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1. E U D e c l a r a t i o n o f C o n f o r m i t y a c c o r d i n g t o t h e M e d i c a l D e v i c e s D i r e c t i v e 9 3 / 4 2 / E E C a n d t h e P P E R e g u l a t i o n ( E U ) 2 0 1 6 / 4 2 5 T h e m a n u f a c t u r e r : A m p r i H a n d e l s g e s e l l s c h a f t m b H B e n z s t r . 1 6 2 1 4 2 3 W i n s e n ( L u h e ) G e r m a n y d e c l a r e s u n d e r i t s o w n r e s p o n s i b i l i t y t h a t A r t . N o . 0 2 2 0 1 M E D C O M F O R T f a c e m a s k s , 3 - l a y e r s , w i t h t i e - o n s , T y p I I R C o l o u r s : g r e e n , b l u e , w h i t e , p i n k , y e l l o w , l i m e , o r a n g e , p u r p l e 1 ) C o m p l i e s w i t h t h e r e q u i r e m e n t s o f A n n e x V I I o f D i r e c t i v e 9 3 / 4 2 / E E C a n d t h e h a r m o n i s e d s t a n d a r d s ; E N 1 4 6 8 3 : 2 0 1 4 . T h i s p r o d u c t i s a C l a s s I m e d i c a l d e v i c e a c c o r d i n g t o t h e c l a s s i f i c a t i o n i n A n n e x I X . a n d 2 ) c o m p l i e s w i t h t h e r e q u i r e m e n t s o f r e g u l a t i o n ( E U ) 2 0 1 6 / 4 2 5 . T h i s p r o d u c t i s a P P E o f c a t e g o r y I i n a c c o r d a n c e w i t h a t t a c h m e n t I o f t h e r e g u l a t i o n . T e c h n i c a l d o c u m e n t a t i o n i s a v a i l a b l e t o p r o v e t h i s i s a c c o r d a n c e w i t h t h e r e q u i r e m e n t s . W i n s e n , 1 3 / 0 9 / 2 0 1 8 p p a . S t e p h a n W e l z i n H e a d o f Q u a l i t y M a n a g e m e n t & O p e r a t i o n a l P u r c h a s i n g T h i s D e c l a r a t i o n o f C o n f o r m i t y i s v a l i d u n t i l 1 3 / 0 9 / 2 0 1 9 R e v i s i o n 0 1

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