The accreditations and licences are as follows:

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.

San Antonio, USA

  • Federal Food and Drug Administration (FDA) Registration # 3009234552
  • American Association of Tissue Banks (AATB) Accreditation # 00212 view here
  • California Tissue Bank License # CNC 80949
  • New York Tissue Bank License # CP173TP141TS145
  • Maryland Tissue Bank License # TB1898
  • Florida Tissue Bank License # 212

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