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Fluoron GmbH

Ultra pure biomaterials for ophthalmology

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Fluoron GmbH, a sister company of Geuder AG, develops and produces ultrapure innovative biomaterials for retinal surgery. In addition to unique silicone oil and gas tamponades that remain in the eye for a longer period, Fluoron also produces perfluorocarbons and semi-fluorinated alkanes for intra-operative use. The portfolio is expanded through dyes for specific staining of intraocular tissues, such as Brilliant Peel Dual Dye.

For more information, please visit our product page or the corporate website www.fluoron.de.

Wechsel der benannten Stelle

Fluoron GmbH is changing its Notified Body from BSI Group Germany to BSI Group UK (identification number 0086), because BSI is consolidating their certification activities for medical device manufacturers under the global Notified Body BSI Group UK, closing down Notified Body BSI Group Germany.The identification number of our previous Notified Body CE 0535 remains valid for the products we have hitherto first placed on the market, until their shelf life has expired. The transition period for change of documents, printing materials, packaging materials and affected products will last until end of December 2016.

System certificate

ISO 13485:2003 & EN ISO 13485:2012