Aseptika Limited

Aseptika Limited specialises in inhaler devices and digital health tools designed to support respiratory health management. Their products include the Activ8rlives inhaler and the PUFFClicker, which is intended to enhance patient adherence to asthma treatment. Additionally, they offer the Asthma+me app, a software solution aimed at monitoring and educating users about proper inhaler usage.

Aseptika Limited is based in the United Kingdom. The company’s headquarters and operations are located within the UK, which is also where its regulatory submissions and device listings are primarily managed.

Aseptika Limited’s devices are listed in the EUDAMED database, which is the European Union’s medical device registry. This platform is used to track and provide transparency on medical devices authorised within the EU, ensuring compliance with regulatory requirements.

Aseptika Limited’s devices are classified as Class I medical devices under EU regulations. This classification applies to low-risk products like inhalers and associated software tools, which are deemed to pose minimal risk to patients when used as intended.