KENEX (ELECTRO-MEDICAL) LIMITED

Kenex (Electro-Medical) Limited specializes in radiation shielding products. These include mobile and table-mounted radiation shields, protective aprons with console attachments, detector and cassette holders for imaging equipment, wall-mounted storage systems for shielding, and specialized upper-body radiation shields with adjustable joints. Their portfolio also covers track and carriage systems for radiation shielding curtains, all designed to protect patients and healthcare staff during medical imaging procedures.

Kenex (Electro-Medical) Limited is based in the United Kingdom. The company’s headquarters and manufacturing operations are located within the country, which influences its regulatory compliance and device registration processes.

Kenex’s devices are registered in two key regulatory databases: the EU’s EUDAMED system, which tracks medical devices within the European Union, and the FDA’s Unique Device Identifier (UDI) system in the United States. These registries ensure traceability and compliance with respective regulatory requirements.

Kenex’s devices fall under Class I classification in regulatory frameworks. This classification applies to low-risk medical devices that pose minimal risk to patients and users, requiring compliance with essential safety and performance requirements but typically without the need for pre-market clinical evaluation or rigorous post-market surveillance beyond standard manufacturing controls.