| No | Date received | Affected Medical Device | MDA Reference No. | MDA Registration No. |
Local Establishment Contact Detail | Copy of FSN |
|---|---|---|---|---|---|---|
| 1 | 2025-04-24 | IRON2 | MDA/FCA/P1277-63057361-2025 | IVDB6137023-142666 | ROCHE DIAGNOSTICS (M) SDN. BHD. B-20-1, THE ASCENT, PARADIGM MALL NO. 1, JALAN SS 7/26A, KELANA JAYA 47301 SELANGOR 603-79672388 wai_chin.koh@roche.com |
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| 2 | 2025-04-16 | ATELLICA® IM HOMOCYSTEINE (HCY) | MDA/FCA/P1271-41660423-2025 | IVDB59216279518 | SIEMENS HEALTHCARE SDN. BHD. BLOCK A, LEVEL 33A, MENARA THE MET, NO. 20 JALAN DUTAMAS 2, 50480 KUALA LUMPUR, MALAYSIA 50480 WILAYAH PERSEKUTUAN KUALA LUMPUR 6012-2826902 yenli.lam@siemens-healthineers.com |
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| 3 | 2025-04-16 | ADVIA CENTAUR® HCY | MDA/FCA/P1272-71088702-2025 | IVDB5671151317 | SIEMENS HEALTHCARE SDN. BHD. BLOCK A, LEVEL 33A, MENARA THE MET, NO. 20 JALAN DUTAMAS 2, 50480 KUALA LUMPUR, MALAYSIA 50480 WILAYAH PERSEKUTUAN KUALA LUMPUR 6012-2826902 yenli.lam@siemens-healthineers.com |
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| 4 | 2025-04-08 | FRED EASYPORT | MDA/FCA/P1254-27269859-2025 | GC734506016 | 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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| 5 | 2025-04-08 | FIBRINOGEN-C ASSAY | MDA/FCA/P1255-65543931-2025 | IVDB75891303518 | STRAITS SCIENTIFIC (M) SDN BHD NO.10, JALAN NIRWANA 37, TAMAN NIRWANA 68000 SELANGOR 603-92847170 straits@3s.com.my |
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| 6 | 2025-04-02 | CARESTATION 650 A1, CARESTATION 650C A1, CARESTATION 620 A1 | MDA/FCA/P1251-86707162-2025 | GC5901122-104148 | 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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| 7 | 2025-04-02 | CARESTATION 700 SERIES | MDA/FCA/P1252-92049677-2025 | GC2333221-51495 | 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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| 8 | 2025-03-27 | Centricity High Acuity Critical Care | MDA/FCA/P1248-30954142-2025 | GA2352020-44975 | 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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| 9 | 2025-03-26 | EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM | MDA/FCA/P1246-84903910-2025 | GC2869522-88521 | MEDTRONIC MALAYSIA SDN BHD B-23-1, LEVEL 23, THE ASCENT, PARADIGM, NO 1 JALAN SS7/26A, KELANA JAYA 47301 SELANGOR 603-78838000 dl.myreg@medtronic.com |
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| 10 | 2025-03-25 | ATELLICA® CH REVISED C‑REACTIVE PROTEIN (RCRP) | MDA/FCA/P1245-61271022-2025 | IVDB10942623-142160 | SIEMENS HEALTHCARE SDN. BHD. BLOCK A, LEVEL 33A, MENARA THE MET, NO. 20 JALAN DUTAMAS 2, 50480 KUALA LUMPUR, MALAYSIA 50480 WILAYAH PERSEKUTUAN KUALA LUMPUR 6012-2826902 yenli.lam@siemens-healthineers.com |
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