EU → North America Device Access

THD S.P.A.

IT-MF-000029427 · Italy · Correggio

THD S.P.A. is registered in the European database on medical devices as a manufacturer, with 93 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa93

Most frequent device types declared: Diagnostic Line Sterile, Diagnostic Line Sterile LED, THD BIOPSY, THD Face Mask, THD MINICAM.

Among these devices, 6 are declared sterile, 1 reusable, 22 active.

Devices declared under this manufacturer

Showing 12 of 93 declared devices.

Catalogue references include 800026, 800076, 800100, 800243, 800300, 800304.

European nomenclature codes declared: T020604, G02060301, G02060302, Z12020603, Z12020405, G0308010101.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED93
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 GTIN93
Found in the U.S. device database46
Share49.5 %
⚠ The two levels disagree here. This company’s name was not found in the FDA establishment register, yet some of its devices are in the U.S. device database. The likeliest reading is that the name match failed.

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryTHD S.P.A.

What it holds in Canada

Licences on record11
Currently active0
Class 2 devices9
Class 3 devices2
First licensed2009-12-14

Licence types: Device Group Family (5), Device Family (3), System (2), Single Device (1).

Licensed under: THD DISPOSABLE ANOSCOPE AND PROCTOSCOPE, THD SURGY DISPOSABLE ANOSCOPE, THD RECTO, THD KITS, THD EVOLUTION, THD DOPPLER PROBE.

North American profile: Canada only. THD S.P.A. holds a Canadian licence but was not found in the U.S. register.

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