EU → North America Device Access

Vision RT Ltd.

GB-MF-000010499 · United Kingdom · London

Vision RT Ltd. is registered in the European database on medical devices as a manufacturer, with 56 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb43
Class IIa13

Most frequent device types declared: DoseRT Camera.

Among these devices, 50 are declared active.

Authorised representative in the Union: Oticon A/S.

Devices declared under this manufacturer

Showing 12 of 56 declared devices.

Catalogue references include AlignRT InBore 7.0, AlignRT InBore Accuray Fibre Hub, Calibration Plate, Horizon camera, SafeID, SimRT 6.5.

European nomenclature codes declared: Z11019099, Z11019080, V9099.

United States market access

FDA establishment registerRegistered with FDA
Matched entryVision RT Ltd (GB) · FDA 3014428919
Devices in EUDAMED56
Country of registrationUnited Kingdom

Device-level evidence

Devices with a numeric GTIN56
Found in the U.S. device database47
Share83.9 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryVISION RT LTD

What it holds in Canada

Licences on record1
Currently active0
Class 3 devices1
First licensed2015-07-08

Licence types: System (1).

Licensed under: ALIGNRT.

North American profile: Both markets. Vision RT Ltd. is registered in both the United States and Canada.

Other manufacturers in United Kingdom

All United Kingdom manufacturers →