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 DEVICEBI-HAEMOSOL (SOLUTION A)
ESTABLISHMENT NAMEDUOPHARMA (M) SDN BHD
ROLE OF ESTABLISHMENTMANUFACTURER
REGISTRATION NOGC364031258019
BRAND NAMEBI-HAEMOSOL
MEDICAL DEVICE CATEGORYMD 0102 - Non-active devices for injection, infusion, transfusion and dialysis
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONALMOST COLOURLESS SOLUTION CONTAINING ESSENTIALS SALTS (DIALYSATE); SODIUM CHLORIDE, CALCIUM CHLORIODE, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE,GLACIAL ACETIC ACID AND WATER FOR INJECTION.
DEVICE INTENDED PURPOSEBI-HAEMOSOL IS INTENDED AS HEMODIALYSIS SOLUTION WHERE THE PRODUCT IS USED TO REMOVE ACCUMULATED WASTE AND EXCESS WATER FROM THE BODY OF A PERSON WHOSE HAVING DISEASED KIDNEY NOT ABLE TO FUNCTION. INDICATED FOR ACUTE RENAL FAILURE; CHRONIC RENAL FAILURE; OVERHYDRATION; INTOXICATIONS; ADJUSTMENT OF ACID-BASE AND ELECTROLYE BALANCE.
VALIDITY DATE OF REGISTRATION28/12/2023 - 27/12/2028

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1BI-HAEMOSOL 1ABI-HAEMOSOL 1A
2BI-HAEMOSOL 2ABI-HAEMOSOL 2A
3BI-HAEMOSOL 3ABI-HAEMOSOL 3A
4BI-HAEMOSOL 5ABI-HAEMOSOL 5A
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