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 DEVICEFRONTIFIE KF94 FACE RESPIRATOR
ESTABLISHMENT NAMENEUTROVIS SDN BHD
ROLE OF ESTABLISHMENTMANUFACTURER
REGISTRATION NOGA5775223-128738
BRAND NAMEFRONTIFIE
MEDICAL DEVICE CATEGORYSINGLE-USE DEVICES
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONFrontifie KF94 Face Respirator is designed to limit unfiltered air entry with the flaps staying flush against your face and provides a secure seal and double protection from all sides of the face mask. The 2 layers of inner melt-blown fabric and its innovative 3D design allow for more space between your mouth and the face mask and reduced the risk of the wearer readjusting their face mask
DEVICE INTENDED PURPOSEFrontifie KF94 Face Respirator with BFE >=98% and PFE >= 98% is 4-Ply Disposable Medical Face mask is to be use as a barrier to prevent air-borne transfer of bacteria and particles. It is designed to be use in hospital, clinic, operating theater and clean room environment , etc
VALIDITY DATE OF REGISTRATION18/04/2023 - 17/04/2028

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Frontifie KF94 Face Respirator - BlackFTF005
2Frontifie KF94 Face Respirator - WhiteFTF006
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