Nureca Technologies Private Limited, the manufacturing arm of Nureca Limited, has completed its annual registration with the United States Food and Drug Administration (US FDA). The company’s facility in Mohali, Punjab is authorized to manufacture and export designated medical devices to the United States.
The US FDA registration covers several devices produced at the Mohali plant, including powered heating pads, powered flotation therapy beds, manual stethoscopes, electric therapeutic massagers, and non-powered breast pumps. These products, marketed under the brands Dr Trust, Dr Physio, and Trumom, are 510(k) exempt, categorized as low-to-moderate risk, and are required to meet U.S. quality system regulations and labeling standards.
Apart from the listed devices, the facility manufactures a broader range of healthcare equipment such as blood pressure monitors, nebulizers, oral and infrared thermometers, orthopedic cushions and pillows, footcare products, and vaporizers. The manufacturing site is certified under ISO 9001:2015 and ISO 13485:2016 standards by Intertek and is approved by the Central Drugs Standard Control Organisation (CDSCO).
Commenting on the registration, Saurabh Goyal, Chairman and Managing Director of Nureca Limited, stated, “Securing FDA registration is a significant milestone in our global journey. It reinforces Nureca’s core mission to manufacture trusted, innovative, and regulation-compliant healthcare products for consumers around the world.”
Nureca Technologies focuses on the development and production of medical devices aligned with the company’s portfolio of consumer healthcare brands.