Public View Listing For FCA

No Date received Affected Medical Device MDA Reference No. MDA Registration No. Local Establishment Contact Detail Copy of FSN
1 2024-05-24 VITROS IMMUNOCHEMISTRY ANEMIA MDA/FCA/P0808-24838188-2024 IVDB7591723-145140 T T MEDICAL MANAGEMENT SDN BHD
A-3A-03 EKOCHERAS, NO. 693, BATU 5 JALAN CHERAS,
56000
WILAYAH PERSEKUTUAN
603-91345391
ar@ttmedical.com.my
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2 2024-05-10 REAL INTELLIGENCE CORI MDA/FCA/P0792-63094108-2024 GB8636421-71478 SMITH & NEPHEW HEALTHCARE SDN BERHAD
LEVEL 17, TOWER 3, AVENUE 7, JALAN KERINCHI, BANGSAR SOUTH
59200
KUALA LUMPUR
603-22431200
fariza.zainulabidin@smith-nephew.com
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3 2024-05-09 HEMODYNAMIC APPLICATION MDA/FCA/P0787-87003714-2024 GB685291134018 PHILIPS MALAYSIA SDN BERHAD
LEVEL 9, MENARA AXIS, NO 2, JALAN 51A/223 PETALING JAYA
46100
SELANGOR
6019-3220792
zam.zarina@philips.com
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4 2024-05-03 AUTOCAT 3 MDA/FCA/P0780-87733439-2024 GD877091305219 TELEFLEX MEDICAL SDN.BHD
LOT NO PT 2577, JALAN PERUSAHAAN 4, KAMUNTING INDUSTRIAL ESTATE
34600
PERAK
605-8295111
yihui.lim@teleflex.com
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5 2024-05-03 AUTOCAT 3 MDA/FCA/P0782-56685862-2024 GD9475223-139423 TELEFLEX MEDICAL SDN.BHD
LOT NO PT 2577, JALAN PERUSAHAAN 4, KAMUNTING INDUSTRIAL ESTATE
34600
PERAK
605-8295111
yihui.lim@teleflex.com
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6 2024-05-03 ARROW AUTOCAT 2 WAVE INTRA-AORTIC BALLOON PUMP (IABP) SYSTEM MDA/FCA/P0783-84495139-2024 GD44414701118 TELEFLEX MEDICAL SDN.BHD
LOT NO PT 2577, JALAN PERUSAHAAN 4, KAMUNTING INDUSTRIAL ESTATE
34600
PERAK
605-8295111
yihui.lim@teleflex.com
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7 2024-04-30 INGENIA CX MDA/FCA/P0774-50607103-2024 GB25631685418 PHILIPS MALAYSIA SDN BERHAD
LEVEL 9, MENARA AXIS, NO 2, JALAN 51A/223 PETALING JAYA
46100
SELANGOR
6019-3220792
zam.zarina@philips.com
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8 2024-04-30 MR 5300 MDA/FCA/P0775-62896718-2024 GB2458922-104130 PHILIPS MALAYSIA SDN BERHAD
LEVEL 9, MENARA AXIS, NO 2, JALAN 51A/223 PETALING JAYA
46100
SELANGOR
6019-3220792
zam.zarina@philips.com
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9 2024-04-30 CARESCAPE CANVAS PATIENT MONITORS MDA/FCA/P0777-99166987-2024 GC9975923-151743 GE HEALTHCARE SDN. BHD
SUITE 1A-1, LEVEL 1 BLOCK 1A,, PLAZA SENTRAL JALAN STESEN SENTRAL 5, KUALA LUMPUR SENTRAL 50470, KUALA LUMPUR MALAYSIA
50470
KUALA LUMPUR
603-22671888
premarket.my@ge.com
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10 2024-04-29 BP-200 PLUS MDA/FCA/P0771-52224475-2024 GB72718125917 SCHILLER ASIA PACIFIC SDN. BHD.
NO.10, JALAN ARA SD 7/3B, BANDAR SRI DAMANSARA,
52200
WILAYAH PERSEKUTUAN KUALA LUMPUR
603-62723033
thiamhong.lim@schiller.com.my
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