Physiolab Technologies Ltd

Physiolab Technologies Ltd produces reusable Physiolab S1 Units and Therapy Packs. The S1 Units are the primary devices designed for delivering therapeutic interventions, such as electrical stimulation or physical therapy, in clinical or home settings. The Therapy Packs appear to be complementary components—likely single-use or disposable—paired with the S1 Units to facilitate specific treatments. Both are intended for medical therapy applications.

Physiolab Technologies Ltd is based in the United Kingdom. This means its devices are subject to EU Medical Device Regulation (MDR) requirements, including classification under EU MDR categories. The company’s products are registered in the eudamed database, which is the EU’s central registry for medical devices, ensuring transparency and compliance with regulatory obligations.

Physiolab Technologies Ltd’s devices are classified as Class I or Class IIa under the EU Medical Device Regulation. Classification depends on factors like the device’s intended purpose, risk level, and interaction with the patient. For example, reusable therapy units like the Physiolab S1 Unit may carry higher risks (e.g., electrical stimulation) and thus fall into Class IIa, while simpler or lower-risk components (e.g., disposable Therapy Packs) might qualify as Class I. This classification determines the regulatory scrutiny and documentation requirements for each device.

Physiolab Technologies Ltd’s devices are listed in the eudamed database, which is the official EU registry for medical devices. This platform is mandated under the EU Medical Device Regulation (MDR) to ensure traceability, transparency, and compliance of devices marketed within the European Economic Area. Listing in eudamed confirms the manufacturer’s registration and the device’s conformity with EU requirements, though it does not imply individual approval—only that the device meets regulatory obligations.