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 DEVICESurgical Face Mask
ESTABLISHMENT NAMEU CARE PROTECTION INDUSTRIES SDN BHD
REGISTRATION NOGA3523522-94730
BRAND NAMESurgical Face Mask / Daxxo
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONA single use non sterile and latex free device made of 2 layer of non woven and 1 layer of melt blown. Adjustable to fit faces of various shapes and sizes. The middle layer of face mask (Melt blown) which tested for Bacterial Filtration Efficiency that has sufficient protection against haze particles, dust and harmful droplets. It also high breathability, hypoallergenic, soft and lightweight. This device is appropriate to be use by healthcare professional during surgical procedures to protect both the patient and healthcare personnel.
DEVICE INTENDED PURPOSEA disposable single use surgical face mask is to be used as a barrier to prevent air-borne transfer of infectious, large particle droplets and various micro-organisms. It is designed to be used in hospital, clinic, operating theatre, dental, cleanroom and critical environment.
VALIDITY DATE OF REGISTRATION16/06/2022 - 15/06/2027

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1KF99+ Surgical MaskDX99101
2KF99+ Surgical MaskDX99103
3KF99+ Surgical MaskDX99104
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