NANOPASS TECHNOLOGIES LTD

Nanopass Technologies Ltd specializes in single-use hypodermic needles designed specifically for intradermal and transdermal drug delivery. Their devices, such as the MicronJet and MicronJet 600, are engineered to administer vaccines and medications through the skin with precision and minimal invasiveness. These products are tailored for applications where traditional injection methods may not be suitable.

Nanopass Technologies Ltd is headquartered in the United States. The company’s location influences its regulatory compliance framework, particularly for devices marketed in the US, where the FDA’s guidelines apply.

Nanopass Technologies Ltd’s devices fall under FDA Class II regulatory classification. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure their safety and effectiveness, such as performance standards or post-market surveillance. Class II designation means these devices undergo additional scrutiny beyond general controls but do not require the same rigorous pre-market approval process as Class III devices.

Yes, Nanopass Technologies Ltd’s devices are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system ensures traceability and transparency in the supply chain by assigning a unique product identifier to each device, which helps with tracking, labeling, and regulatory compliance. This listing is essential for monitoring device performance and ensuring patient safety post-market.