Pomona, California, May 17, 2005 -- Amsino International, Inc., a California-based manufacturer of disposable medical devices, announced today that TUV (SUD) Product Service, one of the world's largest certification group and notified body in medical device industry, has awarded Amsino International, Inc. ISO 9001:2000 certification, ISO13485:2003 certification, and CE certification on May 10, 2005. This certification reconfirms Amsino's commitment to quality and product safety. The certification scope covers "design and development, production, and distribution" processes related to medical devices. After the CE certification, Amsino can put CE mark and sell the medical devices on EU market under Amsino's own name (as the manufacturer), instead of using customer's name and brand in the past as an OEM or private label manufacturer. ISO 9001:2000 is the third edition of the international quality standard originally issued in 1987 by the International Standards Organization (ISO). With the certification, Amsino has demonstrated that its business processes are designed to deliver continuous improvement and customer satisfaction.

ISO13485:2003 is the international quality management standard for designers and manufacturers of medical devices. Based on ISO9001:2000, ISO13485:2003 has more provisions on regulatory requirements of medical device. With the certification of ISO13485, Amsino has demonstrated that it has established the mechanism of consistently meeting the ever-changing regulations of medical device. Amsino has actively pursued this certification as part of the company's ongoing commitment to patient well-being, product safety and regulatory compliance.

CE certification is the mandatory requirements of selling medical devices on European Union market, which includes 25 member countries after the year 2004. In the certification scope, Amsino has 20 devices, which covers over 90% of Amsino's products. With the growth of the business, CE certification scope would be extended as necessary.

Commenting on the certification, Dr. Richard Lee, President of the Amsino International, Inc. said, "We are very excited about the ISO/CE certifications. We can now service our customers in Europe!"

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For additional information, please contact Ms. Melinda McNiel - Director, Quality Assurance at at melinda_mcniel@amsino.com.

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