
Certificate Overview:
This document is a certification issued by Ente Certificazione Macchine srl to POINTEX SPA, located at Via Cecchi 30, 59100 Prato (PO), for their activities in the manufacturing of non-active, non-sterile medical devices. These include masks, suits, gowns, leggings, shoe covers, caps, and other clothing for medical personnel.
Quality Management System:
POINTEX SPA has implemented and maintains a Quality Management System that complies with the ISO 13485:2016 standard, which is specific to the medical device industry.
Certification Details:
The certificate is authorized by Antonio Bedonni, the legal representative of Ente Certificazione Macchine srl.
Ente Certificazione Macchine srl Certifica che l’Organizzazione Certify that the Organization POINTEX SPA Via Cecchi 30, 59100 Prato (PO) Per il seguente campo di attività For the following of activities Fabbricazione di dispositivi medici non attivi, non sterili, quali mascherine, tute, camici, gambali, copriscarpe, cuffie e altro vestiario per personale medico area tecnica 1.1.A Sistema di Gestione per la Qualità Quality Management System Ha implementato e mantiene un Has implemented and maintains a che soddisfa i requisiti delle seguenti norme which fulfils the requirements of the following...
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