InBody 570 EC Declaration of Conformity

Product catalog summary

EC Declaration of Conformity Summary

Company Information:
InBody Co., Ltd. is the manufacturer of the medical device. The head office is located in Seoul, Korea, and the factory is in Cheonan-si, Korea. Contact details include a telephone number (+82-2-501-3939) and a fax number (+82-2-578-2716).

Device Description:
The device in question is the InBody570, a Body Composition Analyzer. It is classified as a Class IIa medical device according to Annex IX Rule 10.

Compliance and Standards:
The device complies with the essential requirements of Council Directive 93/42/EEC, as amended by Directive 2007/47/EC. It also conforms to national standards transposing harmonized standards EN ISO 14971:2012, EN 60601-1:2006, and EN 60601-1-2:2015.

Conformity Assessment:
The conformity assessment procedure follows Annex II of Directive 93/42/EEC, as amended by Directive 2007/47/EC. The process is supervised by Notified Body Number 0120, SGS United Kingdom Ltd.

Declaration Date:
The declaration was made on February 9, 2019.

Authorized Signatory:
The declaration is signed by Ki Chul, Cha, President of InBody Co., Ltd.

EU Authorized Representative:
InBody Europe B.V. serves as the EU Authorized Representative, located in Amsterdam-Zuidoost, The Netherlands. Contact number is +31-20-2386080.

Catalog excerpts

InBody 570 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 InBody570, 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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