EU → US 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-F, Linea SKIN-B, Linea SKIN-R, Linea SKIN-OX, Linea SKIN-COLIN.

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

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED148
Country of registrationItaly
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

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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