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 DEVICE	KF94 Medical Face Mask
ESTABLISHMENT NAME	ZERO DEGREE HEALTHCARE SDN BHD
ROLE OF ESTABLISHMENT	AUTHORIZED REPRESENTATIVE
REGISTRATION NO	GA5573722-90517
BRAND NAME	MediShield
MEDICAL DEVICE CATEGORY	SINGLE-USE DEVICES
DEVICE GROUPING TYPE	FAMILY
DEVICE DESCRIPTION	KF94 Medical Face Mask has 4 protective layers with a 3D fit Airy-technology to fit different face shapes. The outer layer protects from the virus while the innermost layer is made of soft material to prevent chafing.
DEVICE INTENDED PURPOSE	KF94 Medical Face Mask is intended for clinical staff to wear during non-invasive operation. It covers the mouth, nose and mandible of the user, providing a certain physical barrier to prevent the direct penetration of pathogens, microorganisms, particles, etc.
VALIDITY DATE OF REGISTRATION	18/04/2022 - 17/04/2027

LIST OF DEVICE

NO	NAME OF DEVICE	IDENTIFIER
1	KF94 Medical Face Mask	MKF94DG-001
2	KF94 Medical Face Mask	MKF94DB-002
3	KF94 Medical Face Mask	MKF94WR-003
4	KF94 Medical Face Mask	MKF94B-004
5	KF94 Medical Face Mask	MKF94OG-005
6	KF94 Medical Face Mask	MKF94K-006
7	KF94 Medical Face Mask	MKF94G-007
8	KF94 Medical Face Mask	MKF94W-008
9	KF94 Medical Face Mask	MHKF94DG-009
10	KF94 Medical Face Mask	MHKF94DB-010
11	KF94 Medical Face Mask	MHKF94WR-011
12	KF94 Medical Face Mask	MHKF94B-012
13	KF94 Medical Face Mask	MHKF94OG-013
14	KF94 Medical Face Mask	MHKF94K-014
15	KF94 Medical Face Mask	MHKF94W-015

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