EU → North America Device Access

Ropox a/s

DK-MF-000020145 · Denmark · Næstved

Ropox a/s is registered in the European database on medical devices as a manufacturer, with 115 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa115

Among these devices, 57 are declared active.

Devices declared under this manufacturer

Showing 12 of 115 declared devices.

Catalogue references include 25-20524-8, 40-30406-5, 40-30806-3, 40-40400-1, 40-40436-1, 40-41130-7.

European nomenclature codes declared: Y093399, Y093312, Y181809, V0805030102, V0805038002, Y091299.

United States market access

FDA establishment registerRegistered with FDA
Matched entryROPOX A/S (DK) · FDA 1000206677
Devices in EUDAMED115
Country of registrationDenmark

Device-level evidence

Devices with a numeric GTIN115
Found in the U.S. device database72
Share62.6 %

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. Ropox a/s is registered in the United States but was not found in the Canadian register.

Other manufacturers in Denmark

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