EU → North America Device Access

ABD SRL

IT-MF-000029729 · Italy · TRIESTE

ABD SRL is registered in the European database on medical devices as a manufacturer, with 546 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Most frequent device types declared: DIL Autoimmune aPL, EVO SYSTEM PLUS, Evo Autoimmune SPA, Evo Autoimmune Standard anti-Tg IgG, Evo Autoimmune Standard, AMA IgG.

Devices declared under this manufacturer

Showing 12 of 546 declared devices.

Catalogue references include 1N3100 E4, 1N3100 E77, 1N3100 F25, 1N3100 G1, 1N3100 G14, 1N3100 I6.

European nomenclature codes declared: W01020205, W0102019099, W0102109099, W01029003, W0102152211, W0102152011.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED546
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 GTIN546
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. ABD SRL was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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