About us
Approval & Certification

ISO 9001:
International Standard Organization ISO 9001 Certified Quality System

(We canceled it on Oct. 2017)

Quality systems:
Medical devices Quality system. ISO13485:2016
Quality systems:
Medical devices for Canada, USA and Australia
Taiwan Ministry of Health and Welfare,  Good Manufacture Practice

CE MARK: European Committee MARK
EMC: Electro Magnetic Compatibility (radio frequency interference)
MDD: Medical device directives

PS. MDD CE expired on Oct. 2022.

USA/FDA Medical Device Premarket Notification

The safety certificate of medical device for Canada and USA.

(We canceled it from initial of 2018.)

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