2. Fysic
  3. FW-400 Light Therapy Lamp

Fysic FW-400 Light Therapy Lamp User manual

  • Hello! I've reviewed the EC-Declaration of Conformity for the Daylight Therapy Lamp FW-400. This document confirms its compliance with relevant European Union directives, including medical device and substance regulations. I am ready to answer any questions you have about this document or the device it concerns.
  • What type of product does this declaration concern?
    What is the model name of the product?
    Which European Union Directives does this product comply with?
EC-Declaration of Conformity
We, the undersigned,
Company
Hesdo bv
Address, City
Aziëlaan 12, s-Hertogenbosch
Country
The Netherlands
Declare under our sole responsibility that the following equipment:
Product description / Intended use
Daylight Therapy Lamp
Name / model
Fysic FW-400
Presume conformity with the essential requirements of the European Union Directives as mentioned below. The
mentioned harmonised standards have been used to verify the presumption of conformity.
93/42/EC (MDD)
EN 60601-1 : 2005 + CORR.1 (2006) + CORR.2 (2007)
EN 60601-1-2 : 2007 /AC:2010
EN 60601-1-6 : 2010
EN 60601-1-11 : 2010
EN 60601-2-57 : 2011
EN 62366 : 2007
EN 62304 : 2006
SGS NB 0598 Annex V assessment and certification FI15/07013PO
2011/65/EC (RoHS 2)
1907/2006 (REACH)
Drawn up in
‘s-Hertogenbosch
Date
August 15, 2018
Name and position
J.H.A.M. Roording CTO
/