EU → North America Device Access

a1 medical GmbH

DE-MF-000006489 · Germany · Tuttlingen

a1 medical GmbH is registered in the European database on medical devices as a manufacturer, with 23 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa23

Among these devices, 23 are declared reusable.

Devices declared under this manufacturer

Showing 12 of 23 declared devices.

Catalogue references include C-0720, C-0750, ES-0140, ES-0921, F-4440, F-4633.

European nomenclature codes declared: L170201, L170102, L1799, Q02010101, L170499, L010413.

United States market access

FDA establishment registerRegistered with FDA
Matched entryA1 MEDICAL GMBH (DE) · FDA 3009504366
Devices in EUDAMED23
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN23
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. a1 medical GmbH is registered in the United States but was not found in the Canadian register.

Other manufacturers in Germany

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