PRANARÔM ESPAÑA S.L.U

PranaRôm España S.L.U manufactures inhalation devices primarily for aromatherapy and allergy relief. This includes portable aromatherapy inhalers like AROMAFORCE and AROMAFORCE JUNIOR, which deliver essential oils for inhalation. It also produces devices such as ALLERGOFORCE and AFOMAFORCE EXTRA for allergen immunotherapy, as well as a handheld device called PRANABB for respiratory wellness, including humidification and inhalation therapy. These products are designed for personal or home use.

PranaRôm España S.L.U is based in Spain and operates within the European Union regulatory framework. Its devices are intended for use in the EU, where they must comply with either the EU Medical Device Regulations (MDR) or the Medical Device Directive (MDD), depending on their conformity date. This ensures alignment with EU safety and performance standards.

PranaRôm España S.L.U’s devices are listed in the eudamed database, the official EU registry for medical devices. This registration ensures traceability and transparency, allowing healthcare professionals, regulators, and patients to verify the device’s compliance with EU requirements. All listed devices are accounted for in this system.

PranaRôm España S.L.U’s devices fall under Class IIa classification according to EU medical device regulations. This classification applies to devices with a moderate risk profile, requiring compliance with specific design controls, clinical evaluations, and conformity assessment procedures to ensure safety and performance. The classification ensures appropriate oversight while balancing regulatory burden with innovation.