Certificate
Certificate
Strengthened Business Based Competence
EN ISO 13485
Appointed as the star company of the area in 2011 (Ministry of Knowledge Economy)
Certificate of company laying research institute
Certificate of venture business
Goryeong factory received the certification of GMP for reagents, which are for the use of in-vitro diagnostic medical devices
Goryeong factory received the certification of GMP for in-vitro diagnostic devices
Acquired manufacture & sale system
Licensed to manufacture items of medical device to KFDA (33 cases)
Possess technical excellence
Certified as a foreign-invested company of advanced technology Written decision (Ministry of Strategy and Finance) Appointed as a company possessing high-technology
Appointed as a company of advanced technology (Ministry of Knowledge Economy) Possess advanced detection technology
Bridgehead for the oversea markets
Certification of CE (BGMS)
-CareU™
-CareU™ SMART
License for medical device manufacture (KFDA)
-CareU™
License for medical device manufacture (KFDA)
-CareU™ SMART
License for medical device manufacture (KFDA)
-CareU™ Test strip
License for medical device manufacture (KFDA)
-CareU™ SMART Test strip
certificate of CE (aQcare TRF)
certificate of CE (aQzen RDT-G (v1))
certificate of CE (aQzen RDT-G mini)
EN ISO 15197 : 2015
Other current status of certificate
