EU → North America Device Access

ASG Superconductors S.p.A.

IT-MF-000029567 · Italy · Genova

ASG Superconductors S.p.A. 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 IIa5

Most frequent device types declared: 03-2000-00, MROpen EVO V4, MRopen EVO.

Among these devices, 5 are declared active.

Devices declared under this manufacturer

Catalogue references include 03-2000-00 V.4, 03-2000-00 V12, 03-2000-00 V4, 03-2000-00 V8, 03-4000-00 V1.

European nomenclature codes declared: Z11050102.

United States market access

FDA establishment registerRegistered with FDA
Matched entryASG Superconductors S.p.A. (IT) · FDA 3004994584
Devices in EUDAMED5
Country of registrationItaly

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryASG SUPERCONDUCTORS S.P.A

What it holds in Canada

Licences on record2
Currently active0
Class 2 devices2
First licensed2023-08-17

Licence types: Single Device (2).

Licensed under: MROPEN EVO, MROPEN EVO (V12).

North American profile: Both markets. ASG Superconductors S.p.A. is registered in both the United States and Canada.

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