EU → North America Device Access

Italfarmacia srl

IT-MF-000013116 · Italy · Roma

Italfarmacia srl is registered in the European database on medical devices as a manufacturer, with 148 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class I144
Class IIa4

Most frequent device types declared: LINEA SKIN PEEL M, Linea SKIN PEEL COMPLEX, Linea SKIN PEEL G, Linea SKIN PEEL JESSNER, Linea SKIN-B.

Among these devices, 144 are declared sterile, 144 implantable.

Devices declared under this manufacturer

Showing 12 of 148 declared devices.

Catalogue references include ITF001/c7, ITF003/a3, ITF004/k, ITF007/g, ITF007/m1, ITF007/p.

European nomenclature codes declared: P900402, V9099.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED148
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 GTIN144
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. Italfarmacia srl was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
CVD0042250826supplemented2028-03-02
CVD0013231426supplemented2028-03-02
CVD0011231326supplemented2028-03-02
CVD0010231526supplemented2028-03-02
CVD0009231026supplemented2028-03-02
CSQ0006237126supplemented2028-03-02

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