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IVES-System Sp. z o.o.

Active in EUDAMED

Polandfrom EUDAMED address EUDAMED SRN PL-MF-000046929

Devices
0
Registrations
EUDAMED

No devices from this company are in the catalogue yet.

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor

Company details

EUDAMED SRN
PL-MF-000046929
EU VAT number
701-051-34-95
EUDAMED status
Active
EUDAMED registered name
IVES-System Sp. z o.o.
EUDAMED abbreviated name
IVES-System Sp. z o.o.
PRRC contact
Mateusz Flis(public in EUDAMED)

From the company website

Read 18 Oct 2026

At IVES-system we have implemented a quality management system for medical devices in accordance with ISO standard 13485 for design, the production, sale and service of medical software for viewing and analyzing medical research. The management system is certified by TUV NORD Polska. During design and production in Visium Viewer, among others, standards were used: IEC 62304, IEC 62366- 1:2015-7 and ISO 14971:2012. The product is CE marked, certified by TUV Nord Polska as a medical device with function measuring class II a.

Translated from the manufacturer's own website. Source