EU → North America Device Access

AEA srl

IT-MF-000027519 · Italy · Angeli di Rosora

AEA srl is registered in the European database on medical devices as a manufacturer, with 25 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa25

Among these devices, 24 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 25 declared devices.

Catalogue references include ASH-10-WGR-B, ASH-10-WGR-P, ASN-01-B, ASN-03-B, ASN-03-P, ASN-05-P.

European nomenclature codes declared: A020102020101, A0399, A02010299, A010104.

United States market access

FDA establishment registerRegistered with FDA
Matched entryAEA SRL (IT) · FDA 3006571738
Devices in EUDAMED25
Country of registrationItaly

Device-level evidence

Devices with a numeric GTIN25
Found in the U.S. device database6
Share24.0 %

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: United States only. AEA srl is registered in the United States but was not found in the Canadian register.

Other manufacturers in Italy

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