Verklaring Van Overeenstemming - Aria BKRTR Manuel D'utilisation

8. VERKLARING VAN OVEREENSTEMMING

DICHIARAZIONE DI CONFORMITÀ
Declaration of conformity
(Manufacturer)
(Medical Device) Aria® Postural Backrest Aluminium
(REF. code)
(Applicable Directives)
(CE Directive 93/42/EC concerning medical devices and fallowing updates)
Classification (Annex IX, MDD 93/42):
(Conformity Assessment procedure):
(Under our sole responsibility, we state that the above mentioned products meet all the applicable essential
requirements of Annex I of the Medical Devices Directive 93/42/EEC and all the applicable standards).
(Applicable harmonized European standards)
(The Manufacturer undertakes too keep available for the Competent Authorities the technical documentation
quoted in Annex VII of Directive 93/42/EEC for a period of at least TEN years after the last manufacture of
the product.)
(Authorized/Responsible Person)
Signed
DICHIARAZIONE DI CONFORMITÀ
Declaration of conformity
(Manufacturer)
(Medical Device) Aria® Semi Rigid Postural Backrest in Carbon Fibre
(REF. code)
(Applicable Directives)
(CE Directive 93/42/EC concerning medical devices and fallowing updates)
Classification (Annex IX, MDD 93/42):
(Conformity Assessment procedure):
(Under our sole responsibility, we state that the above mentioned products meet all the applicable essential
requirements of Annex I of the Medical Devices Directive 93/42/EEC and all the applicable standards).
(Applicable harmonized European standards)
(The Manufacturer undertakes too keep available for the Competent Authorities the technical documentation
quoted in Annex VII of Directive 93/42/EEC for a period of at least TEN years after the last manufacture of
the product.)
(Authorized/Responsible Person)
Signed
NL 54
Class I (Rule 1)
Annex VII
(The list of the applicable standards is reported in
Chapter 11 of Technical File FT1 BKRTA).
Date
Class I (Rule 1)
Annex VII
(The list of the applicable standards is reported in
Chapter 11 of Technical File FT1 BKRTS).
Date
DICHIARAZIONE DI CONFORMITÀ
Declaration of conformity
(Manufacturer)
(Medical Device) Aria® Rigid Postural Backrest in Carbon Fibre
(REF. code)
(Applicable Directives)
(CE Directive 93/42/EC concerning medical devices and fallowing updates)
Class I (Rule 1)
Classification (Annex IX, MDD 93/42):
(Conformity Assessment procedure): Annex VII
(Under our sole responsibility, we state that the above mentioned products meet all the applicable essential
requirements of Annex I of the Medical Devices Directive 93/42/EEC and all the applicable standards).
(Applicable harmonized European standards) (The list of the applicable standards is reported in
Chapter 11 of Technical File FT1 BKRTR).
(The Manufacturer undertakes too keep available for the Competent Authorities the technical documentation
quoted in Annex VII of Directive 93/42/EEC for a period of at least TEN years after the last manufacture of
the product.)
(Authorized/Responsible Person)
Signed
Date