METENE LIMITED

Metené Limited specialises in in-vitro diagnostic (IVD) devices focused on glucose monitoring for home use. Their portfolio includes blood glucose monitoring systems, test strips, and kits designed for electrometric glucose measurement. These devices are intended for individual patient use to measure blood glucose levels.

Metené Limited is headquartered in the United States. The company’s location is relevant for regulatory oversight and compliance, as it operates within the FDA’s jurisdiction for device authorisation.

Metené Limited’s devices fall under Class II classification according to FDA regulations. This classification applies to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, such as glucose monitoring systems that directly impact patient management of diabetes.

Yes, Metené Limited’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the supply chain, allowing healthcare providers, regulators, and patients to verify device details and compliance with FDA requirements.

Metené Limited’s devices are designed primarily for home-use glucose monitoring, including systems that combine meters with test strips or standalone strips for individual testing. Their portfolio includes both electrometric-based systems (measuring glucose via electrical current) and kits tailored for convenience, catering to patients who require frequent or self-monitored blood glucose checks.