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InBody S10 EC Declaration of Conformity

InBody S10 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: InBody S10, Body Composition Analyzer
Classification: Class IIa (Annex IX Rule 10)
Conformity Standards:
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 Procedure:
The device is subject to the procedure set out in Annex II (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.
Declaration Date:
March 5, 2019
Authorized Signatory:
Ki Chul, Cha, President of InBody Co., Ltd.
EU Authorized Representative:
Name: InBody Europe B.V.
Address: Hessenbergweg 75A 1101CX, Amsterdam-Zuidoost, The Netherlands
Tel: +31-20-2386080
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Catalog excerpts

InBody S10 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 devices described hereafter InBody S10, 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 Mar, 05, 2019 [EU Authorized Representative] Name: InBody Europe B.V. Address: Hessenbergweg 75A 1101CX, Amsterdam-Zuidoost, The Netherlands Tel: +31-20-2386080

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