EU → North America Device Access

Betterguards Technology GmbH

DE-MF-000028712 · Germany · Hennigsdorf

Betterguards Technology GmbH is registered in the European database on medical devices as a manufacturer, with 142 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa142

Most frequent device types declared: The BetterGuard, The BetterGuard 2.0, The BetterGuard 3.0, The BetterG.

Devices declared under this manufacturer

Showing 12 of 142 declared devices.

Catalogue references include 700341, 710211, 710221, 710351, 710420, 710921.

European nomenclature codes declared: Y061299.

United States market access

FDA establishment registerRegistered with FDA
Matched entryBETTERGUARDS TECHNOLOGY GMBH (DE) · FDA 3027285106
Devices in EUDAMED142
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN142
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. Betterguards Technology GmbH is registered in the United States but was not found in the Canadian register.

Other manufacturers in Germany

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