EU → North America Device Access

TR Equipment AB

SE-MF-000027486 · Sweden · Tranås

TR Equipment AB is registered in the European database on medical devices as a manufacturer, with 70 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa70

Among these devices, 70 are declared active.

Devices declared under this manufacturer

Showing 12 of 70 declared devices.

Catalogue references include 05192150, 05192270, 05194005, 05194009, 0532005-4B, 0532010.

European nomenclature codes declared: Y093399, Y093312, Y093303, V08050303.

United States market access

FDA establishment registerRegistered with FDA
Matched entryTR Equipment AB (SE) · FDA 8030903
Devices in EUDAMED70
Country of registrationSweden

Device-level evidence

Devices with a numeric GTIN70
Found in the U.S. device database64
Share91.4 %

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. TR Equipment AB is registered in the United States but was not found in the Canadian register.

Other manufacturers in Sweden

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