This facility is provided to enable any interested parties to search for Registered Medical Device, Registered CAB, Licensed Establishments under Section 5, 10, 15 of Medical Device Act 2012 (Act 737) respectively and Notified Medical Device under Medical Device (Exemption) Order 2016. Any party who wishes to know whether an establishment who is dealing with medical device has been licensed under Act 737 may search the establishment by inserting the establishment name or license number in the searching field below.


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DEVICE DETAILS

NAME OF DEVICEOuFinity Surgical Face Mask
ESTABLISHMENT NAMEGPI TECHNOLOGY SDN BHD
ROLE OF ESTABLISHMENTMANUFACTURER
REGISTRATION NOGA6649821-78710
BRAND NAMEOuFinity
MEDICAL DEVICE CATEGORYSINGLE-USE DEVICES
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONA flexible, loose-fitting surgical face mask designed to be placed over the mouth and/or nose of a user to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials) during medical/surgical procedures and patient examination; it is not a form-shaped filtering device (i.e., not a respirator).
DEVICE INTENDED PURPOSEThese masks could be used by the general public, patients and other persons such as doctor, hospital staff to reduce the risk of spread of infections particularly in epidemic or pandemic situations by cover user's nose and mouth that provides a physical barrier from transmission of viruses, microorganisms, and body fluids.
VALIDITY DATE OF REGISTRATION21/11/2021 - 20/11/2026

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1OuFinity Surgical Face MaskA102 Premium
2OuFinity Surgical Face MaskA103 Ultra
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