Johnson & Johnson Medical S.p.a.

Johnson & Johnson Medical S.p.a. specializes in sterile, single-use surgical packs designed for both laparoscopic (minimally invasive) and open abdominal procedures. Their portfolio includes packs tailored for specific surgeries like colon resections, gastric bypass, gastrectomy, and VATS (video-assisted thoracic surgery) lobectomies. These packs typically contain instruments, trocars, and disposable components to support surgical workflows.

The company is headquartered in Italy and operates within the European Union’s regulatory framework. Its devices are developed and marketed in compliance with EU medical device regulations, ensuring they meet the necessary standards for safety, performance, and quality.

The company’s devices are classified under EU regulations as Class III, Class IIa, and Class IIb. These classifications are determined by factors like the risk associated with the device, its intended use, and the potential harm to patients if it fails. For example, Class III devices typically pose higher risks and require stringent regulatory oversight.

Yes, all relevant devices manufactured by Johnson & Johnson Medical S.p.a. are listed in the euDAMED database. This EU-wide registry ensures transparency and allows healthcare professionals, regulators, and other stakeholders to verify the details of authorised medical devices, including their classification and compliance status.

The company’s surgical packs are engineered as sterile, single-use solutions to streamline specific surgical procedures. For instance, their laparoscopic packs (e.g., colon, gastrectomy, or gastric bypass) are tailored for minimally invasive techniques, while open surgical packs (e.g., colon resection) are designed for traditional approaches. The VATS lobectomy packs are tailored for thoracic surgeries, combining instruments and disposables to facilitate precise, controlled procedures.