EU → North America Device Access

INTRASENSE

FR-MF-000001551 · France · MONTPELLIER

INTRASENSE is registered in the European database on medical devices as a manufacturer, with 61 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa61

Most frequent device types declared: DUOnco liver, DUOncoPancreas, Liflow, Myrian, Myrian 2.9.

Among these devices, 61 are declared active, 59 with a measuring function.

Devices declared under this manufacturer

Showing 12 of 61 declared devices.

Catalogue references include Liflow 2.0, Myrian® 2.12 : XM-MR, Myrian® 2.12 : XP-Colon, Myrian® 2.12 : XP-Prostate, Myrian® 2.13 : XM-CT, Myrian® 2.13 : XP-BrainPerfusionCT.

European nomenclature codes declared: Z11069005, Z11069082.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED61
Country of registrationFrance

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN60
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryINTRASENSE

North American profile: Canada only. INTRASENSE holds a Canadian licence but was not found in the U.S. register.

Other manufacturers in France

All France manufacturers →