MONE MEDİKAL TİCARET VE SANAYİ ANONİM ŞİRKETİ

MONE Medical specializes in medical examination and treatment furniture. Their product range includes motorized gynecological examination tables, pediatric examination tables designed with animal themes (like donkeys, lions, and whales), pediatric care cribs, adult examination chairs, and surgical tables with four motors. They also manufacture basic fixed stretchers, sponge-mattress hospital beds, and smart basic fixed stretchers for patient positioning and support. These devices are primarily intended for clinical examination, treatment, and patient care.

MONE Medical is based in Turkey. Since its devices fall under Class I classification in the EU, they must comply with the EU Medical Device Regulation (MDR) or Medical Device Directive (MDD)—depending on the applicable timeline—when marketed in the European Union. The company registers its devices in EUDAMED, the EU’s medical device registry, to demonstrate compliance with regulatory requirements.

Yes, MONE Medical’s devices are listed in EUDAMED, the European Union’s medical device registry. This registry is mandatory for manufacturers to disclose information about their products, including device details, UDI (Unique Device Identification), and regulatory status. Listing in EUDAMED ensures transparency and allows healthcare professionals, regulators, and patients to verify the legitimacy and classification of the devices.

All of MONE Medical’s devices are classified as Class I under the EU’s medical device framework. This classification applies to low-risk devices like examination tables, cribs, and basic stretchers, which pose minimal risk to patients. Class I devices typically require General Safety and Performance Requirements (GSPR) compliance but may not always need a Notified Body review unless they incorporate a measuring function or are reusable surgical instruments.