EU → North America Device Access

ERKA Medizintechnik GmbH & Co. KG

DE-MF-000051421 · Germany · Bad Tölz

ERKA Medizintechnik GmbH & Co. KG 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

Class IIa13

Most frequent device types declared: ERKA Aneroid Blood Pressure Monitor Series.

Among these devices, 13 are declared with a measuring function.

Devices declared under this manufacturer

Showing 12 of 13 declared devices.

Catalogue references include 201.00000.7290, 205.00000.7290, 214.00000.7290, 228.00000.7290, 230.00000.7290, 285.00000.7290.

European nomenclature codes declared: C9006.

United States market access

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

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

Device-level evidence

Devices with a numeric GTIN13
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: Neither register. ERKA Medizintechnik GmbH & Co. KG was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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