EU → North America Device Access

Fischer ANalysen Instrumente GmbH

DE-MF-000011513 · Germany · Leipzig

Fischer ANalysen Instrumente GmbH is registered in the European database on medical devices as a manufacturer, with 11 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa5

Among these devices, 1 are declared active.

Devices declared under this manufacturer

Catalogue references include DOB-B-00, DOB-E-00, F201-VP-06a, F301-GA-00, F302-SO-01, HV-Lacto-CG.

European nomenclature codes declared: W0580, Z12159006, W05019099, Z12159085, R9001, Z12159080.

United States market access

FDA establishment registerRegistered with FDA
Matched entryFISCHER ANALYSEN INSTRUMENTE GMBH (DE) · FDA 3010837197
Devices in EUDAMED11
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. Fischer ANalysen Instrumente GmbH is registered in the United States but was not found in the Canadian register.

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