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InBody 370S EC Declaration of Conformity

InBody 370S EC Declaration of Conformity
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InBody 370S EC Declaration of Conformity - 1

InBody Co., Ltd. Address: [Head Office] InBody Bldg., 625, Eonju-ro, Gangnam-gu, Seoul 06106 KOREA [Factory] 15, Heugam-gil, Ipjang-myeon, Seobuk-gu, Cheonan-si, Chungcheongnam-do, 31025 KOREA Tel: +82-2-501-3939 Fax: +82-2-578-2716 declares that the medical device described hereafter InBody370S, Body Composition Analyzer, has been classified as ClassⅡa (AnnexⅨ Rule 10) and are in conformity with the essential requirements and provisions of Council Directive 93/42/EEC as amended by Directive 2007/47/EC and are in conformity with the national standards transposing harmonized standards EN ISO 14971:2012, EN 60601-1:2006, EN 60601-1-2:2015 and are subject to the procedure set out in AnnexⅡ(excluding section 4) of Directive 93/42/EEC as amended by Directive 2007/47/EC under the supervision of Notified Body Number 0120, SGS United Kingdom Ltd, 202B Worle Parkway, Weston-superMare, BS22 6WA, United Kingdom [EU Authorized Representative] Name: InBody Europe B.V. Address: Hessenbergweg 75A 1101CX, Amsterdam-Zuidoost, The Netherlands Tel: +31-20-2386080

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