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 DEVICEKF94 SURGICAL FACE MASK
ESTABLISHMENT NAMECONCEPT HERO SDN BHD
ROLE OF ESTABLISHMENTMANUFACTURER
REGISTRATION NOGA10788323-116280
BRAND NAMECONCEPTHERO
MEDICAL DEVICE CATEGORYSINGLE-USE DEVICES
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONSurgical masks are examples of personal protective equipment that are used to protect the wearer from particles or from liquid contaminating the face. It is important to recognize that the optimal way to prevent transmission of microorganisms, such as viruses, is to use a combination of interventions from across the hierarchy of controls.
DEVICE INTENDED PURPOSEA surgical mask is intended to be worn by health professionals during surgery and certain health care procedures to catch microorganisms shed in liquid droplets and aerosols from the wearer's mouth and nose. The effectiveness of surgical masks in reducing the risk of infection among other healthcare workers and in the community.
VALIDITY DATE OF REGISTRATION20/01/2023 - 19/01/2028

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1KF94 Disposable 3D 4ply Face Mask FM-KF94-W+-M-200
2KF94 Disposable 3D 4ply Face Mask FM-KF94-W+-M-220
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