EU → North America Device Access

ASA S.r.l.

IT-MF-000007966 · Italy · ARCUGNANO (VI)

ASA S.r.l. is registered in the European database on medical devices as a manufacturer, with 59 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb36
Class IIa23

Most frequent device types declared: F9000173, F9000203, F9000219, F9020073, F9020118.

Among these devices, 53 are declared active.

Devices declared under this manufacturer

Showing 12 of 59 declared devices.

Catalogue references include F9000219, F9000276, F9000280, F9000292, F9000312, F9000315.

European nomenclature codes declared: Z120615, Z120606.

United States market access

FDA establishment registerRegistered with FDA
Matched entryASA S.R.L. (IT) · FDA 3004724437
Devices in EUDAMED59
Country of registrationItaly

Device-level evidence

Devices with a numeric GTIN59
Found in the U.S. device database4
Share6.8 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryASA S.R.L.

What it holds in Canada

Licences on record4
Currently active0
Class 3 devices4
First licensed2012-06-08

Licence types: Device Group Family (3), System (1).

Licensed under: MPHI MLS LASER THERAPY, M6, M7, M-HI.

North American profile: Both markets. ASA S.r.l. is registered in both the United States and Canada.

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