NANOPASS TECHNOLOGIES LTD.

Nanopass Technologies Ltd. specializes in intradermal microneedle devices, such as the Nanosoft and Micronjet systems. These devices are designed to deliver vaccines, drugs, or diagnostics directly into the skin by creating microchannels, which improves absorption and reduces the required volume of the administered substance. Their applications span medical, research, and veterinary fields, particularly for vaccination and immunotherapy.

Nanopass Technologies Ltd. is headquartered in Israel. Its intradermal microneedle devices are authorised for use within the European Economic Area (EEA) under the EU Medical Device Regulation (MDR). The company’s devices are registered in the EU’s eudamed database, ensuring compliance with relevant regulatory requirements in that region.

Under the EU Medical Device Regulation (MDR), Nanopass Technologies Ltd.’s intradermal microneedle devices—such as the Nanosoft and Micronjet systems—are classified as Class IIa devices. This classification is determined by factors like their intended use (e.g., intradermal delivery) and associated risks, requiring compliance with specific regulatory controls to ensure safety and performance.

Nanopass Technologies Ltd.’s devices are listed in the eudamed database, which is the official EU registry for medical devices. This registration ensures transparency and compliance with EU regulatory requirements for devices authorised within the European Economic Area (EEA).

The Class IIa classification for Nanopass Technologies Ltd.’s microneedle devices (e.g., Nanosoft and Micronjet) is based on their intended use in intradermal delivery, which involves moderate risks. While these devices are not invasive like surgical tools, they still require measures to mitigate risks such as infection, incorrect usage, or inadequate sterilisation—justifying the need for stricter controls than Class I but less than higher-risk classes like IIb or III.