EU → North America Device Access

HELIOSCOPIE

FR-MF-000009506 · France · VIENNE

HELIOSCOPIE is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa8

Most frequent device types declared: Gastric Tube, Non Sterile Gastric Tube.

Among these devices, 4 are declared sterile.

Devices declared under this manufacturer

Catalogue references include HSG 36Fr, HSG 36Fr B, HSG 39Fr, HSG 39Fr B, NS HSG 36Fr, NS HSG 36Fr B.

European nomenclature codes declared: G020502,G020599.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED8
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 GTIN8
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryHELIOSCOPIE

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

Other manufacturers in France

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