EU → North America Device Access

Cortex Technology Aps

DK-MF-000002984 · Denmark · Aalborg Ø

Cortex Technology Aps is registered in the European database on medical devices as a manufacturer, with 34 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa34

Among these devices, 4 are declared reusable, 4 active.

Devices declared under this manufacturer

Showing 12 of 34 declared devices.

Catalogue references include COS D, CP 1 mm, CP SP, E0200119, LEXAN, OS BS BL.

European nomenclature codes declared: Z120102.

United States market access

FDA establishment registerRegistered with FDA
Matched entryCORTEX TECHNOLOGY APS (DK) · FDA 9613249
Devices in EUDAMED34
Country of registrationDenmark

Device-level evidence

Devices with a numeric GTIN34
Found in the U.S. device database2
Share5.9 %

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. Cortex Technology Aps is registered in the United States but was not found in the Canadian register.

Notified body certificates

CertificateStatusExpiry
G15 136360 0001issued2030-01-20
C543644issued2030-01-20

Other manufacturers in Denmark

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