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 DEVICEProtective Face Mask for Medical Use
ESTABLISHMENT NAMEFERMETEC MEDICAL SDN BHD
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGA4266720-49430
BRAND NAMETai Da Kang
MEDICAL DEVICE CATEGORYSINGLE-USE DEVICES
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONThe product consists of mask body, nose clip and mask belt. This product consists of outer PP non-woven fabric, middle layer PP hot water cotton, filter layer PP melt spray cloth, inner layer PP non-woven fabric fours layers
DEVICE INTENDED PURPOSEThe scope of application is to applicable to the face of a person wearing contact with a virus in a material institution and is used to prevent the transmission of the virus from the patient to the medical staff. It can be used as highest protection in operating theatre for surgeons too. Suggested settings and applications: Operating Rooms, Clinics, TB Wards, Patient Care, Labour and Delivery, Infection Control Practices, frontline healthcare workers for COVID-19, Laboratory, emergency or pandemic preparedness planning, stockpiling, etc.
VALIDITY DATE OF REGISTRATION11/11/2020 - 10/11/2025

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Protective face mask for medical use-
2Protective face mask for medical use-
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