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.


DEVICE DETAILS

NAME OF DEVICEKN100/FFP3 SURGICAL FACE MASK
ESTABLISHMENT NAMEGSH PRECISION TECHNOLOGY SDN BHD
REGISTRATION NOGA1140421-78574
BRAND NAMEGSH
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTION5-ply medical grade respirator that offer filtration-efficient, fluid-resistant, superior comfort and breathability to help reduce wearer to exposure of potential bacteria, infection particles, blood and body fluids
DEVICE INTENDED PURPOSEGSH-KN100 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 medical personnel are dressed with them in operation so that the blood, body fluid and exudation of patientsm which has poetntial 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 material, cenvenient use, safety, etc.
VALIDITY DATE OF REGISTRATION21/11/2021 - 20/11/2026

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1GSH KN100/ FFP3 Medical Face MaskGSH KN100/FFP3 FM 001
2GSH KN100/ FFP3 Medical Face MaskGSH KN100/FFP3 FM 002
3GSH KN100/ FFP3 Medical Face MaskGSH KN100/FFP3 FM 003
4GSH KN100/ FFP3 Medical Face MaskGSH KN100/FFP3 FM 004
5GSH KN100/ FFP3 Medical Face MaskGSH KN100/FFP3 FM 005
6GSH KN100/ FFP3 Medical Face MaskGSH KN100/FFP3 FM 006
7GSH KN100/ FFP3 Medical Face MaskGSH KN100/FFP3 FM 007
8GSH KN100/ FFP3 Medical Face MaskGSH KN100/FFP3 FM 008
9GSH KN100/ FFP3 Medical Face MaskGSH KN100/FFP3 FM 009
10GSH KN100/ FFP3 Medical Face MaskGSH KN100/FFP3 FM 010
11GSH KN100/ FFP3 Medical Face MaskGSH KN100/FFP3 FM 011