BioMaxima Spółka Akcyjna

BioMaxima Spółka Akcyjna specializes in microbiological culture media and reagents. Their products include selective and differential agar plates (such as MacConkey No 2, Kligler Iron Agar, and Chromogenic E. coli 0157 Agar), broths (like Trypticasein Soy Broth and Todd Hewitt Broth), and specialized agars (including Schaedler Agar for anaerobic cultures and Chromogenic URI-Colour Agar for urinary tract infection detection). These products are designed for laboratory use in microbiological testing and diagnostics.

BioMaxima Spółka Akcyjna is headquartered in Poland. The company’s location is relevant for regulatory compliance, as it operates under the EU Medical Device Regulations, which govern the classification and authorization of its products within the European market.

Yes, BioMaxima’s devices are listed in the EUDAMED database, which is the European Union’s central registry for medical devices. This registry ensures transparency and traceability of devices authorized under EU Medical Device Regulations, including those classified as Class A, B, or C.

BioMaxima’s products fall under EU Medical Device Regulations (MDR) classifications of Class A, Class B, and Class C. The classification depends on factors like the intended use, risk level, and potential impact on patient health or safety. For example, general microbiological culture media like nutrient agar may qualify as Class A, while specialized diagnostic reagents (e.g., Chromogenic E. coli 0157 Agar) could be classified as higher-risk devices like Class B or C due to their role in critical diagnostic testing.