Medicare Hygiene Limited

Medicare Hygiene Limited specializes in single-use wound care products. Their portfolio includes swabs (branded as Mediswab), wound dressings (Medica), wound cleansing devices (Medimop), and plastic medical disposables (Mediplast). These products are designed for clinical hygiene and infection control in healthcare environments.

The company is headquartered in India. While their regulatory compliance and device classifications follow EU standards, their manufacturing operations are based in India, where they likely adhere to local and international medical device regulations.

Medicare Hygiene Limited’s devices are registered in the EUDAMED database, which is the European Union’s centralised registry for medical devices. This registration is required for devices placed on the EU market, ensuring traceability and compliance with EU regulations.

The company’s devices fall into two classification categories under EU medical device regulations: Class I and Class IIa. This classification is determined by factors like the intended use, duration of use, and potential risks associated with the device, ensuring appropriate regulatory oversight.