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DEVICE DETAILS

NAME OF DEVICEBLOOD PRESSURE MONITOR MEDISENSE X9
ESTABLISHMENT NAMEPFLEGE MEDICAL SUPPLIES SDN. BHD.
ROLE OF ESTABLISHMENTMANUFACTURER
REGISTRATION NOGB10255725-216438
BRAND NAMEPROFIX
MEDICAL DEVICE CATEGORYMD 1100 - GENERAL ACTIVE MEDICAL DEVICES
DEVICE GROUPING TYPESINGLE
DEVICE DESCRIPTIONPROFIX Blood Pressure Monitor Medisense X9 consists of eight main components and accessories, including LCD, Keys, Pump, Cuff, MCU, Transducer, Energy Source and Case. This is an automatic non-invasive blood pressure monitor which can be driven by 4 AA batteries or type-C USB (optional). It uses an inflatable cuff which is wrapped around the patient’s upper arm to measure the systolic and diastolic blood pressure as well as the pulse rate of adult at household, not for neonate or pregnancy.
DEVICE INTENDED PURPOSEPROFIX Blood Pressure Monitor Medisense X9 is intended purposed to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.
VALIDITY DATE OF REGISTRATION13/11/2025 - 12/11/2030

LIST OF DEVICE

NONAME OF DEVICEDEVICE IDENTIFIER
1BLOOD PRESSURE MONITOR MEDISENSE X9MEDISENSE X9
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