‘The Korean regenerative biopharmaceutical firm CGBIO has acquired CE markings for three medical devices’, said CGBIO officials on May 21, 2020.A CE mark of compliance is an integrated proof that the product meets the quality, indications and effects, durability and safety requirements set by the the European Union (EU). The CE mark must be acquired by manufacturers with intension to advance into the European Economic Area (EEA). The mark iindicates that a product fulfills requirements of relevant European directives. Thus, acquisition of CE mark means that the quality and safety of the product are recognized to be at the international level.
ExcelOS Inject (CE certified date: February 10, 2020) is a synthetic bone graft substitute containing pure beta-tricalcium phosphate beads mixed with biodegradable hydrogel. Implanted ExcelOS Inject could be resorbed and replaced with bone during new bone information. ExcelOS
Inject is a substitute for both autogenous and allogeneic cancellous bone grafts to provide a matrix for the repair process of bone in orthopedics and dentistry.
Injectable soft tissue Implant-based Facetem S (CE MDD certified date: February 13, 2020) is a dermal filler comprised of calcium hydroxyapatite (CaHA) microspheres. The filler is used to expand dermal and subcutaneous soft tissues and correct some lesions such as acne wounds in the face.
CG GEL (CE certified date: April 2, 2020) is a hemostatic composed of polymer such as hydroxyethyl cellulose. It is indicated for healing gastrointestinal wounds associated with peptic ulcer. When the pouch-type CG GEL is applied to the affected area, its immediate gelation forms a barrier in the lesion and prevents contamination from the external environments, coupled with a wound-healing function and a hemostatic effect.
“Due to differentiation from other comparators, our products have been attracting attention from foreign partners. The three CE-certified medical devices will reach the global market including European markets,” said CGBIO officials.
Following these three new CE markings, CGBIO owns a total of 8 CE markings in addition to CuraVac, Easy Derm, NOVOMAX, LumFix, and Ali Stent.
