EU → North America Device Access

GN MED s.r.l.

IT-MF-000027922 · Italy · Ravenna

GN MED s.r.l. is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb8
Class IIa1

Most frequent device types declared: DT-1004, LASERIX PH12, LASERIX PH3, Laserix PhP, PH10.

Among these devices, 8 are declared active.

Devices declared under this manufacturer

Catalogue references include DT-1004, FT-245, LASERIX PH12, LASERIX PH3, LASERIX PHP, LASERIX PRO.

European nomenclature codes declared: Z120602, Z120615, Z12069099.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED9
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 GTIN9
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. GN MED s.r.l. was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
ITH 2412060 1supplemented2028-11-15

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