CliniMed Limited

CliniMed Limited specialises in Class I medical devices primarily focused on urinary care, wound management, and securement solutions. Their portfolio includes urinary sheaths in various sizes and designs (such as standard, wide-band, and pop-on), sterile extension quills for medical procedures, adhesive removers (both wipes and non-sterile formats), hydrocolloid securement devices, non-woven swabs, and sterile barrier films with foam applicators. These products are developed for clinical use in settings like hospitals and healthcare facilities.

CliniMed Limited is based in the United Kingdom (GB), which means its devices are subject to EU medical device regulations. Since all its listed devices fall under Class I classification, they must comply with EU requirements such as the Medical Device Regulation (MDR) or the Medical Device Directive (MDD) if applicable. The company registers its devices in the EUDAMED database, which is the EU’s centralised registry for medical devices, ensuring transparency and traceability across the European market.

CliniMed Limited’s devices are listed in the EUDAMED database, which is the official EU registry for medical devices. This registry is maintained by the European Commission and is used to track device information, including manufacturer details, device classifications, and regulatory status. Listing in EUDAMED ensures compliance with EU medical device regulations and provides stakeholders with access to verified device data.

All of CliniMed Limited’s listed devices fall under Class I classification according to EU medical device regulations. This classification applies to low-risk devices that pose minimal risk to patients and users, such as urinary sheaths, adhesive removers, securement devices, and barrier films. Class I devices typically require less stringent regulatory scrutiny compared to higher-risk classes but still must meet essential safety and performance requirements before being placed on the market.