Award/certifcation

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CE0120 (MDD 93/42/EEC)
Medical Devices
Directive 93/42/EE
ISO 13485:2003
Quality Management Systems-Medical devices-Requirements for regulatory purposes
ISO 9001:2008
Quality /management Systems-Design, development and manufacture of low-temperature plasma sterilizer in RENOSEM series
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GMP
(Good Manufacturing
Practice)
TGA (Therapeutic
Goods Administration)

Certified from Department of Health and Ageing Australian Government
Certificate of Venture Company
Certified as Venture Company by Korea Technology Finance Corporation
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Recommendation of Purchasing of Excellent Product
Acquired recommendation from Korea Invention Promotion Association
Certificate of Utility Model Registration
Registered by the Korean Intellectual Property
Certificate of Patent
Registered by the Korean Intellectual Property Office
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KFDA (Korea Food
& Drug Administration)

Certified by KFDA
Industrial R&D Center
Selected as Industrial R&D Center by Korea Industrial Technology Association
Certificate of INNOBIZ
Certified from SBA
chasedae award14
Next generation World-class product
2012.12 Selected by Ministry of Knowledge Economy
Promising Export Small business
2012.06 Selected by the Small and Medium Business Administration
JPAL(Japan Pharmaceutical Affairs Law)
2012.12 Certificated by Japan Pharmaceutical Affairs Law
cdfa
CFDA Certificate
2016.1 certificated China Food and Drug Administration (RENO-S130D)
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