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Regulatory Licensing Documentation

 LifeCell's patented human tissue matrix, Alloderm®, has been successfully used in over 1 million grafts and implants to date, and a growing body of clinical evidence points to its potential use in a host of other surgical applications.
In order to improve efficiencies for our customers, distribution partners and tissue bank partners, LifeCell provides this REGULATORY/LICENSING DOCUMENTATION page to allow interested parties with regulatory responsibilities and/or the general community to access and review frequently requested documents pertaining to LifeCell certification, registrations and licensing.

  1. AATB Certificate
  2. FDA Establishment Registration and Listing for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
  3. California Provisional Tissue Bank License
  4. Florida Tissue Bank Certificate
  5. New York License for Tissue Bank Operation
  6. Maryland Tissue Bank Permit
  7. Illinois Renewal for Tissue Bank
  8. ISO Certificate 9001:2000
  9. ISO certificate 13485:2003
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