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 DEVICEAUTOMATED CLINICAL CHEMISTRY ANALYZER
ESTABLISHMENT NAMEFUJIFILM (MALAYSIA) SDN. BHD.
REGISTRATION NOIVDA5572198918
BRAND NAMEFUJIFILM
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONFUJI DRI-CHEM AUTOMATED CLINICAL CHEMISTRY ANALYZER PERFORMS A VERY SIMPLE BIOCHEMICAL TEST SYSTEM THAT CAN MEASURE THE CONCENTRATION OR ACTIVITY OF SPECIFIC SUBSTANCE OR ENZYMES BY A DROP OF BLOOD PLASMA/SERUM OR URINE ON A SMALL SLIDE CONTAINING DRY REAGENTS.
DEVICE INTENDED PURPOSEFOR IN VITRO DIAGNOSTIC USE. THE DEVICE IS USED TO QUANTITATES THE CONCENTRATION OR THE ACTIVITY OF THE COMPONENTS IN BLOOD/URINE BY USING THE FUJI DRI-CHEM SLIDES (DRIED REAGENTS).
VALIDITY DATE OF REGISTRATION28/12/2017 - 27/12/2022

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1FUJI DRI-CHEM NX500FDC NX500 E MJ
2FUJI DRI-CHEM NX500iFDC NX500 I E J
3FUJI DRI-CHEM 7000iFDC 7000 I E 2
4FUJI DRI-CHEM 4000ie FDC 4000 I E
5FUJI DRI-CHEM NX700FDC NX700 E
6FUJI DRI-CHEM NX700iFDC NX700 I E
7FUJI DRI-CHEM NX600FDC NX600 E
8FUJI DRI-CHEM NX600iFDC NX600 I E
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