EU → North America Device Access

PHOENIX S.R.L.

IT-MF-000023426 · Italy · San Felice sul Panaro

PHOENIX S.R.L. is registered in the European database on medical devices as a manufacturer, with 447 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa447

Most frequent device types declared: Dispositivi per Infusione ed Aspirazione, Dispositivi per Infusione ed Aspirazione - ASTER-STDS, Dispositivi per Infusione ed Aspirazione - Kit PharmaGò.

Among these devices, 447 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 447 declared devices.

Catalogue references include 3282350311, 4001501001, 5404501141, 6205004021, 6215004021, 6315003021.

European nomenclature codes declared: A03010105, A03020101, A03010101, A06010103, A070103, A030499.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED447
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 GTIN447
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. PHOENIX S.R.L. was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
0425-MDR-030019-04issued2028-02-13

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