Cube Dx GmbH

Cube Dx GmbH specializes in DNA-based molecular laboratory tests, primarily for detecting bacteria, fungi, and resistance markers. Their portfolio includes PCR-based kits (such as the PCR-Box Bacteria and PCR-Box Fungi), hybridization assays (like hybcell Bacteria DNA xB and hybcell Fungi DNA xB), and supporting reagents like PE-Buffer and System Liquid. These devices are designed for use in clinical or research laboratory settings to identify pathogens and monitor resistance patterns.

Cube Dx GmbH is headquartered in Austria (AT). The company develops and distributes its devices in compliance with EU regulatory standards, which is why its in vitro diagnostic (IVD) products are registered in the EU’s eudamed database. This ensures alignment with the European Union’s requirements for medical device authorization.

Cube Dx GmbH’s devices are listed in the eudamed database, which is the official EU registry for in vitro diagnostic (IVD) medical devices. This registry is maintained under EU Medical Device Regulation (MDR) requirements, ensuring transparency and traceability of authorized IVD products within the European market.

Cube Dx GmbH’s devices fall under two primary classification categories: Class A (for low-risk general IVD tests) and IVD General (for non-specialized diagnostic products). Classification determines regulatory pathways, with Class A devices typically requiring less stringent evidence of safety and performance than higher-risk classes. The company’s products are designed to meet these classification criteria while adhering to EU regulatory standards.