EU → North America Device Access

GOSTOLI SRL

IT-MF-000047997 · Italy · MILANO

GOSTOLI SRL is registered in the European database on medical devices as a manufacturer, with 40 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa40

Most frequent device types declared: LE1I-212359, LE1I3-212359, MLX9I-212359, MLY8I-212359, SC3D-212359.

Devices declared under this manufacturer

Showing 12 of 40 declared devices.

Catalogue references include LE1I-212359, MLX9-212359NEU44/52, MLY8-212359MOU40/48, MLY8-212359NEU40/48, TO5-212359NE3/5, TS6-212359.

European nomenclature codes declared: M030499.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED40
Country of registrationItaly

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

Device-level evidence

Devices with a numeric GTIN40
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. GOSTOLI SRL was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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