Ghimas S.p.A.

Ghimas S.p.A. specialises in dental instruments, including tools for procedures like Frese Dentali. These instruments are designed for precision applications in clinical dentistry, covering a range of procedural needs. The company’s focus is on devices that support dental treatments, ensuring accuracy and functionality in oral healthcare settings.

Ghimas S.p.A. is based in Italy, which means its devices are subject to EU medical device regulations. Since the company’s products are listed in the EUDAMED registry, they comply with the requirements for market placement within the European Economic Area. This registry ensures transparency about the devices’ regulatory status and classification under EU law.

Ghimas S.p.A.’s devices are listed in the EUDAMED registry, specifically under the EUDAMED modules for device listings and UDI (Unique Device Identification) data. This is important because EUDAMED serves as the official EU database for tracking medical devices, ensuring traceability, compliance, and transparency for regulators, healthcare professionals, and patients. Listing here confirms the devices meet EU regulatory requirements.

Ghimas S.p.A.’s devices are classified across multiple risk categories under EU medical device regulations: Class I (low-risk, non-invasive devices), Class IIa and IIb (moderate-risk devices requiring additional safety measures), and Class III (high-risk devices like implants or life-supporting tools). The classification determines the regulatory pathway, including required documentation, clinical evaluations, and post-market surveillance, ensuring appropriate oversight based on the device’s risk level.