EU → North America Device Access

Med-Logix Srl

IT-MF-000026525 · Italy · Roma

Med-Logix Srl is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb4
Class IIa1

Most frequent device types declared: ALBA 4D, ALBA ON, ALBA ON 1000.

Among these devices, 5 are declared active.

Devices declared under this manufacturer

Catalogue references include ALBA 4D, ALBA ON 1000, ALBA ON 4000A, ALBA ON 4000D, ALBA-OPTIX.

European nomenclature codes declared: Z1204021501, Z120499.

United States market access

FDA establishment registerRegistered with FDA
Matched entryMedlogix (US) · FDA 3031256651
Devices in EUDAMED5
Country of registrationItaly

Device-level evidence

Devices with a numeric GTIN5
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: United States only. Med-Logix Srl is registered in the United States but was not found in the Canadian register.

Notified body certificates

CertificateStatusExpiry
ITH 1343526 1supplemented2028-10-16

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