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 DEVICE FINGERTIP PULSE OXIMETER
ESTABLISHMENT NAMEGASWORLD SDN BHD
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGC93820154517
BRAND NAMEACARE
MEDICAL DEVICE CATEGORYMD 1302 - Monitoring devices of vital physiological parameters
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONPULSE OXIMETER IS A VERY IMPORTANT AND COMMON DEVICE TO CHECK PATIENT'SS BLOOD OXYGEN SATURATION (SPO2) LEVEL AND PULSE RATE. AS A PORTABLE, COMPACT, SIMPLE, RELIABLE AND DURABLE PHYSIOLOGICAL MONITORING DEVICE, HANDHELD PULSE OXIMETER AH- MX CAN GREATLY ENHANCES PATIENT CARE. IT IS WIDELY APPLIED IN CLINIC, HOSPITAL, SOCIAL MEDICAL ORGANIZATIONS, AND FIRST AID AND SO ON.
DEVICE INTENDED PURPOSETHE AX-XX SERIES PULSE OXIMETER IS INTENDED FOR MEASURING AND DISPLAYING FUNCTIONAL OXYGEN SATURATION OF ARTERIAL HEMOGLOBIN (SPO2) AND PULSE RATE FOR ADULT, PEDIATRIC IN FAMILY, HOSPITAL (INCLUDING CLINICAL USE IN INTERNIST/SURGERY, ANESTHESIA, INTENSIVE CARE AND ETC.), OXYGEN BAR, SOCIAL MEDICAL ORGANIZATIONS, PHYSICAL CARE IN SPORTS(IT CAN BE USED BEFORE OR AFTER SPORTS. CONTINUOUSLY MONITORING IS NOT RECOMMENDED.)
VALIDITY DATE OF REGISTRATION07/02/2017 - 06/02/2022

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Fingertip Pulse OximeterAE-O2
2Pediatric Fingertip Pulse Oximeter (Black Panda) AE-C9
3Pediatric Fingertip Pulse Oximeter (Blue Panda) AE-CA
4Pediatric Fingertip Pulse Oximeter (Pink Panda) AE-CB
5Fingertip Pulse OximeterAE-M1
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