EU → North America Device Access

Oscilla A/S

DK-MF-000002784 · Denmark · Aarhus

Oscilla A/S is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa9

Most frequent device types declared: ATM4, SW01.

Among these devices, 8 are declared active, 1 with a measuring function.

Devices declared under this manufacturer

Catalogue references include 1218, 1230, 1232, 1233, 1234, 1237.

European nomenclature codes declared: Z121401, V92.

United States market access

FDA establishment registerRegistered with FDA
Matched entryOSCILLA A/S (DK) · FDA 3027357482
Devices in EUDAMED9
Country of registrationDenmark

Device-level evidence

Devices with a numeric GTIN9
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: United States only. Oscilla A/S is registered in the United States but was not found in the Canadian register.

Other manufacturers in Denmark

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