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DEVICE DETAILS

NAME OF DEVICEPULSE OXIMETER
ESTABLISHMENT NAMEMEDISANA MALAYSIA SDN BHD
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGC5975226-232412
BRAND NAMEMEDISANA
MEDICAL DEVICE CATEGORYMD 1100 - GENERAL ACTIVE MEDICAL DEVICES
DEVICE GROUPING TYPESINGLE
DEVICE DESCRIPTIONMedisana Pulse Oximeter (PM 180) determines SpO2 by measuring the absorption of red & infrared light passing through perfused tissue. Changes in absorption caused by the pulsation of blood in the vascular bed are used to determine SpO2 reading and pulse rate.
DEVICE INTENDED PURPOSEThe Fingertip Pulse Oximeter are intended for measuring functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adults as non-invasive spot checking in home environment. It is designed for fingers between 0.8cm and 2.5cm (0.3 inches to 1 inches) and for patients during no-motion condition.
VALIDITY DATE OF REGISTRATION13/05/2026 - 12/05/2031

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