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 DEVICEKF94 RESPIRATOR AND MEDICAL MASK
ESTABLISHMENT NAMEPRIMO CARE
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGA10850521-75406
BRAND NAMEHEAL MADE
MEDICAL DEVICE CATEGORYSINGLE-USE DEVICES
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONcomes with 4 layer structured with high quality MB filter and comfortable breathing, elastic and lightweight earloops, and have nose clip for anti-fog
DEVICE INTENDED PURPOSEto provide the wearer with protection against the inhalation of hazardous atmospheres and very efficient for the filtration of airborne particles. it is also protect the wearer's face from contact with blood and other contaminated fluids they may be worn by medical staff, patients and others to reduce the risk of spreading infections.
VALIDITY DATE OF REGISTRATION08/10/2021 - 07/10/2026

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1KF94 RESPIRATOR AND MEDICAL MASKHMMKF94L
2KF94 RESPIRATOR AND MEDICAL MASKHMMKF94M
3KF94 RESPIRATOR AND MEDICAL MASKHMMKF94S
4KF94 RESPIRATOR AND MEDICAL MASKHMMKF94XS