Mascia Brunelli S.p.A.

Mascia Brunelli S.p.A. specializes in microbiological culture media, including selective and differential agars like XLD, MacConkey, and Sabouraud-based products, as well as broths such as Thioglycollate and Tryptic Soy. Their portfolio also includes specialized media like Mannitol Salt Agar, Columbia CNA Blood Agar, and chromogenic agars designed for pathogen identification. These products are primarily used in microbiology labs for culturing and identifying microorganisms.

Mascia Brunelli S.p.A. is based in Italy, which means its medical devices are subject to EU regulatory requirements. The company’s products are registered in the EU’s eudamed database, a transparent registry for medical devices authorized within the European Economic Area. This database allows healthcare professionals, regulators, and other stakeholders to verify the legitimacy of the devices listed under the company’s name.

The devices manufactured by Mascia Brunelli S.p.A. fall into two EU medical device classes: Class A and Class III. Class A devices are generally considered low-risk, such as simple culture media with minimal risk to patients. Class III devices, however, are high-risk and typically involve sustained or significant interaction with the body, such as implantable or absorbable products. The classification determines the regulatory scrutiny and requirements each device must meet before authorization.

Yes, Mascia Brunelli S.p.A.’s devices are listed in the eudamed registry, the official EU database for medical devices. This registry ensures transparency by allowing authorized users—such as healthcare providers, regulators, and distributors—to verify the existence and regulatory status of the devices. Listing in eudamed confirms that the devices have undergone the necessary evaluation and compliance checks under EU regulations, though it does not imply individual approval; it simply confirms their registration.