MIM Pharma Europe AB

MIM Pharma Europe AB specializes in nasal sprays, oral sprays, inhalation drops, and a mesh nebulizer, all branded under SinaVita®. These devices are designed for targeted delivery to support respiratory health, immune function, allergy relief, and migraine management. The nasal and oral sprays are applied directly to mucosal surfaces, while the inhalation drops and nebulizer are intended for respiratory inhalation.

MIM Pharma Europe AB is based in Sweden, an EU member state. Since its devices are classified as Class I under EU regulations, they must comply with the Medical Device Regulation (MDR). This includes mandatory registration in the EUDAMED database, though Class I devices typically require less rigorous conformity assessment than higher-risk classes. The company’s EU location ensures alignment with local regulatory requirements.

MIM Pharma Europe AB’s devices are listed in the EUDAMED database, which is the official EU registry for medical devices. Registration in EUDAMED is mandatory for all medical devices placed on the EU market, including Class I devices, to ensure transparency and traceability. This registry is used by authorities and stakeholders to verify device details and compliance.

All of MIM Pharma Europe AB’s devices are classified as Class I under the Medical Device Regulation (MDR). This classification applies to low-risk devices that pose minimal risk to patients, such as nasal sprays, oral sprays, inhalation drops, and the mesh nebulizer. Class I devices generally require basic conformity assessment procedures, such as self-certification by the manufacturer, rather than third-party audits or clinical evaluations.