Callegari 1930 S.p.a. - Point of Care products for the medical, wellness and skin health sector

QUALITY CERTIFICATION

Callegari’s Quality Management System is certified since 2001 according to ISO standards 9001:94 and 46001:1996

At present, the Quality Management System is certified according to standards ISO 9001:2000 and 13485:2004 (which has replaced the EN 46001:19996). The ISO 13485 specifies additional requirements in order to achieve regulatory compliance in the medical devices industries. For customers and distributors, certification according to international standard ISO 13485 guarantee that products and services provided fulfil regulatory requirements

CE MARKING
All products are fully CE marked, according to the following European Directives

89/336/EEC (Electro Magnetic compatibility Directive)
73/23/EE, 93/68/CE (Low Voltage Directives)
98/79/CE (IVDD Directive)

CE marking is mandatory for placing the product on the European market and ensures that the item meets all the essential safety requirements of all applicable EU directives.

Instruments and reagents are certified for self testing use according to annex III.6 of EEC directive 98/79
Annex III.6 adds specific requirements for conformity assessment of self-testing equipments.
In order to obtain this CE marking, an external body, referred to as a notified body, has to review the product and certify that the device can be used in point of care sites where often employed by non-skilled staff.
In that case, the conformity to the EC directive is shown by a CE mark with a number. Products on the market without this number have simply obtained the basic CE mark covering essential safety compliances.

Callegari S.p.A. is registered at the Italian Health Ministry as a Manufacturer of In-Vitro Diagnostic Devices, in accordance to the EC directive 98/79.

FOREIGN REGISTRATIONS

The products pertaining to the CR2000 and CR3000 range are registered as medical devices in various foreign countries including China, Singapore, Korea and Malaysia.

Cosmetic equipments have obtained free sale certificates on various countries around the world.