Athenese-Dx Private Limited

Athenese-Dx Private Limited specializes in in vitro diagnostic (IVD) devices, including biochemistry analyzers like the ALTA Biochemistry Analyzer. Their portfolio also includes IVD clinical equipment such as rapid test kits, ELISA kits, biochemistry reagents, and real-time PCR kits. These products are designed for use in clinical laboratories to support biochemical and molecular testing.

Athenese-Dx Private Limited is headquartered in India. The company’s location influences its regulatory compliance requirements, particularly for devices intended for markets like the European Union.

Athenese-Dx Private Limited’s devices are listed in the eudamed registry, which is the official EU database for medical devices. Listing in eudamed is required for devices placed on the European market, ensuring transparency and traceability under EU regulations.

Athenese-Dx Private Limited’s devices fall under Class A regulatory classification. This classification is typically assigned to low-risk devices, such as some in vitro diagnostics, where the risk to patients is minimal. Classification determines the regulatory pathway, documentation requirements, and post-market surveillance obligations.