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EC Declaration of Conformity

Manufacturer: Neurovalens, 4th Floor, The Warehouse, 7 James Street South, Belfast, BT2 8DN

Product: Modius™ Model ML600

Applied Council Directives:

  • General Product Safety Directive - 2001/95/EC
  • Restriction of Hazardous Substances Directive - 2011/65/EU
  • Waste Electrical and Electronic Equipment Directive 2012/19/EU
  • The Radio Equipment Directive (2014/53/EU)

Standards to which Conformity is Declared:

  • Quality Management:
    - ISO 9001:2015
  • Safety:
    - IEC/EN 60950-1: 2013
    - IEC/EN 60601-1-2:2014
    - IEC/EN 60601-1: 2005
    - IEC/EN 60601-1-11: 2015
  • EMC:
    - EN 301 489-1 V2.1.1
    - EN 301 489-17 V3.2.0

We, Neurovalens Ltd., declare under our sole responsibility that the product to which this declaration relates is in conformity with the listed directives, standards, in addition to all applicable Essential Principles for Safety and Performance.

The Technical File is maintained at and at Neurovalens, Floor 4 The Warehouse, Belfast, BT2 8DN and Compliance Solutions (Life Sciences) Ltd, 116 Almond Road, Cumbernauld, Glasgow G67 3LW, United Kingdom.

Date of Issue: 21st May 2018
Place of Issue: Northern Ireland, United Kingdom
Version Number: 3

Jason McKeown
CEO
Neurovalens Ltd