History

2024

April(Export) Approval for Graft/Prosthesis material - UREVS VollaFill

July Clinical Trials for REVS TF Collagen (4 Cosmetic Products) - Completed clinical testing for anti-aging effects on human skin - Completed human skin irritation test (primary) - Completed alternative eye irritation test (HET-CAM)

AugustKFDA Product Approval (Domestic) for Wound Dressing, fluid-impermeable film - UREVS O / R / D

SeptemberKFDA Product Approval for Wound Dressing, Topical hydrogel - UREVS Pro Hydro Bead

OctoberKFDA Product Approval for Wound Dressing, fluid-impermeable film - UREVS PRO HYDRO

2023

JanuaryGraft/Prosthesis, KFDA Product Approval Replengen Light -

AprilExport Approval for Graft/Prosthesis material UREVS Loheve - UREVS Loheve Plus -

2022

DecemberExport Approval for Graft/Prosthesis material - UREVS PRO 32RX

November - CPNP Registration for 7 Cosmetic Products (EU Cosmetic Product Notification Portal)

2021

November Registration in the United States RMT140HPn KFDA Approval for Graft/Prosthesis materia - Replengen Mid / Mid V / Mid Light / Mid Light V -

June Approval for Exploratory Clinical Trial HDC-3D (Extended-Release Painless Drug Delivery Device) -

2020

May KFDA Product Approval for Graft/Prosthesis material (first) - Replengen Pro

2019

October ISO 22716: Certification for Cosmetic GMP (Good Manufacturing Practice) -

April ISO 9001: Certification for Quality Management System -

March Replengen HA Filler: Clinical Trial Initiated -

2018

April- ISO 13485: Certification for Medical Devices Quality Management System

January GMP Certification for Medical Devices - For Human Tissue or Function Replacement Products

2017

July GMP Certification for In Vitro Medical Devices Surgical supplies -

2016

October- Medical Device Manufacturing Business License (No. 5494)

May- Cosmetic Manufacturer Registration (No. 2324)

March- Cosmetics manufacturing and sales business registration (No. 7500) - Venture business verification certification (No. 20160102567)