EU → US Device Access

Panin Srl

IT-MF-000020738 · Italy · Rovigo

Panin Srl 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 IIa7
Class IIb2

Most frequent device types declared: Filme Gyno-V 6 ovuli_ Filme Gyno-V 2 ovuli, Filme Opht-R 10 flaconi da 0.5 ml_Filme Opht-R 1 flacone 0.5 ml, Filme Olio 20 ml_ Filme Olio 2.5 ml, Filme OS 8 ml_ Filme OS 4 ml, Filme Gyno-V12 12 ovuli.

Among these devices, 1 are declared sterile.

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 EUDAMED9
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
IT332289issued2029-07-31

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