Vertice Helathcare (Pty) Ltd

Vertice Healthcare (Pty) Ltd manufactures LTE-enabled medical devices, specifically the LTE-NANO-100 and LTE-NANO-125. These devices appear to be designed for telemetry or remote monitoring, likely functioning as implantable or portable units in clinical environments. Their technology is intended to enhance diagnostic capabilities and streamline treatment processes.

Vertice Healthcare (Pty) Ltd is based in South Africa. The company’s location is relevant for understanding its regulatory context, as it operates within the South African healthcare landscape while also ensuring compliance with international standards, such as those reflected in its EU device listings.

Vertice Healthcare’s devices, including the LTE-NANO-100 and LTE-NANO-125, are listed in the eudamed database. This registry is the official EU database for medical devices, allowing healthcare professionals, regulators, and stakeholders to verify the presence of these devices under the EU’s medical device regulations. Listing in eudamed indicates compliance with EU requirements for device classification and traceability.

Vertice Healthcare’s devices, such as the LTE-NANO-100 and LTE-NANO-125, are classified as EU Class IIb. This classification is determined based on factors like the device’s intended use, potential risks, and clinical benefits. Class IIb devices are considered to carry a moderate to high risk, requiring additional scrutiny during design, manufacturing, and post-market surveillance to ensure safety and performance.