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Episurf Medical erhält CE-Zertifizierung für sein Knie-Implantat und bereitet baldige Produkteinführung am Markt vor
Date:7/7/2013

STOCKHOLM, July 5, 2013 /PRNewswire/ --

Episurf Medical erhielt die CE-Zertifizierung für sein personalisiertes Implantat Episealer® Femoral Condyle zur Behandlung von Knorpelschäden im Knie, Wiederherstellung der Bewegungsfähigkeit und Schmerzreduktion. Die CE-Zertifizierung ist eine Voraussetzung für den Verkauf von Medizinprodukten auf dem europäischen Markt.

     (Photo: http://photos.prnewswire.com/prnh/20130704/626331 )

Die CE-Zertifizierung wurde erteilt, nachdem die Episealer® Femoral Condyle und ihre technische Dokumentation einer Bewertung durch Regulierungsbehörden unterzogen worden war und erfolgreich nachgewiesen wurde, dass sie die EU-Normen für medizinische Geräte erfüllt. Die CE-Zertifizierung bedeutet, dass Episurf Medical die formale Zulassung hat, die erforderlich ist, um das Produkt in der EU zu vermarkten und verkaufen.

"Die Zulassung ist ein wichtiger Meilenstein für das Unternehmen. Sie ermöglicht es uns, Produkte in Europa auf den Markt zu bringen und für Episurf Medical die erste Phase der Vermarktung einzuleiten. In Kombination mit der kürzlichen Bezugsrechtsemission im Wert von 70 Millionen SEK und unterzeichneten Vertriebsverträgen in der Schweiz und in Polen verleiht uns diese neue Zulassung eine starke Position bei der Markteinführung unseres Produkts in diesem Herbst", so Nina Bake, CEO von Episurf Medical.

Episealer® Femoral Condyle wird zunächst auf dem europäischen Markt eingeführt. Um eine hohe Qualität zu gewährleisten und Patienten wie auch Chirurgen maximale Sicherheit zu bieten, wird die Markteinführung phasenweise und unter kontrollierten Beding
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SOURCE Episurf Medical
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