Global Leaders in Biologics
Company Credentials
- RTI Biologics, Inc.
- (formerly Regeneration Technologies, Inc.)
- 11621 Research Circle
- Alachua, Florida 32615
- RTI Biologics, Inc.
- (formerly Tutogen Medical, Inc.)
- 13709 Progress Boulevard
- Alachua, Florida 32615
- Tutogen Medical, GmbH
- Industriestra Be 6
- Neunkirchen, Germany D-91077
American Association of Tissue Banks (AATB)
FDA Establishment Registration and Listing for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
FDA Establishment Registration for Medical Devices
International Organization of Standards (ISO)
- ISO 13485: 2003 - RTI Biologics
- ISO 13485: 2003 - Tutogen Medical, GmbH
- ISO 13485: 2003 CMDCAS - RTI Biologics
- ISO 13485: 2003 CMDAS - Tutogen Medical, GmbH
- ISO 9001: 2000 - Tutogen Medical, GmbH
International Tissue Bank Licenses
- Canada - CTO Registration Certificate - RTI Biologics
- Canada - Registration Certificate - Medical Device - RTI Biologics
State Tissue Banking Licenses
- State of California Tissue Bank License - RTI Biologics
- State of Florida Tissue Bank License - RTI Biologics
- State of Florida Tissue Bank License - formerly Tutogen Medical
- State of Maryland Tissue Bank License - RTI Biologics
- State of New York Tissue Bank License - RTI Biologics
- State of Oregon Registration Letter - RTI Biologics
- State of Illinois Registration Letter - RTI Biologics
* These are the only states that require licensure for processing and distributing human tissue.