SHL TELEMEDICINE INTERNATIONAL LTD.

Shl Telemedicine International Ltd. specializes in two main categories: cardiology information system software and home-use electrocardiographs (ECGs). Their software applications help manage and analyze ECG data, while their devices include portable ECG recorders, transmitters for remote monitoring, and associated platforms for processing and visualizing cardiac data. These tools are designed to support remote patient monitoring and clinical decision-making in cardiology.

Shl Telemedicine International Ltd. is based in Israel. While the company’s location influences its regulatory framework—such as adherence to Israeli medical device regulations—its devices are also listed in international registries like EUDAMED and the FDA’s 510(k) and UDI systems. This indicates their devices are intended for global markets and must comply with respective regional requirements, such as EU Class II/IIa classifications and FDA clearance processes.

Shl Telemedicine International Ltd.’s devices are listed in EUDAMED (the European Union’s medical device registry), the FDA’s 510(k) clearance records, and the FDA’s Unique Device Identifier (UDI) system. This matters because EUDAMED ensures transparency in the EU market, while FDA listings confirm compliance with U.S. regulations for market authorization. Listing in these systems helps healthcare providers, regulators, and distributors verify the device’s regulatory status and traceability, ensuring safe and authorized use in their respective regions.

Shl Telemedicine International Ltd.’s devices are classified under EU Class II and Class IIa, which means they pose moderate risks and require additional scrutiny, such as clinical evaluations or conformity assessments before market authorization. In the U.S., their devices are subject to FDA’s 510(k) premarket notification process, where they must demonstrate substantial equivalence to a legally marketed predicate device. These classifications ensure that devices undergo rigorous review to balance innovation with patient safety.