| No | Date received | Affected Medical Device | MDA Reference No. | MDA Registration No. |
Local Establishment Contact Detail | Copy of FSN |
|---|---|---|---|---|---|---|
| 1 | 2026-06-02 | INTRABEAM 600 | MDA/FCA/P1808-59002357-2026 | GD779388116 | CARL ZEISS SDN BHD AXIS BUSINESS CAMPUS, UNIT G.02, BLOCK B, NO.13 & 13A, JALAN 51A/225, SEKSYEN 51A, 46100 PETALING JAYA, SELANGOR 46100 SELANGOR 603-79326600 siao-yi.won@zeiss.com |
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| 2 | 2026-05-21 | O-ARM O2 IMAGING SYSTEM AND ACCESSORIES | MDA/FCA/P1804-70792708-2026 | GC10794122-104946 | 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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| 3 | 2026-05-20 | IMPELLA CP® WITH SMARTASSIST® SET | MDA/FCA/P1802-62492946-2026 | GD9474523-140294 | DCH AURIGA (M) SDN BHD LOT 6, PERSIARAN PERUSAHAAN, SEKSYEN 23, SHAH ALAM, 40300 SELANGOR 603-55438725 LimLiangJun@dchauriga.com |
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| 4 | 2026-05-20 | ARTIS ICONO FAMILY | MDA/FCA/P1803-64531942-2026 | GC7669520-43102 | 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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| 5 | 2026-05-14 | APEXPRO TELEMETRY SYSTEM | MDA/FCA/P1799-35789378-2026 | GC96351485517 | 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@gehealthcare.com |
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| 6 | 2026-05-12 | MMT TRYTABLE TU2000 | MDA/FCA/P1789-92320142-2026 | GA2807724-178157 | MEDI-LIFE (M) SDN. BHD. NO. 10 (2ND FLOOR) JALAN PENDAFTAR U1/54 TEMASYA INDUSTRIAL PARK, SHAH ALAM 40150 SELANGOR 603-55692699 pamela.lim@medi-life.com.my |
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| 7 | 2026-05-12 | MERLIN PATIENT CARE SYSTEM & PACING SYSTEM ANALYZER | MDA/FCA/P1790-92552622-2026 | GC9743622-98481 | ABBOTT MEDICAL (MALAYSIA) SDN. BHD. 27-02, LEVEL 27, IMAZIUM, NO. 8, JALAN SS 21/37, DAMANSARA UPTOWN 47400 SELANGOR 603-79887000 RegulatoryMY@abbott.com |
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| 8 | 2026-05-12 | ATELLICA® CH LACTATE_3 (LAC_3) | MDA/FCA/P1792-82303684-2026 | IVDB5904622-106142 | 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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| 9 | 2026-05-08 | ATELLICA® IM HOMOCYSTEINE (HCY) | MDA/FCA/P1782-75693614-2026 | 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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| 10 | 2026-05-05 | AZURION 3 | MDA/FCA/P1772-82223106-2026 | GC99381544218 | PHILIPS MALAYSIA SENDIRIAN BERHAD ANCHOR SPACE 3 & 4, CO-LABS COWORKING, LEVEL 11, MENARA KEN TTDI, NO. 37, JALAN BURHANUDDIN HELMI, TAMAN TUN DR ISMAIL 60000 WILAYAH PERSEKUTUAN KUALA LUMPUR 6019-3220792 zam.zarina@philips.com |
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