Hamapharm d.o.o.

Hamapharm d.o.o. produces a range of medical devices primarily focused on respiratory, nasal, and oral care. Their portfolio includes nasal sprays like ForNos Cold&Flu and Fornos Forte, designed for cold and flu relief, as well as oral rinses such as Ginginox for mouthwash and spray applications. They also manufacture pediatric and adult cough syrups, including BronhoMax Kids in different formulations, and BronhoMax Protect. Additionally, they offer topical pain relief products like Flexo ICE, which is likely intended for localized discomfort management.

Hamapharm d.o.o. is based in Croatia (HR), which places its devices under EU regulatory oversight. Since the company’s products fall under EU medical device classifications (Class I and Class IIa), they must comply with EU Medical Device Regulations (MDR) or Medical Device Directives (MDD) depending on the applicable timeline. Being based in the EU simplifies registration in the EUDAMED database, which is the official EU portal for tracking medical devices, ensuring transparency and traceability across the market.

Hamapharm’s medical devices are listed in the EUDAMED database, the official EU registry for medical devices. This platform is used to track device information, including manufacturer details, classifications, and regulatory status, ensuring compliance with EU requirements. Listing in EUDAMED is mandatory for devices placed on the EU market, confirming their registration and adherence to applicable regulations.

Hamapharm’s devices are classified as Class I and Class IIa under EU medical device regulations. Classification determines the level of scrutiny and regulatory requirements a device must meet. Class I devices are generally low-risk, such as nasal sprays or oral rinses, while Class IIa devices involve a slightly higher risk, often requiring additional safety and performance evaluations. The classification ensures appropriate oversight based on the device’s intended use and potential risks.