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 DEVICEKN 95 FACE MASK
ESTABLISHMENT NAMEGSH PRECISION TECHNOLOGY SDN BHD
REGISTRATION NOGA8786121-76250
BRAND NAMEKN95
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONCOMES WITH EXTERNAL LAYER POLYPROPYLENE MATERIAL WATER REPELLENT LAYER AND INTERNAL LAYER NON WOVEN AND EP FABRIC MATERIAL
DEVICE INTENDED PURPOSEGSH-KN95 Medical 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 medical personnel are dressed with them in operation so that the blood, body fluid and exudation of patients, which has potential infection, can be obstructed effectively to prevent the bacteria infection. All parts of the products and processing materials are used to meet the requirements of medical materials, convenient use, safety, etc.
VALIDITY DATE OF REGISTRATION18/10/2021 - 17/10/2026

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1KN95/FFP2 Medical Face MaskGSH KN95/FFP2 FM 001
2KN95/FFP2 Medical Face MaskGSH KN95/FFP2 FM 002
3KN95/FFP2 Medical Face MaskGSH KN95/FFP2 FM 003
4KN95/FFP2 Medical Face MaskGSH KN95/FFP2 FM 004
5KN95/FFP2 Medical Face MaskGSH KN95/FFP2 FM 005
6KN95/FFP2 Medical Face MaskGSH KN95/FFP2 FM 006
7KN95/FFP2 Medical Face MaskGSH KN95/FFP2 FM 007
8KN95/FFP2 Medical Face MaskGSH KN95/FFP2 FM 008
9KN95/FFP2 Medical Face MaskGSH KN95/FFP2 FM 009
10KN95/FFP2 Medical Face MaskGSH KN95/FFP2 FM 010
11KN95/FFP2 Medical Face MaskGSH KN95/FFP2 FM 011
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