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DEVICE DETAILS

NAME OF DEVICEWRIST BLOOD PRESSURE MONITOR
ESTABLISHMENT NAMEHUAWEI TECHNOLOGIES (MALAYSIA) SDN BHD
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGB9847522-109056
BRAND NAMEHUAWEI
MEDICAL DEVICE CATEGORYMD 1100 - GENERAL ACTIVE MEDICAL DEVICES
DEVICE GROUPING TYPESINGLE
DEVICE DESCRIPTIONThe Wrist Blood Pressure Monitor manufactured by Huawei is a reusable, active, non-sterile, non-invasive and non-implantable device for measuring adults’ blood pressure and pulse rate. It is a home-use device prohibited from use in MRI (magnetic resonance imaging) environment. This wrist blood pressure monitor has the following features: • Maximum storage of 60 sets of measurement data • Systolic, diastolic blood pressure & pulse rate display • Date/time indication
DEVICE INTENDED PURPOSEThe Wrist Blood Pressure Monitor is a digital self-monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 13.0 cm to 20.0 cm (5.12–7.87 inches).
VALIDITY DATE OF REGISTRATION15/11/2022 - 14/11/2027

LIST OF DEVICE

NONAME OF DEVICEDEVICE IDENTIFIER
1WRIST BLOOD PRESSURE MONITORMLY-B10
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