EU → North America Device Access

Telea Electronic Engineering S.r.l.

IT-MF-000009973 · Italy · SANDRIGO

Telea Electronic Engineering S.r.l. is registered in the European database on medical devices as a manufacturer, with 13 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb13

Among these devices, 2 are declared sterile, 13 active.

Devices declared under this manufacturer

Showing 12 of 13 declared devices.

Catalogue references include 2501002, 2501011, 2501019, 2501023, 2501034, 2501035.

European nomenclature codes declared: Z12010905, Q03010101, L180301.

United States market access

FDA establishment registerRegistered with FDA
Matched entryTELEA ELECTRONIC ENGINEERING S.R.L. (IT) · FDA 3010701628
Devices in EUDAMED13
Country of registrationItaly

Device-level evidence

Devices with a numeric GTIN13
Found in the U.S. device database5
Share38.5 %

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: United States only. Telea Electronic Engineering S.r.l. is registered in the United States but was not found in the Canadian register.

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