EU → North America Device Access

2cureX A/S

DK-MF-000036335 · Denmark · Copenhagen

2cureX A/S is registered in the European database on medical devices as a manufacturer, with 13 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Most frequent device types declared: 2CX-SCK-01, 2cx-CRCEXP, 2cx-CRCEXT, 2cx-CRCMCK-01, 2cx-CRCSTA.

Devices declared under this manufacturer

Showing 12 of 13 declared devices.

Catalogue references include 2CX-CRCEXP-01, 2CX-CRCEXT-01, 2CX-INC-01, 2cx-CRCEXT, 2cx-CRCMCK, 2cx-CRCSTA.

European nomenclature codes declared: W02050285, W01020899, W02069092, W0102030299, W01029099, W05020102.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED13
Country of registrationDenmark

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

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. 2cureX A/S was not found in either the U.S. or the Canadian register.

Other manufacturers in Denmark

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