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 DEVICEKN95 FFP2 Medical Mask
ESTABLISHMENT NAMEONE GOLD TRADING
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGA2174121-65254
BRAND NAMEI-TEC
MEDICAL DEVICE CATEGORYSINGLE-USE DEVICES
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONMedical 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, no pyrogen, convenient use, safety, etc.
DEVICE INTENDED PURPOSEMedical 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, no pyrogen, convenient use, safety, etc.
VALIDITY DATE OF REGISTRATION28/06/2021 - 27/06/2026

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1KN95 FFP2 Medical MaskITM-KN08-0635
2KN95 FFP2 Medical MaskITM-KN08-0636
3KN95 FFP2 Medical MaskITM-KN08-0637
4KN95 FFP2 Medical MaskITM-KN08-0638
5KN95 FFP2 Medical MaskITM-KN08-0639