Certificates
Tissue Establishment
Registration
Tissue Establishment Registration &
Product Listing
Human Cell, Tissue and Cellular and Tissue – Based Products.
FDA 510(k) Clearance
Tissue Establishment Registration &
Product Listing
Trade/Device name: SurFuse Gel and Putty,
Exfuse Gel and Putty
AATB accreditation
The First AATB accredited
Bone and Skin Tissue Processor
outside of North America
Tissue Bank License
Required States
Tissue Bank License
Required States
GMP Certificate
2003 Certificate acquisition
(Quality management system certificate)
MFDS Approval
MFDS
(Ministry of Food and Drug Safety)
Tissue Bank Approval
First Tissue Registered in Korea “2005”
CTO Registration Certificate
2011 Certificate acquisition
(Canada Human Tissue Certificate)
