Company Credentials

American Association of Tissue Banks (AATB)

• AATB Accreditation Certificate - (Florida)

FDA Establishment Registration and Listing for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

FDA establishment registrations for 361 HCT/Ps and medical devices are submitted annually and valid for the annual registration year (HCT/P) or until expiration date (devices) as listed.

• RTI Surgical, Inc. - (Florida)
• Tutogen Medical, GmbH - (Germany)

FDA Establishment Registration for Medical Devices

• RTI Surgical, Inc. - (Florida)
• Tutogen Medical, GmbH - (Germany)
• Cook Biotech - (Indiana)

FDA Drug Establishment Registration

• Cook Biotech – (Indiana)

International Organization of Standards (ISO)

• ISO 13485: 2016 - Tutogen Medical, GmbH (Germany)
• ISO 13485: 2016 - RTI Surgical (Florida)‍
• ISO 13485: 2016 & EN ISO 13485: 2016 -  Collagen Solutions (United Kingdom)‍
• ISO 13485: 2016 & EN ISO 13485: 2016 - Collagen Solutions (New Zealand)
• ISO 13485: 2016 – Collagen Solutions/Tissx (Minnesota)
• ISO 13485: 2016 – Collagen Solutions (Minnesota)
• ISO 13485: 2016 & EN ISO 13485: 2016 – Cook Biotech (Indiana)

European Directorate for the Quality of Medicines & Healthcare (EDQM)

• CEP 2018-135 – Collagen Solutions (Minnesota)

Animal and Plant Health Inspection Service (APHIS)

• EC 1069/2009 & EU 142/2011 – Collagen Solutions (Minnesota)

International Facility Registrations

• Canada - CTO Registration Certificate - Tissue - RTI Surgical (Florida)
• Canada - Registration Certificate - Medical Device - RTI Surgical (Florida)
  

Medical Device Single Audit Program (MDSAP)

• MDSAP 704608 - RTI Surgical (Florida)
• MDSAP – 743355 - Cook Biotech (Indiana)

State Tissue Banking Licenses

• State of California Tissue Bank License - RTI Surgical (Florida)
  
• State of Florida Tissue Bank License - RTI Surgical (Florida)
  
• State of Florida Tissue Bank License - RTI Surgical (Florida, South Wing)
  
• State of Maryland Tissue Bank License - RTI Surgical (Florida)
  
• State of New York Tissue Bank License - RTI Surgical (Florida)
  
• State of Oregon Registration Letter - RTI Surgical (Florida)
  
• State of Illinois Registration Letter - RTI Surgical (Florida)
• State of Delaware Tissue Bank Registration - RTI Surgical (Florida)