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.


DEVICE DETAILS

NAME OF DEVICEDIAGNOSTIC X-RAY SYSTEM GF85 (GF85-3P, GF85-SP)
ESTABLISHMENT NAMELAC MEDICAL SUPPLIES SDN BHD
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGC9202825-205276
BRAND NAMESAMSUNG ELECTRONIC CO., LTD
MEDICAL DEVICE CATEGORYMD 1200 - DEVICES FOR IMAGING
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONThe GF85(GF85-3P, GF85-SP) digital X-ray imaging system are to be used to take and store image for diagnosis of patients. It consists of the High voltage generator (HVG), Detector, X-ray tube, Floor mounted stand, Patient table, Wall stand, Collimator and other components etc.
DEVICE INTENDED PURPOSEThe GF85(GF85-3P, GF85-SP) Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
VALIDITY DATE OF REGISTRATION13/06/2025 - 12/06/2030

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Diagnostic X-ray SystemGF85-3P
2Diagnostic X-ray SystemGF85-SP
3X-ray tube H2100X
4X-ray tube H1080X
5X-ray tube H1086X
6X-ray tube E7254FX
7X-ray tube E7252X
8X-ray tube E7843X
9Diagnostic X-ray High Voltage GeneratorCetus 80R01
10Diagnostic X-ray High Voltage GeneratorCetus 65R01
11Diagnostic X-ray High Voltage GeneratorCetus 50R01
12Diagnostic X-ray High Voltage GeneratorCetus 40R03
13CollimatorSDR-OGCL20P
14CollimatorSDR-OGCL21P
15System CabinetSDR-OGCA20P
16System CabinetSDR-OGCA21P
17CIBSDR-OGCI20P
18Digital Flat Panel X-ray DetectorS4335-AW
19Digital Flat Panel X-ray DetectorS4343-AW
20Digital Flat Panel X-ray DetectorFXRD-2530VAW PLUS (Brand name: S3025-AW)
21Digital Flat Panel X-ray DetectorFXRD-2530VAW (Brand name: S3025-AWM)
22Digital Flat Panel X-ray DetectorS4335-AWM
23Digital Flat Panel X-ray DetectorS4343-AWM
24Digital Flat Panel X-ray DetectorF4335-AW
25Digital Flat Panel X-ray DetectorF4343-AW
26Wall StandSDR-OGST21P
27Wall StandSDR-OGST20P
28Tube StandSDR-OGTU20P
29Patient TableSDR-OGTA20P
30Patient TableSDR-OGTA21P
31Auto Stitching StandSDR-OGAS70A
32Weight distribution capSDR-OGWD80U
33Grid HolderSDR-OGGH70A
34Compressing BeltSDR-OGCB20P
35Detector HolderSDR-OGDH70A
36Lateral Support BarSDR-OGBA20P
37Wired X-ray Exposure switchF29-9A
38DAPDGR-ACCSHD