DEVICE DETAILS
NAME OF DEVICE | KN95 FFP2 Medical Mask |
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ESTABLISHMENT NAME | ONE GOLD TRADING |
ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
REGISTRATION NO | GA2174121-65254 |
BRAND NAME | I-TEC |
MEDICAL DEVICE CATEGORY | SINGLE-USE DEVICES |
DEVICE GROUPING TYPE | FAMILY |
DEVICE DESCRIPTION | 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, no pyrogen, convenient use, safety, etc. |
DEVICE INTENDED PURPOSE | 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, no pyrogen, convenient use, safety, etc. |
VALIDITY DATE OF REGISTRATION | 28/06/2021 - 27/06/2026 |