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 DEVICEKN95 MEDICAL FACE MASK
ESTABLISHMENT NAMEONEWORLD CORPORATE (M) SDN. BHD.
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGA7339621-75836
BRAND NAMESURGIPLUS
MEDICAL DEVICE CATEGORYSINGLE-USE DEVICES
DEVICE GROUPING TYPESINGLE
DEVICE DESCRIPTIONKN95 Medical face mask is to be use by healthcare professional during procedures to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. - BFE >95% FFP2 5 -layers surgical & protective mask - Barrier layer: Non-woven fabric blocking large particles - Filtration layer:Melt-blown layer adsorb small particles - Filtration layer: Electrostatic capture of PM0.3 particles
DEVICE INTENDED PURPOSEThis KN95 Medical Face Mask effectively filters to serve as barrier to potential air pollutants that can be harmful to patient /surgeon and healthcare personnel. The face mask’s filtration efficiency of 5 layers is intended to prevent air pollutants like allergens, virus, bacteria, dust, droplets and other harmful non-oil based particles in the air. The Face mask is Suitable to be used in Surgical Room , Medical Clinic and Hospitals
VALIDITY DATE OF REGISTRATION13/10/2021 - 12/10/2026

LIST OF DEVICE

NONAME OF DEVICEDEVICE IDENTIFIER
1KN95 MEDICAL FACE MASKKN95 Mask (5ply)
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