Certificate JP05/040035
The management system ofDaiichi Medical Co., Ltd.
Head Office 2-27-16 Hongo, Bunkyo-ku, Tokyo, 113-0033 Japan

has been assessed and certified as meeting the requirements ofISO 13485:2016
EN ISO 13485:2016
For the following activities
1. Design, manufacture, installation and service of ENT units, nebulizers and endoscope washer disinfectors
2. Design, manufacture and service of ENT chairs, iontophoretic anaesthesia machines, general high frequency surgical equipment
for ENT use, non-sterile reusable ENT surgical instruments, ENT optical equipment, orthopaedic surgical instruments and dizzinessmonitoring, treatment and examination equipment
3. Design of software for electronystagmographs and eye movement testing equipment

This certificate is valid from 08 February 2023 until 08 February 2026 and remains valid subject to satisfactory surveillance audits.
Issue 11. Certified since 08 February 2005
Certified activities performed by additional sites are listed on subsequent pages.

Authorised byJonathan Hall
Global Head - Certification Services
SGS United Kingdom Ltd
Rossmore Business Park, Ellesmere Port, Cheshire, CH65 3EN, UK
t +44 (0)151 350-6666 - www.sgs.com

This document is an authentic electronic certificate for Client’ business purposes use only. Printed version of the electronic certificate are permitted and will be considered as a copy.
This document is issued by the Company subject to SGS General Conditions of certification services available on Terms and Conditions | SGS. Attention is drawn to the limitation ofliability, indemnification and jurisdictional clauses contained therein. This document is copyright protected and any unauthorized alteration, forgery or falsification of the content orappearance of this document is unlawful.

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Certificate JP05/040035, continued

Daiichi Medical Co., Ltd.
ISO 13485:2016
EN ISO 13485:2016
Issue 11Sites
Daiichi Medical Co., Ltd.
Head Office
2-27-16 Hongo, Bunkyo-ku, Tokyo, 113-0033 Japan

1. Design, manufacture, installation and service of ENT units, nebulizers and endoscope washer disinfectors
2. Design, manufacture and service of ENT chairs, iontophoretic anaesthesia machines, general high frequency surgicalequipment for ENT use, non-sterile reusable ENT surgical instruments, ENT optical equipment, orthopaedic surgical instrumentsand dizziness monitoring, treatment and examination equipment
3. Design of software for electronystagmographs and eye movement testing equipment
Daiichi Medical Co., Ltd.
Technical Center
2-39-11 Hongo, Bunkyo-ku, Tokyo, 113-0033 Japan

Design, manufacture and service of ENT units, nebulizers and endoscope washer disinfectors, ENT chairs, iontophoretic
anaesthesia machines, general high frequency surgical equipment for ENT use, non-sterile reusable ENT surgical instruments,
ENT optical equipment and dizziness monitoring, treatment and examination equipment

This document is an authentic electronic certificate for Client’ business purposes use only. Printed version of the electronic certificate are permitted and will be considered as a copy.
This document is issued by the Company subject to SGS General Conditions of certification services available on Terms and Conditions | SGS. Attention is drawn to the limitation ofliability, indemnification and jurisdictional clauses contained therein. This document is copyright protected and any unauthorized alteration, forgery or falsification of the content orappearance of this document is unlawful.

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