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 PREMIUM PROTECTIVE SURGICAL FACE MASK
ESTABLISHMENT NAMEWORLDTREND ENTERPRISE
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGA3196221-80190
BRAND NAMEMEDI-CARE
MEDICAL DEVICE CATEGORYSINGLE-USE DEVICES
DEVICE GROUPING TYPESINGLE
DEVICE DESCRIPTIONDisposable surgical face masks embedded with nose clip and ear loops or with ties. This surgical face mask made of 4-ply of premium non-woven fabric with Bacterial Filtration Efficiency (BFE) >99% and Particle Filtration Efficiency (PFE) >95%. Its involved in 4-fold design for comfortable fit with strong and elastic ear loops.
DEVICE INTENDED PURPOSEIntended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and airborne particulates.
VALIDITY DATE OF REGISTRATION05/12/2021 - 04/12/2026

LIST OF DEVICE

NONAME OF DEVICEDEVICE IDENTIFIER
1KF94 PREMIUM PROTECTIVE SURGICAL FACE MASKMC-003