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 DEVICEISOLATOR PLUS FACE MASK
ESTABLISHMENT NAMECANTEL MEDICAL (MALAYSIA) SDN. BHD.
REGISTRATION NOGMD9353389617A
BRAND NAMEISOLATOR PLUS
DEVICE GROUPING TYPESINGLE
DEVICE DESCRIPTIONThe N95 respirator masks consists of a polypropylene meltblown filter media sandwiched between non-woven wetlaid outer and inner covers. The mask is secured using two polyester covered non-latex rubber headbands.
DEVICE INTENDED PURPOSEThe N95 surgical mask is intended to be worn by healthcare personnel during surgical procedures to protect both the pateint and healthcare personnel from the transfer of microorganisms, body fluids, and particulate materials. Intended use includes use as a procedure mask, isolation mask and/or dental face mask.
VALIDITY DATE OF REGISTRATION16/01/2022 - 15/01/2027

LIST OF DEVICE

NONAME OF DEVICEDEVICE IDENTIFIER
1ISOLATOR PLUS FACE MASKGPRN95