CERTIFICATION AND STATE REGISTRATION
The production of devices is certifi ed pursuant to international standards such as ISO 9001, ISO
13485, ISO 14001. The device meets international standards IEC60601-1+A1+A2, IEC60601-1-
2+A1/IEC60601-1-2 CISPR 11+A1. Device comply with the requirements of European Directive
MDD 93/42/ЕЕС.
Produced by Nihon Seimitsu Sokki Co., Ltd.
Address: 2508-13 Nakago Shibukawa Gunma 377-0293 Japan
website: http://www.nissei-kk.co.jp/english/
EC-Representative: Nissei Healthcare (UK) Ltd.
Henfi eld, BN5 9SJ UK
website: http://www.nisseihealthcare.com
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