EU → North America Device Access

DeepTrace Technologies S.R.L.

IT-MF-000027591 · Italy · Milan

DeepTrace Technologies S.R.L. is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa5

Among these devices, 5 are declared active.

Devices declared under this manufacturer

Catalogue references include 002, 014, 031, 016, 019, 021.

European nomenclature codes declared: Z11069082, Z11069092.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED5
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 GTIN3
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. DeepTrace Technologies S.R.L. was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
ITH 2412063 1issued2030-02-17
IT352911issued2031-05-21

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