EU → North America Device Access

Tribun Health

FR-MF-000002560 · France · PARIS

Tribun Health is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Devices declared under this manufacturer

Catalogue references include CaloPix 5.2.10, CaloPix 5.2.12, CaloPix 5.2.13, CaloPix 5.2.2, CaloPix 5.2.9, CaloPix 6.2.0.

European nomenclature codes declared: W0202050392.

United States market access

FDA establishment registerRegistered with FDA
Matched entryTRIBUN HEALTH (FR) · FDA 3039404341
Devices in EUDAMED6
Country of registrationFrance

Device-level evidence

Devices with a numeric GTIN1
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryTRIBUN HEALTH

What it holds in Canada

Licences on record2
Currently active0
Class 2 devices2
First licensed2014-11-26

Licence types: Single Device (2).

Licensed under: CALOPIX, TELESLIDE.

North American profile: Both markets. Tribun Health is registered in both the United States and Canada.

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