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 DEVICEN95 Face Mask
ESTABLISHMENT NAMEHALYARD MALAYSIA SDN BHD
REGISTRATION NOGA9457719-32152
BRAND NAMEHALYARD*
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONN95 Face Masks are NIOSH approved and offers a high level of respiratory protection with an effective facial fit. These masks provide optimal fluid protection and come in a choice of styles and sizes.
DEVICE INTENDED PURPOSEN95 Face Masks are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
VALIDITY DATE OF REGISTRATION05/08/2024 - 04/08/2029

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1FLUIDSHIELD* 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, Regular Size46727
2FLUIDSHIELD* 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, Regular Size, Individually Packaged46728
3FLUIDSHIELD* 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and SO SOFT* Lining, Orange, Regular Size46767
4FLUIDSHIELD* 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, Small46827
5FLUIDSHIELD* 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, Small Size, Individually Packaged46828
6FLUIDSHIELD* 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and SO SOFT* Lining, Orange, Small46867
7FLUIDSHIELD* 2 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, White, Regular Size62126
8FLUIDSHIELD* 2 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, White, Small62355
9FLUIDSHIELD* 3 Ported N95 Particulate Filter Respirator with SO SOFT* Lining, Orange, Regular Size99175
10FLUIDSHIELD* 3 Ported N95 Particulate Filter Respirator with SAFETY SEAL and SO SOFT* Lining, Orange, Regular Size99178
11FLUIDSHIELD* 3 Ported N95 Particulate Filter Respirator with SO SOFT* Lining, Orange, Small Size99181
12FLUIDSHIELD* 3 Ported N95 Particulate Filter Respirator with SAFETY SEAL and SO SOFT* Lining, Orange, Small Size99184