OCTAMED SAĞLIK ÜRÜNLERİ SANAYİ VE TİCARET ANONİM ŞİRKETİ

OCTAMED produces single-use medical devices primarily focused on protective and wound care applications. Their portfolio includes nitrile powder-free examination gloves (available in standard and colored variants like blue), surgical tapes, and colored first aid plasters. These products are designed for clinical examinations, minor first aid, and surgical support, ensuring hygiene and usability in medical settings.

The company is based in Turkey, as indicated by its country designation. This geographical location is relevant for regulatory compliance and market distribution, particularly for devices intended for use within the EU or other regions with specific requirements.

Yes, OCTAMED’s devices are registered in the eudamed database, which is the official EU portal for medical device information. Listing in eudamed is required for Class I devices marketed within the European Economic Area (EEA) to ensure transparency and traceability under EU medical device regulations.

All of OCTAMED’s listed devices fall under EU Class I classification. This classification applies to low-risk devices like gloves, tapes, and plasters, which pose minimal risk to patients and users. Class I devices typically require conformity assessment procedures such as self-certification or a Declaration of Conformity (DoC) by the manufacturer, though specific requirements depend on the device’s intended purpose and design.