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Nureca Limited's Manufacturing Subsidiary Secures US FDA Registration



Posted On : 2025-04-12 22:34:30( TIMEZONE : IST )

Nureca Limited's Manufacturing Subsidiary Secures US FDA Registration

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 asuite of medical devices to the United States-reinforcing 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 alse 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 1SO 13485:2016 by Intertek, underscoring Nureca's adherence to global quality management and medical device manufacturing standards.

Mr. 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.

Shares of Nureca Limited was last trading in BSE at Rs. 213.85 as compared to the previous close of Rs. 208.70. The total number of shares traded during the day was 660 in over 29 trades.

The stock hit an intraday high of Rs. 215.25 and intraday low of 213.00. The net turnover during the day was Rs. 141556.00.

Source : Equity Bulls

Keywords

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