NewsVoir
Mumbai (Maharashtra) [India], April 12: Nureca Technologies Private Limited, the manufacturing subsidiary of Nureca Limited, has successfully completed its annual registration with the United States Food and Drug Administration (US FDA). The company's manufacturing facility in Mohali, Punjab is now officially listed under Registration Number: 3036779619.
This registration authorizes Nureca Technologies to continue manufacturing and exporting a suite of medical devices to the United Statesreinforcing the company's commitment to quality, regulatory compliance, and global expansion.
The following products have been listed with the US FDA:
- Pad, Heating, Powered - Dr Trust
- Bed, Flotation Therapy, Powered - Dr Trust
- Stethoscope, Manual - Dr Trust
- Massager, Therapeutic, Electric - Dr Physio; Dr Trust
- Pump, Breast, Non-Powered - Dr Trust; Trumom
These medical devices are 510(k) exempt, classified as low-to-moderate risk by the FDA, and comply with all applicable quality system regulations and labeling requirements for the U.S. market.
In addition to these listed products, the Mohali facility also manufactures a diverse portfolio of consumer-focused healthcare devices, including blood pressure monitors, nebulizers, electric massagers, oral and infrared thermometers, heating pads, orthopedic cushions and pillows, breast pumps, footcare products, and vaporizers. The facility is already approved by the Central Drugs Standard Control Organisation (CDSCO) and is certified for ISO 9001:2015 and ISO 13485:2016 by Intertek, underscoring Nureca's adherence to global quality management and medical device manufacturing standards.
Saurabh Goyal, Chairman and Managing Director of Nureca Limited, commented, "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 plays a pivotal role in the design and manufacturing of smart, accessible, and consumer-focused devices under Nureca's flagship brands - Dr Trust, Dr Physio, and Trumom.
Nureca Limited is a leading home healthcare and wellness company with a digital-first approach. Through its innovative product lines, Nureca empowers individuals to take charge of their health with clinically validated, easy-to-use devices that support preventive care and wellness.
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