EU → North America Device Access

DOSISOFT

FR-MF-000014706 · France · CACHAN

DOSISOFT is registered in the European database on medical devices as a manufacturer, with 10 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb6
Class IIa4

Among these devices, 10 are declared active.

Devices declared under this manufacturer

Catalogue references include EP1001, EP1011, IS1001, MU1001, PL1100, TK2010, TK2020.

European nomenclature codes declared: Z11019092, Z11020392, Z11010401, Z11029092.

United States market access

FDA establishment registerRegistered with FDA
Matched entryDOSISOFT (FR) · FDA 3009302839
Devices in EUDAMED10
Country of registrationFrance

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryDOSISOFT

What it holds in Canada

Licences on record3
Currently active0
Class 2 devices3
First licensed2016-02-02

Licence types: Single Device (2), Device Family (1).

Licensed under: LOGICIEL EPIGRAY, THINKQA SUITE/EPIBEAM, THINKQA.

North American profile: Both markets. DOSISOFT is registered in both the United States and Canada.

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