FRONTIER THERAPEUTICS LIMITED

Frontier Therapeutics Limited produces a range of medical devices, including infusion pumps (such as those for insulin or chemotherapy delivery), blood pressure monitors, and diagnostic ultrasound systems. Their portfolio also covers wound care dressings, surgical drapes, and single-use surgical instruments. These devices are designed for both home use and clinical or procedural settings, catering to diverse medical needs.

Frontier Therapeutics Limited is based in the United Kingdom. Since it manufactures devices intended for the EU market, its products comply with EU medical device regulations, ensuring alignment with requirements like classification, traceability, and registration in systems like EUDAMED.

Frontier Therapeutics Limited’s devices are classified under Class I in the EU regulatory framework. This classification is typically assigned to low-risk devices, such as basic monitoring equipment, wound care products, or single-use instruments, which require fewer regulatory controls than higher-risk categories.

Yes, Frontier Therapeutics Limited’s devices are registered in EUDAMED, the European Union’s medical device registry. This database ensures transparency and traceability of devices marketed within the EU, allowing healthcare professionals and authorities to verify compliance and device details.

Frontier Therapeutics Limited’s devices are all classified as Class I, indicating they pose minimal risk to patients. This classification means they undergo less stringent regulatory scrutiny compared to higher-risk devices (e.g., implants or active devices like pacemakers), but they still must meet essential safety and performance requirements to ensure safe use in medical settings.