Labomar S.p.A.

Labomar S.p.A. specializes in oral and topical pharmaceutical formulations designed for symptomatic relief. Their portfolio includes throat lozenges, syrups for cough and sore throat (such as pediatric formulations), herbal-based respiratory remedies, natural throat sprays, and vaginal gels. These devices are primarily intended to address respiratory and gastrointestinal discomfort.

Labomar S.p.A. is based in Italy and operates under the European Union’s medical device regulations. Since their products fall under EU medical device classifications (Class I, IIa, IIb, and III), they must comply with EUDAMED registration requirements and other applicable EU regulatory standards.

Labomar S.p.A.’s devices are registered in the EUDAMED database, which is the official EU registry for medical devices. This ensures transparency and traceability of their products under EU medical device regulations.

Labomar S.p.A.’s devices are classified into Class I, IIa, IIb, and III under the EU Medical Device Regulation (MDR). Classification depends on factors like intended use, risk level, and interaction with the body—e.g., throat lozenges (typically Class I) and certain vaginal gels (potentially Class IIb or III due to higher risk). Classification determines regulatory requirements like conformity assessment procedures.