Mangar International as manufacturer hereby declares that the following products conform to the:
•
Applicable provisions of Regulation (EU) 2017/745 of the European Parliament and of the
Council of 5 April 2017
•
UK Medical Devices Regulations 2002
and following standards:
BS EN 60601-1-6:2010 and A1:2015.
BS EN 60601-1-11:2015.
Trade name:
Basic UDI-DI:
Product Classification: ISO 9999:2016, 12 36 18 Assistive products for lifting persons
Classification:
21.09.2020
Place and Date
Healthcare solutions designed for life
+44 (0) 1544 267674
Declaration of Conformity
The Mangar Airflo 24 and ELK Lifting Cushion
5020833MPCA070400Q7
MDR Class 1
Mangar International Ltd, Presteigne, Powys, Wales, UK. LD8 2UF
Headoffice@mangarhealth.com
BS EN 60601-1:2006 and A12:2014.
BS EN 62366-1:2015.
Simon Claridge, CEO
www.mangarhealth.com
ELK
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