All of our products are CE marked for European sales and manufactured under EN ISO 13485:2003 certification. The Biomerica main campus occupies an area of over 23,000 square feet in Irvine, California. This complex houses the company's headquarters, including administrative offices, laboratories, and FDA registered manufacturing facilities. Biomerica, Inc. also operates a 10,000 square foot production facility in Mexicali, Mexico. Like the US headquarters, the Mexico facility is both EN ISO 13485 and FDA certified.