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History

2019
10. Completed registration of Insulin Pen Needle and Safety Pen Needle in Canada(Health Canada)
09. Obtained certificate of Medical Device Single Audit Program(MDSAP)
08. Completed design registrations: Medical needle supporter and 2 others for Safety Pen Needle
2018
07. Changed Notified Body (SGS -> TÜV Rheinland)
02. Completed TGA registration in Australia for insulin Pen Needle
2017
04. Obtained CEMDD certificate for Safety Pen Needle, Obtained medical manufacturer certificate for Safety Pen Needle
01. Selected as first-class product for next generation for Safety Pen Needle
2016
12. Obtained ANVISA certificate
2015
12. Awarded ‘5million Dollar Export Tower’
11. Selected as a participating company for ‘P300 project’
08. Obtained CFDA certificate
07. Obtained INVIMA certificate
2012
11. Changed major shareholder
2010
08. Expanded Pen Needle production Line
2008
07. Certified GMP (Good Manufacturing Practice)
2006
06. Certified CE and ISO13485
2005
08. Approved FDA 510K
2004
05. Obtained manufacturing permission of insulin Pen Needle
2000
12. Obtained medical device manufacturing permission by KFDA
01. Established MEDEXEL CO., LTD.
2008
07. GMP
02. Export Insulin pen needle, insulin injection to USA, ASIA , Europe, Africa
02. M&A with Daejin tech
2006
06. Certificate of ISO, ISO13485, CE
2005
08. FDA 510K
2004
05. Permission of manufacturing insulin injection, insulin pump
2000
12.Permission of manufacturing by KFDA
01. Foundation of MedExel

TEL : 82-31-299-1077 / E-mail : sales@medexel.co.kr / 252, GEUMGWANGOSAN-RO, GEUMKWANG-MYEON ANSEONG-SI, GYEONGGI-DO, REPUBLIC OF KOREA

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