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

ISO 13485

2003 Certificate acquisition
(Quality management system certificate)

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)

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