Regulatory Information

CorneaGen’s labs maintain the highest levels of quality through active participation in and review by the Eye Bank Association of America (EBAA) and the U.S. Food and Drug Administration. For more information, please contact our Quality Assurance and Regulatory Affairs Department at (877) 682-8502. Below, view or download copies of our registration and accreditation. Disclaimer: certificates below are in the process of being updated as SightLife Surgical transitions to CorneaGen.

 

CorneaGen HQ Northwest (Seattle, WA)
EBAA Accreditation Certificate (Seattle, WA) valid through June 30, 2021
   
FDA Registration Certificate (Seattle, WA) valid through December 31, 2018
   
California Registration Certificate (Seattle, WA lab) valid through October 03, 2019
   
Florida Registration Certificate (Seattle, WA lab) valid through October 23, 2018
   
Health Canada Registration Certificate valid through December 31, 2019
   
Maryland Tissue Bank Permit (Seattle, WA lab) valid through June 30, 2020
   
New York State Tissue Bank License (Seattle, WA lab) valid through December 1, 2020
CorneaGen Northern California (South San Francisco, CA)
EBAA Accreditation Certificate (South San Francisco, CA lab) valid through June 30, 2021
   
FDA Registration Certificate (South San Francisco, CA lab) valid through December 31, 2018
   
California Registration Certificate (South San Francisco, CA lab) valid through October 03, 2019
   
Florida Registration Certificate (South San Francisco, CA lab) valid through January 12, 2019
   
Maryland Tissue Bank Permit (South San Francisco, CA lab) valid through June 30, 2019
   
New York State Tissue Bank License (South San Francisco, CA lab) valid through December 1, 2020
CorneaGen Southern California (Irvine, CA)
EBAA Accreditation Certificate (Irvine, CA lab) valid through June 30, 2021
   
FDA Registration Certificate (Irvine, CA lab) valid through December 31, 2018
   
California Registration Certificate (Irvine,CA lab) valid through October 03, 2019
   
Florida Registration Certificate (Irvine,CA lab) valid through January 12, 2019
   
Maryland Tissue Bank Permit (Irvine, CA lab) valid through June 30, 2019
   
New York State Tissue Bank License (Irvine, CA lab) valid through December 1, 2020
CorneaGen Northeast (Bethlehem, PA)
EBAA Accreditation Certificate (Bethlehem, PA lab) valid through November 30, 2020
   
FDA Registration Certificate (Bethlehem, PA lab) valid through December 31, 2018
   
California Registration Certificate (Bethlehem, PA lab) valid through October 03, 2019
   
Florida Registration Certificate (Bethlehem, PA lab) valid through January 12, 2019
   
Maryland Tissue Bank Permit (Bethlehem, PA lab) valid through June 30, 2019
   
New York State Tissue Bank License (Bethlehem, PA lab) valid through December 1, 2020
CorneaGen Southeast (Winston-Salem, NC)
EBAA Accreditation Certificate (Winston-Salem, NC lab) valid through June 30, 2020
   
FDA Registration Certificate (Winston-Salem, NC lab) valid through December 31, 2018
   
California Registration Certificate (Winston-Salem, NC lab) valid through October 03, 2019
   
CE Mark (Winston-Salem, NC lab) valid through April, 20, 2020
   
Florida Registration Certificate (Winston-Salem, NC lab) valid through January 23, 2019
   
Health Canada Medical Device License (Winston-Salem, NC lab)
   
ISO Cert (Winston-Salem, NC lab) valid through February 15, 2019
   
Maryland Tissue Bank Permit (Winston-Salem, NC lab) valid through June, 30, 2020
   
New York State Tissue Bank License (Winston-Salem, NC lab) valid through December 1, 2020