Document 5b380gQeRZV958q4yddpBoemN

pharmpur Pharmpur GmbH Messerschmittring 33 86343 Knigsbrunn Comment to PFAS Restriction Proposal Consultation - Pharmpur GmbH, Germany Commentator: Pharmpur GmbH Messerschmittring 33, 86343 Knigsbrunn www.pharmpur.de www.ophthafutur.de Contact Person: Dr. Andreas Hofmann Head of Regulatory Affairs, PRRC (MDR Art. 15) 1 (eharmpur.de Purpose Request listing of Perflunafen, Perfluorooctane, Hexafluoroethan and Octafluoropropan in the subuse implantable medical devices Description of the Products Marketed The above mentioned materials are used as key component for the manufacture of products, which are substantial implantable Medical Devices, i.e., ocular endotamponades acc. to ISO 16672 and are used in retinal surgery. Each of our products consists of 100% of one the ultra-purified (inhouse process) substances mentioned above. These substances are active substances within the definition of medical devices, i.e., they are acting physically acc. to their special chemical/physical properties. Pharmpur as a legal manufacturer as well as contract manufacturer has a market share within the EEA market of of more than 200/0 for eye surgery products for vitreoretinal surgery and is marketing its products world-wide. 0ur Proposal for Reclassification of the Derogation of these Substances for Use as Ophthalmic Endotamponades (Medical Devices) Pharmpur GmbH Messerschmittring 33 86343 Knigsbrunn Tel.: +49 8231 9577-0 Fax: +49 8231 9577-22 E-mail: info@pharmpur.de Geschftsfhrer: Dr. Dirk-Henning Menz Sitz Knigsbrunn Amtsgericht Augsburg HRB 12626 USt-IdNr.: DE 127494472 Bankverbindungen: HypoVereinsbank IBAN: DE71 7202 0070 0002 2392 48 BIC: HYVEDEMM408 Kreissparkasse Augsburg IBAN: DE91 7205 0101 0030 1750 53 BIC: BYLADEM1AUG ......... `,. Aa