Aidapt Bathrooms Ltd
Declaration of Conformity UDI:
We,
Product Manufacturer:
Address:
declare under our sole responsibility that the device;
Device Name:
GMDN:
Basic UDI-DI:
Product\Catalogue Code
VP155B
VP155D
VP155BM
VP155DM
VP155K
VP156
VP158S
VP158M
VP158L
VP158ERS
VP158ERM
VP158ERL
VP158ELS
VP158ELM
VP158ELL
Intended Purpose:
A 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, and may be collapsible or non-collapsible.
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:
Signed by, for and on behalf of Aidapt Bathrooms Limited:
Designation:
Managing Director
Issue
Issue Date
a
June 2023
Declaration of Conformity – Single-base walking stick
EU-31112
Aidapt Bathrooms Limited
Lancots Lane
Sutton
St Helens
WA9 3EX
UK
Single Base Walking Stick
31112 Single-base walking stick
5021196SBWSY5
Description
Ergonomic walking stick (height adjustable) LH
Ergonomic walking stick (height adjustable) RH
Height adjustable palm grip ergonomic walking stick LH
Height adjustable palm grip ergonomic walking stick RH
Height adjustable walking stick, wood handle
Height adjustable, folding ergonomic walking stick RH
Aluminium walking stick (small)
Aluminium walking stick (medium)
Aluminium walking stick (large)
Ergonomic aluminium walking stick RH (small)
Ergonomic aluminium walking stick RH (Medium)
Ergonomic aluminium walking stick RH (large)
Ergonomic aluminium walking stick LH (small)
Ergonomic aluminium walking stick LH (Medium)
Ergonomic aluminium walking stick LH (large)
Lancots Lane, Sutton, St Helens, Merseyside WA9 3EX UK
Author
M Adamou
Authorised Representative
Address:
Algolweg 22
3821BH Amersfoot
Netherlands
+31-33 2779210
UDI-DI
5021196634638
5021196634645
5021196774310
5021196774303
5021196634676
5021196610502
5021196751236
5021196751243
5021196751250
5021196751274
5021196751298
5021196751311
5021196751267
5021196751281
5021196751304
June 2023
Mr Mark Benyon
Authorisation
Page 1 of 1
(EU):
Aidapt B.V
M Benyon
7
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