Boditech Med Inc.

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CEO

Choi eui yeol

43, Geodudanji 1-gil, Dongnae-myeon, Chuncheon-si, Gangwon-do, Republic of Korea

Company Overview

Boditech Med Inc. has been developing products for in-vitro diagnostics and diagnostic reagents for the past 20 years. Our company value "Respect for Life" puts the emphasis on customer satisfaction. In particular, some 50,000 ichroma™ readers have been installed worldwide. Ichroma™ CRP (C-Reactive Protein) has secured its largest market share in China, showing a unique competitiveness.
Boditech Med is leading the way in exploring new markets through the automation of on-site diagnosed immunodiagnostic devices and the development of new high-sensitive diagnostic reagents. We have built up our reputation by successfully carrying out various national R&D projects, based on solid technology, experience, and human resources.

History

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Outcome

FDA 510k-CRP Clearance letter
hemochroma Plus CLIA categorization notification waived (CR160697)
hemochroma Plus 510(k)
MDSAP certification
ISO 13485
CE
Certificate of Compliance with Korean Good Manufacturing Practice (KGMP) on manufacture and quality management for medical devices