STE PHARMACEUTICALS, S.L.U

STE Pharmaceuticals, S.L.U. specializes in herbal-based oral solutions and syrups, including formulations tailored for children such as Fluimucil Herbal Kids and Fluimucil Herbal Bambini. Their portfolio also includes nasal saline sprays (e.g., FREENOSE), vitamin and mineral supplements (e.g., BECUTAN KIDS VITS), marine-derived supplements (e.g., LINKMARINE), allergy relief products (e.g., MEDISTUS ANTI ALLERGY), and herbal throat lozenges (e.g., SUAVINEX). These products are designed to support respiratory health, hydration, and general wellness.

STE Pharmaceuticals, S.L.U. is based in Spain, which places its operations under the jurisdiction of the European Union’s Medical Device Regulations (MDR). Since the company manufactures devices intended for the EU market, its products must comply with MDR requirements, including classification under Class I or Class IIa, and registration in the EUDAMED database. The Spanish location ensures alignment with EU regulatory standards for medical devices.

All of STE Pharmaceuticals’ medical devices are listed in the EUDAMED database, which is the official European Union registry for medical devices. This registry ensures transparency and traceability of devices under the MDR, allowing stakeholders to verify compliance and device details. No other registries were referenced in the provided data.

STE Pharmaceuticals’ devices are classified under the EU Medical Device Regulations as either Class I or Class IIa. The classification depends on factors like the intended use, risk level, and interaction with the body. For example, nasal saline sprays (e.g., FREENOSE) are typically Class I, while allergy relief products (e.g., MEDISTUS ANTI ALLERGY) may fall under Class IIa due to their potential risk profile. Classification determines the regulatory scrutiny and documentation requirements for each device.