ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ

Archem Sağlık manufactures in-vitro diagnostic (IVD) test kits and reagents, including clinical chemistry assays like D-dimer, LDL cholesterol, albumin, and liver function markers such as GPT (ALT). Their portfolio also covers calcium measurement reagents and detergent solutions specifically designed for cleaning ultrasound probes, such as Probe Cleanser and CD80 Detergent. These products are developed for laboratory use to aid in diagnostic testing and equipment maintenance.

Archem Sağlık is based in Turkey. The company specializes in producing IVD reagents and test kits, aligning its operations with regulatory standards relevant to its market presence, including the European market where its devices are registered.

Archem Sağlık’s devices are listed in the eudamed database, which is the European Union’s central registry for medical devices. This registry ensures transparency and compliance with EU regulatory requirements for in-vitro diagnostics, including Class A and IVD General classifications.

Archem Sağlık’s devices fall under Class A (low-risk IVD reagents and test kits) and IVD General classifications. These classifications are determined based on factors like the intended use, potential risks, and the level of intervention required for patient diagnosis or monitoring. Class A devices are typically considered low-risk, while IVD General includes diagnostic tests that require regulatory oversight but do not pose significant health risks.