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 DEVICEKF94 FFP2 RESPIRATOR AND SURGICAL MASK
ESTABLISHMENT NAMEPRIMO CARE
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGA4197121-68958
BRAND NAMEWIICARE
MEDICAL DEVICE CATEGORYSINGLE-USE DEVICES
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONKF94 FFP2 Respirator and Surgical Mask to be used by healthcare professional during procedures to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material.
DEVICE INTENDED PURPOSEto protect wearer against splashes of potentially contaminated liquids. it also intended to be used inside the operating/surgical room to protect the wearer (surgeon/patients) against risky infections diseases
VALIDITY DATE OF REGISTRATION14/08/2021 - 13/08/2026

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1KF94 FFP2 MEDICAL FACE MASK PARTICULATE RESPIRATOR AND SURGICAL MASKKF94LB
2KF94 FFP2 MEDICAL FACE MASK PARTICULATE RESPIRATOR AND SURGICAL MASKKF94LWS
3KF94 FFP2 MEDICAL FACE MASK PARTICULATE RESPIRATOR AND SURGICAL MASKKF94LW
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