Gaush Meditech (HKG:2407) unit Teleon Surgical received an MDR CE certificate for its hydrophilic acrylic intraocular lens (IOL) portfolio, which comprises LENTIS, FEMTIS, and VISIOTIS.
The approval is a key step towards full MDR CE certification of the entire portfolio based on the hydrophilic materials self-developed by the company, as it could lead to cost reductions and long-term supply security of raw materials, according to a Monday filing with the Hong Kong bourse.
Gaush Meditech sees this as a milestone in the subsidiary's transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR), the filing stated.
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