Company Credentials

Company Credentials

The following facilities are licensed for manufacturing, processing, storing and distribution. For a full list of our locations, please visit our contact us page.

11621 Research Circle
Alachua, Florida 32615

13709 Progress Boulevard
Alachua, Florida 32615

Industriestrasse 6
Neunkirchen am Brand,
Germany D-91077

North Carolina
1800 A. North Greene Street
Greenville, North Carolina 27834

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 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.

FDA Establishment Registration for Medical Devices

International Organization of Standards (ISO)

International Facility Registrations

Medical Device Single Audit Program (MDSAP)

State Tissue Banking Licenses

* These are the only states that require licensure for processing and distributing human tissue.

Biomedical Laboratory Certifications and Permits

CE Certificates

  • CE 52820 - FKA Pioneer Surgical Technology (Greenville)