EU → North America Device Access

T.H. SERVICE SRL

IT-MF-000028023 · Italy · SAN GENNARO VESUVIANO

T.H. SERVICE SRL is registered in the European database on medical devices as a manufacturer, with 80 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa80

Most frequent device types declared: Reusable technical fabric gowns and coveralls for sterilization kits f.

Devices declared under this manufacturer

Showing 12 of 80 declared devices.

Catalogue references include CA 119, TS 535, TS 550, TS 569, TS 599, TS 604.

European nomenclature codes declared: T020199, T020402, T020401.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED80
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 GTIN80
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. T.H. SERVICE SRL was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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