biounit

About us

Biounit is a friend and family member for your healthy life.

Certification Status

Standard display name	License (approval) number	approval body	Permission (approval) date
Medical device manufacturing	No. 6464	Gyeongin Food and Drug Administration	June 2019
Corporate affiliated research institute	No. 2019113988	Korea Institute for Advancement of Technology	August 2019
Medical device manufacturing report	No. 19-1742	Korea Institute of Medical Device Safety Information	December 2019
factory registration	414502019450806	Korea Industrial Complex Corporation	March 2020 (1st) January 2023 (2nd)
GMP (Front process consignment manufacturer)	KCL-AABA-8106 Medical stimulation generating device	Korea Construction Living Environment Testing Institute	April 2020
Registered as a venture business	No. 20200116724 (1st) No. 20230118020027 (2nd)	technology guarantee fund	December 2020 (1st) January 2023 (2nd)
GMP (Front process consignment manufacturer)	KCL-AAAA-10921 Medical stimulation generating device	Korea Construction Living Environment Testing Institute	Aug 2022
Technologically innovative SMEs (Inno-Biz) OK	No. 220605 – 01023	Small and Medium Venture Business Department	July 2022
GMP (manufacturing client)	KCL-AAAA-15081 Biometric phenomenon measuring device Machinery for medical treatment syringes and needles	Korea Construction Living Environment Testing Institute	Aug 2022
Management Innovation Small and Medium Business (Main-Biz) OK	No. 220601-02394	Small and Medium Venture Business Department	November 2022
Materials, parts, equipment (manager) Professional company confirmation	No. 30169	Korea Evaluation Institute of Industrial Technology	Jan 2023
ISO 13485	KM23063	KIWA	April 2023
K-GMP	No. 6464	Gyeonggi Regional Food and Drug Administration	May 2023
item permission (Medical device manufacturing certification)	Jane 23-4744	Korea Institute of Medical Device Safety Information
	Jane 23-4788
	Jane 23-4749