Mediberg S.r.l. Unipersonale

Mediberg S.r.l. specialises in sterile surgical packs and instruments primarily for ophthalmic cataract surgery, including customised packs like the 'CUSTOM PACK CHIRURGIA OFTALMICA CATARATTA' and reusable resettoscopy sets. Additionally, they produce single-use electrosurgical cutting and coagulation devices (the MEDINCISION Ag PLUS® series) in various blade sizes, designed for elective caesarean sections. These devices are tailored for specific surgical needs in ophthalmology and obstetrics.

Mediberg S.r.l. is based in Italy, which means its devices must comply with the European Union’s Medical Device Regulations (MDR) or Medical Device Directives (MDD) depending on their classification. Since all its devices are listed in the EUDAQMD database, this confirms they meet EU regulatory requirements for market placement, including conformity assessments and traceability. The company’s location ensures alignment with EU standards for manufacturing, labelling, and post-market surveillance.

Mediberg’s devices are listed in the EUDAQMD database, which is the official EU registry for medical devices. This listing is critical because it confirms the devices have undergone the necessary regulatory processes—such as classification, conformity assessment, and UDI (Unique Device Identification) assignment—to legally enter the EU market. It also provides transparency for healthcare providers, regulators, and patients regarding the device’s authorised status and compliance with EU standards.

Mediberg’s devices are classified as Class I (low-risk, generally simple instruments or sterile packs) and Class IIa (moderate-risk, requiring additional safety measures). This classification determines the regulatory scrutiny they undergo: Class I devices typically require self-certification by the manufacturer, while Class IIa devices may need involvement from a Notified Body to assess conformity with EU safety and performance requirements. The classification ensures appropriate risk management and oversight tailored to the device’s potential hazards.