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DEcLARATION OF cONFORMITY
Address:
SCIFIT Ltd (UK)
Lexham House, Forest Road
Binfield, Berkshire, RG42 4HP
United Kingdom
EU Support: +44 1344 300022
Email:
info@scifit.uk.com
Web:
www.scifit.uk.com
Manufacturer: SCIFIT Ltd (UK)
Product:
Step One – Stepper
Class A (high accuracy class) per EN957-1:2005
Class S (commercial use class) per EN957-1:2005
We, SCIFIT Systems, Inc., hereby declare that the product listed above is in conformity
with the following standards and/or normative documents:
ISO 9001:2008
EN 957-1:2005
EN 957-8:1998
EN 60601-1-2:2007
EN 60601-1:2006
EN 62304:2006
Steve Wright
European Business Development Director
April 2, 2013
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SCIFIT
Scientific Solutions For Fitness

cERTIFIcERINGEN

Als op het label van uw StepOne-apparaat CE staat, gevolgd door
"0434", dan betreft het een medisch apparaat. Het label bevindt zich
op de voorzijde van het apparaat, naast het serienummer.
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DECLARATION OF CONFORMITY
Address:
SCIFIT Ltd (UK)
Lexham House, Forest Road
Binfield, Berkshire, RG42 4HP
United Kingdom
EU Support: +44 1344 300022
Email:
info@scifit.uk.com
Web:
www.scifit.uk.com
Manufacture:
Product:
Step One – Recumbent Stepper Trainer
Class IIa device per rule 10 of Annex IX of 93/42/EEC.
Class A (high accuracy class) per EN957-1:2005
Class S (commercial use class) per EN957-1:2005
We, SCIFIT Systems, Inc., hereby declare that the product listed above is in
conformity with the essential requirements of the EC Council Directive 93/42
EEC Medical Device Directive, as amended by 2007/47/EC and is in conformity
with the following standards and/or normative documents:
ISO 13485:2012
ISO 9001:2008
EN 957-1:2005
EN 957-8:2009
EN 60601-1-2:2007
EN 60601-1: 2005
EN 62304:2006


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SCIFIT
Scientific Solutions For Fitness
0434
SCIFIT Ltd (UK)
Steve Wright
UK Managing Director
14 October, 2013
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