EU → North America Device Access

G.L.O. SRL

IT-MF-000018554 · Italy · Casalecchio di Reno (BO)

G.L.O. SRL is registered in the European database on medical devices as a manufacturer, with 1 489 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa1 489

Most frequent device types declared: 105, 204/MJ, 204/MR, 204/MS, 30.

Devices declared under this manufacturer

Showing 12 of 1 489 declared devices.

Catalogue references include 105/FO, 204/MJ mis.S, 30/2 dx, mis.29, 532/F nero XXL, 570, Art. 204/MR h.10, mis.L.

European nomenclature codes declared: Y060399, Y060308, Y061209, Y060309, M030599, Y060406.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED1 489
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 GTIN1 489
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. G.L.O. SRL was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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