EU → North America Device Access

Sutter Medizintechnik GmbH

DE-MF-000005544 · Germany · Emmendingen

Sutter Medizintechnik GmbH is registered in the European database on medical devices as a manufacturer, with 723 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb603
Class IIa120

Among these devices, 44 are declared sterile, 679 reusable, 723 active.

Catalogue references include 370140SG, 700921S, 780148SGS, 780199SLS, 782396SL, 783191SGS.

European nomenclature codes declared: L180401, Z12010980, K0201010601, S010401, K0201010301, Z12010902.

United States market access

FDA establishment registerRegistered with FDA
Matched entrySUTTER MEDIZINTECHNIK GMBH (DE) · FDA 8044091
Devices in EUDAMED723
Country of registrationGermany

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. Sutter Medizintechnik GmbH is registered in the United States but was not found in the Canadian register.

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