Regulation 2016-11-27T13:38:02+00:00

Regulation

All products MediTouch manufactured are FDA 510K Exempt and CE Class 1 certified.

metidouch CE
metidouch FDA

MediTouch is certified ISO9001:2008 and ISO13485:2003.

metidouch ISO9001:2008
metidouch FDA
metidouch Certified MANAGEMENT SYSTEM

Document packs

TypeRegulationPacksDate ModifiedSize

zip
MediTouch Regulation Files 20161227 27/12/2016 1:28 pm11.9M
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Document files

TypeRegulationDate ModifiedSize

pdf
ANSI-ACLASS certificate until 2014 (SII) 27/11/2016 12:40 pm54.6k

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CFDA Certificate 2016 27/11/2016 12:40 pm589.3k

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Certificate of acceptance 1 (SII) 27/11/2016 12:40 pm739.7k

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Certificate of acceptance 2 (SII) 27/11/2016 12:40 pm739.8k

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Certificate of membership (SII) 27/11/2016 12:40 pm885.7k

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EC Declaration of Conformity - 20140306 27/11/2016 12:40 pm305.6k

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EC Declaration of Conformity - 20161626 27/11/2016 12:39 pm93.8k

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EULA MediTutor 161121 21/11/2016 8:29 am118.4k

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FDA 2016 Registration 27/11/2016 12:40 pm127.7k

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Free Sale Certificate 31Oct2016 27/11/2016 12:40 pm1.2M

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HandTutor수입품목신고증 27/11/2016 12:41 pm1.8M

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IEC 60601-1 Certificate 27/11/2016 12:40 pm141.1k

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IEC 60601-1 Certificate C136140.01 27/11/2016 12:40 pm100.2k

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IEC 60601-1 Test Report 27/11/2016 12:40 pm932.2k

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IEC 60601-1 Test Report S136140.01 27/11/2016 12:41 pm3.7M

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IEC 60601-1-2 Certificate K136150.01 27/11/2016 12:41 pm268.7k

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IEC 60601-1-2 Test Report E136150.01 27/11/2016 12:41 pm1M

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MEDITOUCH CE 27/11/2016 12:39 pm100.6k

pdf
MediTouch ISO 9001-2008 2019Sep7 27/11/2016 12:41 pm2.6M

pdf
MediTouch ISO 13485-2003 2019Feb25 27/11/2016 12:41 pm2.4M

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handtutor수입품목신고증 27/11/2016 12:41 pm1.1M

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handtutor수입품목신고증2 27/11/2016 12:41 pm736.3k
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