EU → North America Device Access

Jenx Limited

GB-MF-000016540 · United Kingdom · Sheffield

Jenx Limited is registered in the European database on medical devices as a manufacturer, with 459 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa459

Among these devices, 459 are declared reusable, 459 active.

Authorised representative in the Union: Advena Limited.

Devices declared under this manufacturer

Showing 12 of 459 declared devices.

Catalogue references include AT01 011-08-01, AT01 011-08-03, COVR881, COVSTZ06-09, RPRT42, RPRT69.

European nomenclature codes declared: Y180980, Y180939, V080302, Y1803, V0299, Y180999.

United States market access

FDA establishment registerRegistered with FDA
Matched entryJENX LIMITED (GB) · FDA 3003641560
Devices in EUDAMED459
Country of registrationUnited Kingdom

Device-level evidence

Devices with a numeric GTIN459
Found in the U.S. device database146
Share31.8 %

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. Jenx Limited is registered in the United States but was not found in the Canadian register.

Other manufacturers in United Kingdom

All United Kingdom manufacturers →