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Implant products receive full EU Class III medical device certification.
2004 APR 1 - (NewsRx.com & NewsRx.net) -- Mentor Corp. (MNT), a supplier of medical products, has been notified that the company's breast implant products have received full European Union Class III CE Mark approval and recertification.
This certification of safety and effectiveness covers all of the breast implant products currently marketed and distributed by Mentor in the European Union including saline and silicone gel-filled breast implants, and the company's Becker implants for single-stage breast reconstruction. Products manufactured in Mentor's manufacturing facilities in Irving, Texas and in Leiden, the Netherlands, were both reviewed and certified.
"This Class III certification is the most rigorous level of review and approval by the European regulatory authorities and provides further evidence of the safety ...
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