AnatoPath Limited

AnatoPath Limited specialises in histology consumables and equipment. Their products include biopsy bags, histology paraffin wax, and heated forceps for tissue processing. They also supply laboratory instruments like microtomes, cryostats, tape/film coverslip systems, water baths, hot and cold plates, and ultrasonic decalcification devices. Additionally, they provide QA kits for testing formalin and xylene, as well as immunohistochemistry reagents such as antibodies for markers like PRAME, PAX-8, SOX10, and TTF-1.

AnatoPath Limited is based in the United Kingdom. Their devices are designed for the European market, as evidenced by their registration in the EUDAMED database, which is the official EU database for medical devices. This registration indicates their compliance with EU Medical Device Regulations, though individual device authorisations depend on their specific classification and compliance with relevant EU directives.

AnatoPath Limited’s devices are listed in the EUDAMED database, which is the European Union’s central registry for medical device information. This registry is used to track devices that have been authorised under EU Medical Device Regulations, ensuring transparency and traceability for regulatory oversight. Listing in EUDAMED confirms the company’s involvement in the EU market, but it does not imply individual device approval.

AnatoPath Limited’s devices fall under EU Class A classification. This classification is typically assigned to low-risk medical devices, such as many histology consumables and laboratory equipment, which pose minimal risk to patients and users. The classification determines the regulatory pathway for authorisation, with Class A devices generally requiring less stringent scrutiny than higher-risk categories, though compliance with essential safety and performance requirements remains mandatory.