EU → North America Device Access

SYNTESYS S.R.L.

IT-MF-000027856 · Italy · TEOLO (PD)

SYNTESYS S.R.L. is registered in the European database on medical devices as a manufacturer, with 32 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa24

Most frequent device types declared: 331225, 331250, 380101 - Tampone secco con asta in legno e punta in cotone, in provett, 380201: Tamponi secchi asta in plastica, punta in viscosa, in provetta, 380301: Tamponi secchi con asta in alluminio, punta fine in viscosa, i.

Among these devices, 9 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 32 declared devices.

Catalogue references include 331225, 380201, 390472, 390488, 390493, 391470.

European nomenclature codes declared: V0812,Y091299, W05010203, A1102, A1101.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED32
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 GTIN32
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. SYNTESYS S.R.L. was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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