Is InBody a medical device?
InBody has been accredited as a medical device since 1997, certified in USA, EU, Japan, China and more than 30 countries.
Here, you can see main certificates with explanations, and can request the file.
Body Water Analyzer
For Medical Professionals
InBody Co., Ltd. complies with the quality management system according to international standards. We satisfies country-specific regulatory requirements that apply to product safety and performance, and provides related services.
CE MDD stands for Medical Device Directive 2014/31/EU and 93/42/EEC as amended by 2007/47/EC. The Medical Devices Directive covers the regulatory requirements of the European Union for Medical Devices. Compliance with the requirements of the Medical Devices Directive is declared by placing the CE Marking on the product, and supplying the device with a Declaration of Conformity. Currently, the transition to the EU MDR, Medical Device Regulation is being made.
NAWI stands for Non-Automatic Weighing Instruments. Weighing instruments used for medical weighing have to comply with the requirements of the NAWI directive 2014/31/EU. The directive is implemented in the UK by the Non-automatic weighing Instruments Regulation 2002.
‘M’ Label indicating conformity with the Directive and the Regulations.
ISO 9001 is the international standard for creating a Quality Management Systems (QMS), published by ISO (the International Organization for Standardization).
ISO 9001 certification provides your customers reassurance that you have established a Quality Management System based on the seven quality management principles of ISO 9001.