General Medical Italia Ltd has achieved the following certifications, ensuring compliance and safety for all its medical devices.
Certifications Table
| Certification | Description | Link |
|---|---|---|
| ISO 13485 | ISO 13485 is an international standard that outlines the requirements for a Quality Management System in the medical device industry. This standard is specific to medical devices and covers the entire life cycle of a device, from design and development to production, installation, and servicing. | View Certificate |
| EU MDR | EU MDR stands for European Union Medical Device Regulation. It governs the safety and performance requirements of medical devices in the European market, ensuring the highest level of patient safety and providing greater transparency and traceability of medical devices throughout their lifecycles. | View Certificate |
| Certified Product Families | General Medical Italia Ltd has certified the following product families, all compliant with the new medical device regulation (MDR 2017/745): Lucerna RF-TILT (Series), Lucerna U-Arm (Series), Genève 40 M (Series). | View Certificate |
| EUDAMED Registration | EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices, serving as a central hub for information related to medical devices within the European Union. | View Registration |
ISO 13485
ISO 13485 is an international standard that outlines the requirements for a Quality Management System in the medical device industry. This standard is specific to medical devices and covers the entire life cycle of a device, from design and development to production, installation, and servicing.
View CertificateEU MDR
EU MDR stands for European Union Medical Device Regulation. It governs the safety and performance requirements of medical devices in the European market, ensuring the highest level of patient safety and providing greater transparency and traceability of medical devices throughout their lifecycles.
View CertificateCertified Product Families
General Medical Italia Ltd has certified the following product families, all compliant with the new medical device regulation (MDR 2017/745): Lucerna RF-TILT (Series), Lucerna U-Arm (Series), Genève 40 M (Series).
View CertificateEUDAMED Registration
EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices, serving as a central hub for information related to medical devices within the European Union.
View Registration
