EU → North America 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 IIb2
Class IIa7

Most frequent device types declared: Filme Gyno-V 6 ovuli_ Filme Gyno-V 2 ovuli, Filme Gyno-V12 12 ovuli, Filme Nasale 20 ml_ Filme Nasale 7 ml, Filme OS 8 ml_ Filme OS 4 ml, Filme OTO 20 ml_ Filme OTO 7 ml.

Among these devices, 1 are declared sterile.

Devices declared under this manufacturer

Catalogue references include FEGYNO-V, FEGYNO-V12, FEOLIO, FEOPHTR, FEOS, FEOTO.

European nomenclature codes declared: M9002, U0803, Q02030206, Q0199, Q03040201, V901001.

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. Panin Srl was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
IT332289issued2029-07-31

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