EU → North America Device Access

CODAN Medical ApS

DK-MF-000001269 · Denmark · Roedby

CODAN Medical ApS is registered in the European database on medical devices as a manufacturer, with 86 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa86

Most frequent device types declared: 62.1002, 62.1256.

Among these devices, 50 are declared sterile, 86 with a measuring function.

Devices declared under this manufacturer

Showing 12 of 86 declared devices.

Catalogue references include 62.1255, 62.1900, 62.5202, 62.6950, 62.7201, 62.7709.

European nomenclature codes declared: A020199, A02010699, A020109.

United States market access

FDA establishment registerRegistered with FDA
Matched entryCODAN MEDICAL APS. (DK) · FDA 8021538
Devices in EUDAMED86
Country of registrationDenmark

Device-level evidence

Devices with a numeric GTIN86
Found in the U.S. device database4
Share4.7 %

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. CODAN Medical ApS is registered in the United States but was not found in the Canadian register.

Other manufacturers in Denmark

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