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CERTIFICATO N. 0662.2025

CERTIFICATO N. 0662.2025

Product catalog summary
Certificate Overview: This document certifies that HC Italia SRL operates a Quality Management System compliant with ISO 13485:2016 standards. The certification covers the design, manufacturing, and marketing of active medical devices for urological diagnostics, as well as the marketing of medical devices for urology and proctology.
Certification Details: The initial certification was granted on January 21, 2014, by another certification body. The current issue of the certificate was made on November 19, 2025, and it is set to expire on January 20, 2029.
Compliance and Validity: The certificate's validity is contingent upon annual audits and a complete reassessment of the management system every three years. Verification of the certificate's validity can be done by scanning the provided QR-Code.
Contact Information: The certification was issued by IMQ S.p.A., located at Via Quintiliano, 43, 20138 Milano, Italy. HC Italia SRL is based at Via Serio 10, 20073 Opera (MI), Italy.
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Catalog excerpts

CERTIFICATO N. 0662.2025-1

IQNET The International Certification Network SI CERTIFICA CHE IL SISTEMA DI GESTIONE PER LA QUALITA' DI WE HEREBY CERTIFY THAT THE QUALITY MANAGEMENT SYSTEM OPERATED BY VIA SERIO 10 - 20073 OPERA (MI) Italy UNITA' OPERATIVE/OPERATIVE UNITS VIA SERIO 10 - 20073 OPERA (MI) Italy E' CONFORME ALLA NORMA /IS IN COMPLIANCE WITH THE STANDARD Progettazione, fabbricazione e immissione in commercio a proprio nome di dispositivi medici attivi per la diagnostica urologica. Commercializzazione di dispositivi medici per urologia e proctologia Design, manufacturing and placing on the market under its own name of active medical devices for urological diagnostics. Marketing of medical devices for urology and proctology Ulteriori informazioni riguardanti l'applicabilita dei requisiti ISO 13485:2016 possono essere ottenute consultando l'organizzazione Further clarifications regarding the applicability of ISO 13485:2016 requirements may be obtained by consulting the organization IL PRESENTE CERTIFICATO E' SOGGETTO AL RISPETTO DEL REGOLAMENTO PER LA CERTIFICAZIONE DEI SISTEMI DI GESTIONE THE USE AND THE VALIDITY OF THE CERTIFICATE SHALL SATISFY THE REQUIREMENTS OF THE RULES FOR CERTIFICATION OF MANAGEMENT SYSTEMS PRIMA CERTIFICAZIONE FIRST CERTIFICATION EMISSIONE CORRENTE CURRENT ISSUE IMQ S.p.A. - VIA QUINTILIANO, 43 - 20138 MILANO ITALY Management Systems Division - Flavio Ornago La data di prima certificazione e riferita al rilascio da parte di altro organismo First certification date is related to issue date of another Certification Body CISQ 6 la Federazione Italians di Organismi di Certificazione dei sistemi di gesbone aziendale CISQ is the Italian Federation of management system Certification Bodies. La validita del certificate, subordinata a sorveglianza annuale e riesame completo del Sistema di Gestione con periodicita triennale, puo essere verificata inquadrando il QR-Code. The validity of the certificate, submitted to annual audit and a reassessment of the entire management System within three years, can be verified by scanning the QR-Code.

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