FDA-20192089UYASA? Republic of the Philippines FOOD AND DRUG ADMINISTRATION ==" ~sytrisrrtee Civie Drive, Filinvest Corporate City, Alabang, Muntinlupa City Registration Status INITIAL FDA Registration No. : MDR=09046 Classification CERTIFICATE OF PRODUCT REGISTRATION Pursuant to the provisions of Republic Act (R.A.) No. 3720 as amended, known as the Foods, Drugs. Device and Cosmetics Act, the product described hereunder has been found to conform with the requirements and. standards for registration of medical devices per existing regulations in forve as of date hereot. Name of Product RAYNER SULCOFLEX® TRIFOCAL INTRAOCULAR LENS Size/Code; 1OL703F, -3.0D to +3.0D (increments 0.5D), 1.0D to +1.0D (increments 0.25D) Trifocal, diffractive, +3.5 D near add and +1.7SD Intermediate add at the IOL plane Manufacturer Rayner Intraocular Lenses Limited - West Sussex, United Kingdom ‘Trader Importer + Clinieal Global Frontiers, ine - Pulo, San Rafuel, Bulacan Distributor + Clinical Global Frontiers, Inc. - Pulo, San Rafsel, Bulacan Approved Use + Intended to be used for the removal of the cataractous crystalline lens of the eye, an IOL is placed into the eye to provide refractive correction, restoring sight Claimed SheltLite : S years This registration shall be valid for one year(8) and shall expire on 06 December 2020 subject to the conditions listed on the reverse side. No change in the information, labelling and commercial presentation of this product shall be made during the effectivity of this registration without approval of this Office. ‘This registration is subject to suspension, cancellation or recall should violation of any provisions of R.A. 3720, as amended, and/or regulations issued thereunder involving the product be committed. Witness My Hand and Seal of this Office, this 6th day of December, 2019. BY AUTHORITY OF THE DIRECTOR GENERAL wh ENGR. BAYANIC/AAN JUAN, MSc, MNSA, CESE Director IV DIN 0190123092127 OR.No 11062251 Amount P 1,515.00 Datelssued £17 January 2019 (ENT FDA-0464289