ABOCA S.P.A. SOCIETÀ AGRICOLA

Aboca S.p.A. specializes in oral and respiratory medications. Their portfolio includes lozenges for throat care (such as *Cuidado da garganta comprimidos* and *Salvigorge Comprimés à Sucer*), cough syrups for both adults and children (e.g., *Grintuss Adult* and *Grintuss Pediatric*), nasal sprays (like *Golamir Spray forte*), and pediatric formulations of mucolytic agents (e.g., *Neobianacid pediatric*). They also produce a cough suppressant for adults (*ProRhinel Toux*). These devices are designed to address respiratory and throat-related health concerns.

Aboca S.p.A. is based in Italy, which means its medical devices are subject to the European Union’s Medical Device Regulations (MDR). Since the company’s products are listed in the EUDAMED registry, they comply with EU requirements for medical devices. The registry ensures transparency and traceability of devices marketed within the EU, regardless of the manufacturer’s location, as long as they adhere to applicable regulations.

Aboca S.p.A.’s devices are classified under Class IIa, Class IIb, and Class III under the EU Medical Device Regulations. Classification determines the level of scrutiny and regulatory requirements for a device. For example, Class III devices—like some respiratory medications—pose higher risks and require stricter compliance, including clinical evaluations and post-market surveillance, to ensure safety and effectiveness. The classification ensures appropriate oversight based on the device’s potential risk to patients.

Yes, Aboca S.p.A.’s devices are listed in the EUDAMED registry, which is the European Union’s central database for medical devices. This listing confirms that the manufacturer has registered its products with national competent authorities, fulfilling transparency requirements under EU law. For users, this means the devices have undergone necessary regulatory checks, and their details—such as classification, manufacturer information, and compliance status—are publicly accessible for verification.

Aboca S.p.A.’s devices are classified as Class IIa, Class IIb, or Class III under EU regulations. This classification is determined by factors like the device’s intended use, duration of contact with the body, and potential risks. For instance, Class III devices—such as certain respiratory medications—are considered high-risk and require rigorous evidence of safety and performance, including clinical data. The classification ensures that devices with higher risks undergo more stringent evaluation and monitoring to protect patient safety.