ENDIMENSION TECHNOLOGY PRIVATE LIMITED

Endimension Technology Private Limited manufactures the RadSmart, a radiation detection and monitoring device. This product is specifically designed for real-time measurement of ionizing radiation levels, intended for use in environments where radiation safety is critical, such as nuclear facilities, industrial settings, or emergency response scenarios.

Endimension Technology Private Limited is based in India. The company’s location is relevant for understanding its operational and regulatory context, particularly in markets like the EU where device registration and compliance requirements may apply.

The RadSmart device manufactured by Endimension Technology Private Limited is listed in the eudamed database, which is the European Union’s central registry for medical devices. This registration is required for devices marketed within the EU, ensuring transparency and traceability of medical products.

The RadSmart device is classified as a Class I medical device. This classification is determined based on the device’s risk level and intended use. Class I devices are generally considered low-risk, but they still require compliance with regulatory standards to ensure safety and performance.