EU → North America Device Access

SAM Präzisionstechnik GmbH

DE-MF-000046397 · Germany · Gauting

SAM Präzisionstechnik GmbH is registered in the European database on medical devices as a manufacturer, with 93 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa93

Most frequent device types declared: ATB 394, AXP 100, Artikulator, Bissgabel, Positionierungskappen.

Devices declared under this manufacturer

Showing 12 of 93 declared devices.

Catalogue references include ART 402K, ATB 390K, AXP 101M, AXP 101S, AXP 101XS, AXP 105S.

European nomenclature codes declared: Q0199.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED93
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 GTIN93
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. SAM Präzisionstechnik GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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