Certifications
MESA Italia Srl complies with the latest standards for quality and complies with the strictest international criteria in the production of both class IIA and IIB medical devices by keeping its management system constantly updated in accordance with UNI CEI EN ISO 13485:2021, UNI EN ISO 9001:2015 and MDSAP (Medical Device Single Audit Program) standards. Therefore, the organization has obtained marketing authorization for its devices from entities in the 5 member countries:
UNI EN ISO 13485:2016
UNI EN ISO 9001:2015
MDSAP
FDA
(United States of America)
ANVISA
(Brazil)
MHLW
(Japan)
HEALTH CARE MINISTRY
(Canada)
therapeutic good administration
(Australia)
The company also has CE markings in accordance with Directive 93/42/EEC (MDD) and Regulation (EU) 2017/745 (MDR) for the sale of all medical devices in European Union member countries, issued by Notified Body ICIM SpA.
- CE ICIM (MDD) for prosthetic components, dental implants and surgical instrumentation
- CE ICIM (MDR) for dental alloys
- Letter of Confirmation (MDR)
From the technical documentation produced for CE marking, Mesa Italia Srl has obtained several sales licenses in many other countries including:
- Eastern Europe (Russia, Ukraine, Belarus…)
- Asia (China, South Korea, Kazakhstan, Malaysia, Turkmenistan…)
- Maghreb (Egypt, Tunisia and Algeria)
- South America (Colombia, Honduras, Argentina and Peru)
