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.


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DEVICE DETAILS

NAME OF DEVICERAINBOW PULSE OXIMETER
ESTABLISHMENT NAMENYPRAX BUSINESS SOLUTIONS
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGC430321043618
BRAND NAMEMASIMO
MEDICAL DEVICE CATEGORYMD 1302 - Monitoring devices of vital physiological parameters
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONTHE RADICAL-7 PULSE CO-OXIMETER IS A NONINVASIVE MONITOR THAT MEASURES ARTERIAL OXYGEN SATURATION (SPO2), PULSE RATE (PR), AND PERFUSION INDEX (PI), ALONG WITH OPTIONAL MEASUREMENTS OF HEMOGLOBIN (SPHB)*, CARBOXYHEMOGLOBIN (SPCO)*, TOTAL OXYGEN CONTENT (SPOC), METHEMOGLOBIN (SPMET)*, PLETH VARIABILITY INDEX (PVI), OXYGEN RESERVE INDEX (ORI)*, ACOUSTIC RESPIRATION RATE (RRA)*, AND PLETH RESPIRATION RATE (RRP)*.
DEVICE INTENDED PURPOSETHE RADICAL-7 PULSE CO-OXIMETER CAN BE USED AS EITHER A HANDHELD OR A STANDALONE MONITOR. THE RADICAL-7 PULSE CO-OXIMETER FEATURES A TOUCHSCREEN THAT CONTINUOUSLY DISPLAYS NUMERIC VALUES FORARTERIAL OXYGEN SATURATION (SPO2), PULSE RATE (PR), AND PERFUSION INDEX (PI), ALONG WITH OPTIONAL MEASUREMENTS OF HEMOGLOBIN (SPHB)*, CARBOXYHEMOGLOBIN (SPCO)*, TOTAL OXYGEN CONTENT (SPOC), METHEMOGLOBIN (SPMET)*, PLETH VARIABILITY INDEX (PVI), OXYGEN RESERVE INDEX (ORI)*, ACOUSTIC RESPIRATION RATE (RRA)*, AND PLETH RESPIRATION RATE (RRP)*.
VALIDITY DATE OF REGISTRATION02/08/2023 - 01/08/2028

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