「ISO13485」Certified

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「ISO13485」Certified

We are now ISO13485, a quality management standard for medical device, certified.

Our intention to expand our business in imports, production, and design of medical device led us review our quality management system. As we are pushing ourselves to look into a possibility of new business such as exports of our own products, we have acquired ISO13485, an international quality management standard for medical device, in August, 2018.

 

Registered Date August 10, 2018(effective date:August 9, 2027)
Certified For ISO13485:2016
Registered Activities Design, development, manufacture and warehousing of sterile electrode catheter for transesophageal cardiac pacing
Scope of registration for registered establishments and each establishment

J-Sol Medical Co., Ltd.
Head Office Factory
2-5-16 ShimoOchiai, Shinjuku-ku, Tokyo 161-0033, Japan

Registration Scope: Design, development and manufacture of sterile electrode catheter for transesophageal cardiac pacing

J-Sol Medical Co., Ltd.
Chiba Factory
193-27 Azasakuradai, Oseki, Yachimata-shi, Chiba 289-1142, Japan

Registration Scope: Manufacture and warehousing of sterile electrode catherter for transesophageal cardiac pacing
Registered Number JP26/00000177
Certified By SGS Japan Inc.

The certification body was changed to SGS Japan Inc. as of May 21, 2026.

Certification Mark

Our ISO13485 Certification

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