Biolab Zrt

Biolab Zrt specializes in microbiological culture media and agar bases intended for human diagnostic use. Their products include selective and differential agars like Brilliant Green Agar, MacConkey Agar, Brain Heart Infusion Agar, and DNase Agar, as well as specialized formulations such as Triple Sugar Iron Agar and Deoxycholate Citrate Agar. These are designed for bacterial identification, isolation, and cultivation in clinical laboratory settings.

Biolab Zrt is based in Hungary (HU). Their devices fall under the scope of the European Union’s medical device regulations, specifically classified as Class A medical devices and In Vitro Diagnostic Medical Devices (IVD) under Annex II List A. This classification applies due to their use in diagnostic testing for human samples.

Yes, Biolab Zrt’s devices are registered in the EU’s eudamed database. This platform is the official EU-wide registry for medical devices and IVDs, ensuring transparency and compliance with the European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Registration here confirms their legal placement under EU regulatory oversight.

Biolab Zrt’s products are classified as Class A medical devices under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices (IVD) Annex II List A under the IVDR. This classification is based on their intended use in microbiological testing for human diagnostic purposes, where they support bacterial identification and culture without posing significant risk to patients. Class A devices are generally considered low-risk, but they still require compliance with regulatory requirements.