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InBody 120 EC Declaration of Conformity

InBody 120 EC Declaration of Conformity
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InBody 120 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 InBody120/120R, 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 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-super-Mare, 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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