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 DEVICEFACE MASK
ESTABLISHMENT NAMEONE GOLD TRADING
REGISTRATION NOGA8463021-53107
BRAND NAMEI-TEC
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONFace 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 PURPOSEFace 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.
VALIDITY DATE OF REGISTRATION22/01/2021 - 21/01/2026

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1DISPOSABLE FACE MASKITM-D08
2MEDICAL FACE MASKITM-M05
3MEDICAL KIDS MASKITM-K09
4SURGICAL MASKITM-S03
5SURGICAL MASKITM-S09
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