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 DEVICESHENZHEN AEON TECHNOLOGY PULSE OXIMETER
ESTABLISHMENT NAMESUNLIFE MEDIC SDN BHD
REGISTRATION NOGC85721538418
BRAND NAMEA300, A330, A360
DESCRIPTIONSHENZHEN AEON TECHNOLOGY A300 AND A330 PULSE OXIMETER ARE FINGERTIP PULSE OXIMETER, BASED ON ALL DIGITAL TECHNOLOGY, IS INTENDED FOR NON-INVASIVE SPOT-CHECK MEASUREMENT OF SPO2 AND PULSE RATE. THE PRODUCT IS SUITABLE FOR USE IN FAMILY, HOSPITAL (INCLUDING CLINICAL USE IN INTERNIST/SURGERY, ANESTHESIA, PEDIATRICS, INTENSIVE CARE AND ETC.), OXYGEN BAR, SOCIAL MEDICAL ORGANIZATIONS AND PHYSICAL CARE IN SPORTS. SHENZHEN AEON TECHNOLOGY A360 PULSE OXIMETER IS A NON-INVASIVE, HANDHELD PATIENT OXIMETER. IT OPERATES ON ALKALINE OR RECHARGEABLE BATTERY POWER SUPPLY. IT IS COMPACT, SMALL, LIGHT, AND EASY FOR LEARNING AND HANDLING. IT IS SUITABLE FOR MONITORING ADULT AND CHILD PATIENTS. IT IS WIDELY USED IN THE HOSPITAL’S OPERATION ROOM, ICU, CLINIC SECTION OFFICE, OUT-PATIENT DEPARTMENT, SICKROOM, EMERGENCY TREATMENT, AND THE RECOVERY AND HEALTH CARE ORGANIZATIONS, OR IN THE FAMILY NURSING AND IN THE PROCESS OF TRANSPORTING PATIENTS.
INTENDED PURPOSESHENZHEN AEON TECHNOLOGY PULSE OXIMETER IS A DEVICE INTENDED FOR TRANSCUTANEOUS MEASUREMENT OF OXYGEN SATURATION (SPO2) IN THE BLOOD USING LIGHT DETECTION THROUGH A SENSOR. THE LIGHT PRODUCED ILLUMINATES ARTERIAL TISSUE BLOOD, IS RECEIVED BY A DETECTOR AND MEASURED USING THE PRINCIPLE OF SPECTROPHOTOMETRY.
VALIDITY DATE OF REGISTRATION28-12-2017 - 27-12-2022

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1A300 Fingertip Pulse OximeterA300
2A330 Fingertip Pulse OximeterA330
3A360 Handheld Pulse OximeterA360