EU → North America Device Access

EUROSILICONE SAS

FR-MF-000008947 · France · APT Cedex

EUROSILICONE SAS is registered in the European database on medical devices as a manufacturer, with 591 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa204
Class I335
Class IIb52

Most frequent device types declared: ES.16/300, ES.261/160, ES.28/100, ES.281/240, ES.281/280.

Among these devices, 588 are declared sterile, 427 implantable.

Devices declared under this manufacturer

Showing 12 of 591 declared devices.

Catalogue references include 16/300, 261/160, 28/100, 802/180N, AS-LR1/110, AS-MR3/395.

European nomenclature codes declared: P0699, P0601010202, P0601020202, P0601010201, Y062499, P900105.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED591
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 GTIN591
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. EUROSILICONE SAS was not found in either the U.S. or the Canadian register.

Other manufacturers in France

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