EU → North America Device Access

Texray AB

SE-MF-000042840 · Sweden · Göteborg

Texray AB is registered in the European database on medical devices as a manufacturer, with 24 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa24

Devices declared under this manufacturer

Showing 12 of 24 declared devices.

Catalogue references include PS-1150, PS-3350, PS-3450, TS-1050, TS-1550, TS-2050.

European nomenclature codes declared: T0299.

United States market access

FDA establishment registerRegistered with FDA
Matched entryTEXRAY AB (SE) · FDA 3017636959
Devices in EUDAMED24
Country of registrationSweden

Device-level evidence

Devices with a numeric GTIN24
Found in the U.S. device database24
Share100.0 %

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: United States only. Texray AB is registered in the United States but was not found in the Canadian register.

Other manufacturers in Sweden

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