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Zaoli Med

Zaoli Med

Surgical Face Mask

DICHIARAZIONE-CONFORMITA CE-Mascherina-Z-UNI-1803-ZM

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Prodotto: Mascherina chirurgica Tipo IIR
Modello: Z-UNI-1803-ZM
Fabbricante: ZM Design. srl
Indirizzo del fabbricante: Via Gianni Cozzil, Santo Stefano al Mare, (IM)
Anno: 2020

Il fabbricante dichiara sotto la propria responsabilita che il dispositivo medico sopra designato e conforme ai requisiti essenziali della seguente direttiva dell’Unione Europea:

Direttiva: MDD 93/42/CE del 14 giugno 1993 emendata dalla direttiva 2007/47/CE e dal regolamento UE 2017/745

Il fabbricante si impegna a conservare e a tenere a disposizione delle autorita competenti presso la propria sede la documentazione tecnica, come da allegato VII della direttiva citata, per un periodo di 5 anni (cinque) dalla messa in commercio di questo dispositivo medico classe I e dichiara che:

Il prodotto “Mascherina chirurgica Tipo IIR Modello: Z-UNI-1803-ZM” é da considerarsi come “Dispositivo Medico destinato alla prevenzione di una malattia” appartenente alla Classe I.

Il fabbricante ha istituito una procedura sistematica per valutare l’esperienza acquisita nell’uso del dispositivo nella fase successiva alla produzione, nonché a mantenere un sistema appropriato cui ricorrere per applicare le misure correttive eventualmente necessarie.

Data di validita: 21/10/2020

Luogo: Santo Stefano al mare (IM)
Data 26/05/2021
Firma Legale Rappresentante
Giuseppe Zaoli

ZM Design s.r.l. - Via Gianni Cozzi, 1 - 18010 S. Stefano al Mare (IM) Tel. +39 0184 481115 - info@zaolimed.com

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