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BIOZOL Diagnostica Vertrieb GmbH

DE-MF-000043808 · Germany · Hamburg

BIOZOL Diagnostica Vertrieb GmbH is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa4

Most frequent device types declared: 4m, DIA-H09.

Among these devices, 2 are declared active.

Devices declared under this manufacturer

Catalogue references include 5194000020, DNA-DIA-H09, EPE-5191000015, EPE-5196000021, EPE-5196000048.

European nomenclature codes declared: U08020399, W0102010113, U08020380.

United States market access

FDA establishment registerRegistered with FDA
Matched entryBIOZOL DIAGNOSTICA VERTRIEB GMBH (DE) · FDA 3016505000
Devices in EUDAMED5
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN5
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. BIOZOL Diagnostica Vertrieb GmbH is registered in the United States but was not found in the Canadian register.

Other manufacturers in Germany

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