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DEVICE DETAILS

NAME OF DEVICEWRIST BLOOD PRESSURE MONITOR
ESTABLISHMENT NAMEHUAWEI TECHNOLOGIES (MALAYSIA) SDN BHD
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGB2822524-166644
BRAND NAMEHUAWEI
MEDICAL DEVICE CATEGORYMD 0100 - GENERAL NON-ACTIVE, NON-IMPLANTABLE MEDICAL DEVICES
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONThe Wrist Blood Pressure Monitor manufactured by Huawei Device Co., Ltd. (hereafter referred to as 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.
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 REGISTRATION19/03/2024 - 18/03/2029

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Wrist Blood Pressure MonitorMLY-B10
2Wrist Blood Pressure MonitorMLY-B11
3Wrist Ambulatory Blood Pressure MonitorLCA-B10
4Wrist Ambulatory Blood Pressure MonitorLCA-B11
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