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Bio-Gram Diagnostics GmbH

Germany DE-MF-000032559 Last updated 23 Oct 2026

Devices
22
Registries
EUDAMEDGUDIDFDA
FDA recalls
0

Catalogue22

About

Since its establishment in 2019, Bio-Gram has been at the forefront of providing cutting-edge In-Vitro-Diagnostic solutions, specifically focused on smear staining and sample preparation. With an unwavering commitment to shaping the future of diagnostics through uncompromisingly high-quality systems, Bio-Gram has consistently set new standards in the industry by developing and manufacturing innovative and reliable next-generation Diagnostic Solutions, proudly bearing the mark of "Made in Germany."

From the manufacturer's own website. Source

What Bio-Gram Diagnostics GmbH makes

Bio-Gram Diagnostics GmbH manufactures automated and manual staining systems for cytological and hematological smear preparations, including the Etzel I, Gram-Polychrome, MGG, Wright, Lugol’s, and Giemsa JetDye-AF kits, as well as pH-buffered solutions like JetBuffer and FixOstar. Their portfolio also includes disposable microscope slides designed for laboratory use in diagnostic workflows.

All listed devices fall under EU Class A in vitro diagnostic medical devices and are registered in the EU’s eudamed database. The company is based in Germany and adheres to relevant EU regulatory requirements for diagnostic products.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
Germany
Address
12, Altrheinstraße , Worms, Germany
Phone
+49 621 490 844 50
PRRC contact
Bayram Cucu
EUDAMED SRN
DE-MF-000032559
FDA FEI number
3044854712
DUNS number
343065489