EU → North America Device Access

DWS srl

IT-MF-000013530 · Italy · Thiene (VI)

DWS srl is registered in the European database on medical devices as a manufacturer, with 37 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa37

Most frequent device types declared: IRIX MAX, IRIX PLUS, TEMPORIS.

Devices declared under this manufacturer

Showing 12 of 37 declared devices.

Catalogue references include 10200143, 10200246, 10200253, 10200254, 10200279, 10200280.

European nomenclature codes declared: Q010699.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED37
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 GTIN37
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. DWS srl was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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