7
Aidapt Bathrooms Ltd
Issue
a
Issue Date
June 2023
Declaration of Conformity EU– Single-base walking stick
Page
1 of 1
Declaration of Conformity UDI: EU-2203/31112
We,
Product Manufacturer: Aidapt Bathrooms Limited Authorised Representative (EU): Aidapt B.V
SRN: 2203
Address: Lancots Lane Address: Algolweg 22
Sutton 3821BH Amersfoot
St Helens Netherlands
WA9 3EX +31-33 2779210
UK
declare under our sole responsibility that the device;
Device Name: Single Base Walking Stick
GMDN: 31112 Single-base walking stick
Basic UDI-DI: 5021196SBWSY5
Height adjustable, folding ergonomic walking stick LH
Height adjustable, folding walking stick (red)
Height adjustable, folding walking stick (brown)
Height adjustable, folding walking stick (blue)
Height adjustable, folding walking stick (black)
Height adjustable, folding walking stick (wooden handle)
Height adjustable, folding walking stick (floral blue)
Height adjustable, folding walking stick (floral black)
Height adjustable, folding ergonomic walking stick RH
Intended Purpose:
A foldable walking aid made of wood or metal with one leg and a handgrip or curved handle, used to support a person with disability
to maintain their balance and support their weight while walking. Includes fixed or adjustable length models.
Object:
to which this declaration relates is classified as risk Class 1, according to the rules set out in Annex VIII,
is in conformity with the following relevant EU harmonisation legislation;
• Regulation (EU) 2017/745 relating to medical devices
and carry the required CE mark.
We confirm that the listed devices are in conformity with the following standards;
• BS EN ISO 1985:1999 Walking aids. General requirements and test methods
• BS EN ISO 14971:2019 Medical devices. Application of risk management to medical devices
Place and date of issue: Lancots Lane, Sutton, St Helens, Merseyside WA9 3EX UK June 2023
Signed by, for and on behalf of Aidapt Bathrooms Limited:
Mr Mark Benyon
Designation: Managing Director
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