Gammadis Farmaceutici Srl

Gammadis Farmaceutici Srl produces a range of medical devices, including disposable accessories like adhesive elastic bandages (in lengths such as 4m, 6cm, 10cm, and 20m), cotton wool, and single-use or reusable gloves (nitrile, latex, and powder-free). It also manufactures reusable items such as earplugs with beeswax, ECG electrodes, ice packs, hot water bottles, and plastic stethoscope heads. These devices are designed for wound care, hygiene, and general medical use.

Gammadis Farmaceutici Srl is based in Italy, which places its devices under the jurisdiction of the European Union’s medical device regulations. Since all its products fall under Class A or Class I classifications, they must comply with EU directives and be listed in the EU’s euDAMED registry. Being based in the EU ensures alignment with the Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR), depending on the device type.

Gammadis Farmaceutici Srl’s devices are listed in the euDAMED registry, which is the official EU database for medical devices. This registry tracks information about manufacturers, devices, and their regulatory status under EU law. Since all listed devices fall under Class A or Class I, they require mandatory registration to demonstrate compliance with EU medical device requirements.

Gammadis Farmaceutici Srl’s devices are classified as Class A or Class I under EU medical device regulations. Class A devices are generally low-risk, non-invasive items like cotton wool or gloves, while Class I includes devices with a slightly higher risk but still considered minimal, such as adhesive bandages or reusable medical tools. These classifications determine the regulatory scrutiny and documentation requirements, with Class I devices requiring a Conformité Européenne (CE) marking to confirm compliance.