EU → North America Device Access

ISOMED

FR-MF-000018485 · France · Chambly

ISOMED is registered in the European database on medical devices as a manufacturer, with 22 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa22

Most frequent device types declared: Embolectomy balloon catheter single lumen, Peel-away introducer, Surgical Electric Support Arm, Vein stripper.

Among these devices, 8 are declared sterile, 14 active.

Devices declared under this manufacturer

Showing 12 of 22 declared devices.

Catalogue references include 2004102, 432005, BCS900R, BSC650F, BSC850F, BSC850R.

European nomenclature codes declared: V0899, A01010302, C01901901, C0503, C019002.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED22
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 GTIN22
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: Neither register. ISOMED was not found in either the U.S. or the Canadian register.

Other manufacturers in France

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