EU → North America Device Access

Saalmann medical GmbH & Co. KG

DE-MF-000010552 · Germany · Bad Oeynhausen

Saalmann medical GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 13 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa13

Among these devices, 6 are declared active.

Devices declared under this manufacturer

Showing 12 of 13 declared devices.

Catalogue references include 07-01-000-01, 07-01-000-07, 07-01-007-02, 07-01-028-01, 07-01-028-03, 07-01-028-04.

European nomenclature codes declared: Z120604, Z12040202.

United States market access

FDA establishment registerRegistered with FDA
Matched entrySAALMANN MEDICAL GMBH & CO. KG (DE) · FDA 3016463808
Devices in EUDAMED13
Country of registrationGermany

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: United States only. Saalmann medical GmbH & Co. KG is registered in the United States but was not found in the Canadian register.

Other manufacturers in Germany

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