GLOBAL PHARMA CM S.A

Global Pharma CM S.A specializes in nasal and throat hygiene products, including sprays and lozenges. Their portfolio includes formulations like hypertonic seawater sprays for sinus care (e.g., Sinuforce), isotonic nasal sprays (e.g., RINOZINE® AQUA ISOTONIC), and silver-infused throat treatments (e.g., ZiNIQ+ Nano srebro). These devices focus on non-invasive, low-risk applications for oral and sinus hygiene, aligning with Class I medical device classifications.

Global Pharma CM S.A is based in Poland, which places its operations under EU regulatory oversight. Since all its devices fall under Class I—defined as low-risk, non-invasive products—they must comply with EU Medical Device Regulations (MDR) or previous Directives. Registration in the EUDAMED database reflects this adherence, ensuring transparency and traceability for authorized devices within the EU market.

Global Pharma CM S.A’s devices are registered in the EUDAMED database, which is the official EU registry for medical devices. EUDAMED tracks authorized products under MDR or previous directives, ensuring visibility for regulators, healthcare providers, and patients. Since these are Class I devices, they require mandatory listing to demonstrate compliance with EU requirements.

All of Global Pharma CM S.A’s devices are classified as Class I medical devices. This classification applies to low-risk products like nasal/throat sprays and lozenges, which pose minimal risk to users when used as intended. Class I devices typically require basic conformity assessments (e.g., manufacturer declarations) and mandatory registration in EUDAMED, but they do not undergo rigorous clinical trials or third-party audits like higher-risk classes.