EU → North America Device Access

Prosenso ApS

DK-MF-000043015 · Denmark · Charlottenlund

Prosenso ApS is registered in the European database on medical devices as a manufacturer, with 23 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa23

Most frequent device types declared: EWHAIR14M, EWSHOE35M-UN.

Devices declared under this manufacturer

Showing 12 of 23 declared devices.

Catalogue references include EWBIO35MTG2-L, EWBIO35MTG2-XS, EWBLU35MST2-M, EWBLU35MST2-XL, EWBLU35MST2-XS, EWBLU50MTG15-XL.

European nomenclature codes declared: T01020204, T010201, T0208, T0207.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED23
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 GTIN23
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. Prosenso ApS was not found in either the U.S. or the Canadian register.

Other manufacturers in Denmark

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