Accreditations and licenses

Leeds, UK

• Certificate of Registration for ‘Quality Management System - ISO 13485:2016 & EN ISO 13485:2016’. Issued by notified body, BSI.
• Certificate of Accreditation, Designation, Authorisation or Licence of an Importing Tissue Establishment. Issued by Human Tissue Authority (HTA), UK.
• 510(k) approval for SurgiPure™ XD product. Authorised by the FDA, US.
• CE Certification for OrthoPure XT product.