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12 February 2026, 14:33

Great Stone resident secures FDA approval, enters U.S. market with medical devices

Photo courtesy of industrialpark.by
Photo courtesy of industrialpark.by
MINSK, 12 February (BelTA). Asomedica Co.Ltd, a resident company of the Great Stone Industrial Park, has obtained certification from the U.S. Food and Drug Administration (FDA), the first in the history of Belarus’ medical industry, and has started supplying its products to the U.S. market, the park’s press service told BelTA. 
The company is now the only medical enterprise in the Republic of Belarus to have successfully completed the FDA certification process. The first shipment to the USA has already been made.

FDA certification confirms that the company’s production processes and medical devices meet strict international standards for safety, quality, and traceability. This status opens up the USA market for official sales and significantly expands the company’s export reach to include Canada, the Middle East, Asia, Latin America, and Africa.

The FDA certificate covers 33 product groups of disposable medical devices manufactured by the company.

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