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DEVICE DETAILS

NAME OF DEVICEUCARE Surgical Face Mask
ESTABLISHMENT NAMEUPA HEALTHCARE PRODUCTS SDN. BHD.
ROLE OF ESTABLISHMENTMANUFACTURER
REGISTRATION NOGA7124421-70592
BRAND NAMEUCARE
MEDICAL DEVICE CATEGORYSINGLE-USE DEVICES
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTION1. A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood,body fluids, and airborne particulate materials) during medical procedures and patient examination; it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor intended to protect the upper face/eyes from debris/fluid. This is a single-use device. 2. These masks could be used by the general public, patients and other persons to reduce the risk of spread of infections particularly in epidemic or pandemic situations.
DEVICE INTENDED PURPOSE1. A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood,body fluids, and airborne particulate materials) during medical procedures and patient examination; it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor intended to protect the upper face/eyes from debris/fluid. This is a single-use device. 2. These masks could be used by the general public, patients and other persons to reduce the risk of spread of infections particularly in epidemic or pandemic situations.
VALIDITY DATE OF REGISTRATION06/09/2021 - 05/09/2026

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Surgical / Medical Face Mask, Single-Use [UCARE Surgical Face Mask][Normal Ear Loop]9551008980166
2Surgical / Medical Face Mask, Single-Use [UCARE Surgical Face Mask][Wider Ear Loop]9551008980173
3Surgical / Medical Face Mask, Single-Use [UCARE Surgical Face Mask][Normal Ear Loop]9551008980128
4Surgical / Medical Face Mask, Single-Use [UCARE Surgical Face Mask][Wider Ear Loop]9551008980135
5Surgical / Medical Face Mask, Single-Use [UCARE Surgical Face Mask][Normal Ear Loop]9551008980210
6Surgical / Medical Face Mask, Single-Use [UCARE Surgical Face Mask][Normal Ear Loop]9551008980258
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