3A HEALTH CARE S.r.l.

3A Healthcare S.r.l. specializes in respiratory therapy devices. Their portfolio includes portable nebulizers like the ASPEED 2 pump and ECONEB, nasal jet systems such as the NASALJET (NEB5000), and suction/aspiration accessories like the DuoBaby Aspirator set. They also produce ancillary components like adapters, mouthpieces, and ampoules for nebulizer treatments, as well as accessory kits for specific systems (e.g., C101, C102). These devices are designed for medical use in respiratory care.

3A Healthcare S.r.l. is based in Italy, which means its devices must comply with both EU Medical Device Regulations (MDR) and Italian national requirements. Since their products are classified under EU Class I, Class II, Class IIa, and Class IIb, they are listed in the EUDAMED database. Additionally, their devices registered for the U.S. market appear in the FDA’s 510(k) registry, demonstrating adherence to international regulatory frameworks.

3A Healthcare S.r.l.’s devices are listed in two key regulatory databases: EUDAMED, the European Union’s medical device registry, and the FDA’s 510(k) registry, which tracks cleared devices in the United States. These listings reflect compliance with EU classification (Class I, II, IIa, IIb) and U.S. premarket notification requirements, respectively.

Under EU Medical Device Regulations, 3A Healthcare S.r.l.’s devices are classified into Class I, Class II, Class IIa, and Class IIb. The classification determines regulatory requirements, such as risk assessment, clinical evaluation, and post-market surveillance. For example, Class IIb devices (e.g., certain nebulizers) require stricter scrutiny due to higher associated risks, while Class I items (e.g., simple accessories) have lower regulatory burdens but still must meet safety and performance standards.

The FDA’s 510(k) registry includes devices that have undergone premarket notification (510(k)) clearance in the U.S., meaning they are deemed substantially equivalent to a legally marketed predicate device. Since 3A Healthcare’s respiratory devices (e.g., nebulizers, suction accessories) are marketed in the U.S., those cleared for commercialization are listed here. This does not imply FDA approval of the company but confirms individual devices meet U.S. regulatory standards for safety and effectiveness.