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

ISO 13485

2003 Certificate acquisition

(Quality management system certificate)

GMP Certificate

2003 Certificate acquisition

(Quality management system certificate)

MFDS Approval

(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)

Tissue Bank License