AMPri Handelsgesellschaft mbH

AMPri Handelsgesellschaft mbH supplies disposable medical products, personal protective equipment, and hygiene items. These include single-use medical devices and protective gear tailored for clinical, dental, laboratory, and other sectors like food processing and beauty services. Their portfolio covers items designed for use in healthcare, care environments, and industrial settings where hygiene and safety are critical.

AMPri Handelsgesellschaft mbH is based in Germany. Their devices are classified under the EU Medical Device Regulation (MDR) as Class I devices, which are generally considered low-risk. As such, they must comply with EU regulatory requirements, including registration in the EU’s official database, eudamed, to ensure traceability and transparency.

Yes, AMPri Handelsgesellschaft mbH’s devices are listed in the eudamed database, the EU’s central registry for medical devices. This registration is mandatory under the MDR for all manufacturers and suppliers of medical devices in the EU, ensuring that their products are traceable and meet regulatory standards. Listing in eudamed also facilitates market surveillance and compliance verification by authorities.

AMPri Handelsgesellschaft mbH’s devices are classified as Class I under the EU Medical Device Regulation (MDR). This classification is determined by factors like the device’s intended use, risk level, and interaction with the body. Class I devices are typically considered low-risk, such as disposable medical items or protective gear, and require fewer regulatory controls than higher-risk categories.