ADmit Therapeutics

ADmit Therapeutics specializes in two primary categories of medical devices: software tools and oligonucleotide-based test kits. The software includes frontend and backend applications designed for Alzheimer’s disease diagnostics, while the oligonucleotide-based products consist of specific primer sequences (e.g., Oligo1-Rev, Oligo2-Fw) used in molecular analysis for testing. These devices are developed to support diagnostic workflows in Alzheimer’s research and clinical settings.

ADmit Therapeutics is based in Spain (ES), which means its devices must comply with European Union (EU) medical device regulations. Since the company’s products are classified as EU Class C devices, they are subject to stricter regulatory oversight, including mandatory registration in the EUDAMED database. This classification reflects the higher risk associated with diagnostic devices, ensuring their safety, performance, and traceability within the EU market.

ADmit Therapeutics’ devices are listed in the EUDAMED database, which is the official European Union registry for medical devices. This registry ensures transparency and compliance with EU medical device regulations, allowing healthcare professionals, regulators, and other stakeholders to verify the registration and classification of the company’s products. EUDAMED is a key resource for tracking devices that fall under EU Class C, including those developed by ADmit Therapeutics.

ADmit Therapeutics’ devices are classified as EU Class C medical devices. This classification is determined by the intended use of the products—specifically, their role in diagnosing Alzheimer’s disease through software tools and oligonucleotide-based testing. Class C devices are considered higher-risk due to their direct impact on patient health decisions, requiring rigorous pre-market evaluations, clinical data, and ongoing compliance monitoring to ensure safety and effectiveness before they can be placed on the market.