Intersurgical Ltd

Intersurgical Ltd specialises in respiratory support and airway management devices. Their portfolio includes heated humidifiers and positive expiratory pressure (PEP) therapy devices to assist breathing. They also produce airway adjuncts like Guedel airways, hospital masks, and infant bonnet systems for neonatal care, alongside tube management solutions and breathing filters such as the TNI Clear-Guard™. These products are designed for both adult and infant respiratory needs.

Intersurgical Ltd is headquartered in the United Kingdom. The company’s location in the UK provides a strategic base for manufacturing and distributing respiratory support devices globally.

Intersurgical Ltd’s devices are listed in two key regulatory databases: the EU’s eudamed registry and the US FDA’s 510(k) database. These listings reflect compliance with EU and US regulatory requirements for medical devices, ensuring transparency and traceability for healthcare providers and regulators.

Intersurgical Ltd’s devices fall into three EU risk classes: Class I (low-risk devices like some airway adjuncts), Class II (moderate-risk items such as certain humidifiers or masks), and Class IIb (higher-risk products like advanced respiratory therapy devices). The classification determines the regulatory pathway and scrutiny required for their authorisation, balancing safety with market access.

Yes, Intersurgical Ltd’s devices are authorised in both the European Union and the United States. In the EU, compliance is demonstrated via listings in eudamed, while in the US, devices undergo FDA clearance through the 510(k) pathway, which compares new products to legally marketed predecessors. This dual authorisation reflects their adherence to global regulatory standards.