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 DEVICEPARAGON FACE MASK
ESTABLISHMENT NAMEPARAGON MEDICARE SUPPLIES SDN. BHD.
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGA4230820-48792
BRAND NAMEPARAGON
MEDICAL DEVICE CATEGORYSINGLE-USE DEVICES
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONA single-use and non-sterile medical device made of non-woven fabric. It consists of a mask body, a nose clip and earloops or with ties. The mask body is composed of an inner and outer layer of spunbond non-woven fabric and the middle layer of melt-blown non-woven fabric, with a total of 3 layers.
DEVICE INTENDED PURPOSEIt is a device used to cover the mouth and nose. It serves as a barrier for contaminants being released from the mouth of a sick person and spread to the environment or to be inhaled by people in the public. It is used also in surgery, medical and dental examination, industrial sites, general cleaning or preparation of food or worn when airborne diseases caused an outbreak.
VALIDITY DATE OF REGISTRATION02/11/2020 - 01/11/2025

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Face MaskAdult
2Face MaskAdult
3Face MaskChild
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