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InBody 770 EC Declaration of Conformity

InBody 770 EC Declaration of Conformity

Product catalog summary
EC Declaration of Conformity Summary
Company Information:
InBody Co., Ltd.
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
Device Information:
Product: InBody770, Body Composition Analyzer
Classification: ClassⅡa (AnnexⅨ Rule 10)
Compliance:
The device complies with the essential requirements and provisions of Council Directive 93/42/EEC as amended by Directive 2007/47/EC. It conforms to the national standards transposing harmonized standards EN ISO 14971:2012, EN 60601-1:2006, EN 60601-1-2:2015.
Conformity Assessment:
The device is 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.
Authorized Representative in EU:
Name: InBody Europe B.V.
Address: Hessenbergweg 75A 1101CX, Amsterdam-Zuidoost, The Netherlands
Tel: +31-20-2386080
Signatory:
President: Ki Chul, Cha
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Catalog excerpts

InBody 770 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 InBody770, 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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