperm Test Kit (10), ExSeed Home Sperm Test Kit (2), ExSeed Home Sperm Test Kit (5), ExSeed Home Sperm Test Refil Kit (5).

Devices declared under this manufacturer

Catalogue references include EH-1001-01, EH-1001-05, EH-1001-05-2, EH-1001-05-5, EH-1001-10, EH-3001-01.

European nomenclature codes declared: W02020199.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED6
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 GTIN6
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. ExSeed Health ApS was not found in either the U.S. or the Canadian register.

Other manufacturers in Denmark

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