EU → North America Device Access

Pressalit A/S

DK-MF-000001767 · Denmark · Ry

Pressalit A/S is registered in the European database on medical devices as a manufacturer, with 603 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIa603

Most frequent device types declared: R10, R11, R18, R37, R38, R48.

Devices declared under this manufacturer

Showing 12 of 603 declared devices.

Catalogue references include R1837000-29, R372585000, R7134035, R7434277, R7454000, R7634108.

European nomenclature codes declared: Y181809, Y093312, Y093303, Y181803, Y093399, Y181899.

United States market access

FDA establishment registerSimilar name found — unverified
Matched entryPRESSALIT (DK) · FDA 3003947878
Devices in EUDAMED603
Country of registrationDenmark

⚠️ A similar name exists; we do not assert it is the same company — why.

Device-level evidence

Devices with a numeric GTIN603
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.

Other manufacturers in Denmark

All Denmark manufacturers →