ISO13485 : 2016 / EN ISO13485 : 2016
Obtained in May 2020 (BSI)
CE Mark
Conformité Européenne: Certificate ensuring safety and quality management for the protection of European consumers and the environment
MDSAP ISO13485:2016
Certified under the Medical Device Single Audit Program for the United States, Australia, Canada, Brazil, and Japan
FDA : Food and Drug Administration
CB scheme certificate
Certification of conformity to standards for electrical equipment (IECEE)
by the International Electrotechnical Commission
UL Certificate (NRTL)
Compliance with safety standards of the Nationally Recognized Testing Laboratory (NRTL)
MEDIANA Co., Ltd.
R&D Office : 132, Donghwagongdan-ro, Munmak-eup, Wonju-si, Gangwon-do, Korea
Seoul Office : 53, Donggwang-ro, Seocho-gu, Seoul , Korea
TEL : +82-033-742-5400 FAX : +82-033-752-5483
E-mail : info@mediana.co.kr
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