EU → North America Device Access

Blazejewski MEDI-TECH GmbH

DE-MF-000005467 · Germany · Sexau

Blazejewski MEDI-TECH GmbH is registered in the European database on medical devices as a manufacturer, with 323 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa323

Among these devices, 323 are declared reusable.

Catalogue references include 9AAE-1020, 9ABA-1026, 9ADG-1014, 9AEA-1039, 9AGA-1041, 9AGG-1004.

European nomenclature codes declared: Z121301, Z12020701, Z12020705, Z12021101, Z12020713, Z12029009.

United States market access

FDA establishment registerRegistered with FDA
Matched entryBLAZEJEWSKI MEDI-TECH GMBH (DE) · FDA 9710457
Devices in EUDAMED323
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. Blazejewski MEDI-TECH GmbH is registered in the United States but was not found in the Canadian register.

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