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 DEVICEPULSE OXIMETER (H100N, H100B)
ESTABLISHMENT NAMEKORMED RESOURCES PLT.
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGC374031090618
BRAND NAMEEDAN
MEDICAL DEVICE CATEGORYMD 1300 - MONITORING DEVICES
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONH100B AND H100N (BOTH IN FIGURE 1) ARE MODELS OF H100 SERIES PULSE OXIMETER. IT DISPLAYS SPO2 VALUE, PULSE RATE VALUE, PLETHYSMOGRAM, BAR GRAPH, TEMPERATURE, ETC. H100B IS INSTALLED WITH EDAN SPO2 MODULE INSIDE. H100N IS INSTALLED WITH NELLCOR SPO2 MODULE AND THE MANUFACTURER’S TEMP MODULE INSIDE. IT INTEGRATES PARAMETER MODULE, DISPLAY AND DATA OUTPUT FUNCTIONS.
DEVICE INTENDED PURPOSETHE H100B PULSE OXIMETER IS INTENDED FOR CONTINUOUS MONITORING OR SPOT-CHECKING OF FUNCTIONAL ARTERIAL OXYGEN SATURATION (SPO2) AND PULSE RATE OF SINGLE ADULT, PEDIATRIC OR NEONATE PATIENT IN HOSPITALS, INTRA-HOSPITAL TRANSPORT AND HOSPITAL TYPE FACILITIES.
VALIDITY DATE OF REGISTRATION26/09/2018 - 25/09/2023

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Pulse OximeterH100B
2Pulse OximeterH100N
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