| No | Date received | Affected Medical Device | MDA Reference No. | MDA Registration No. |
Local Establishment Contact Detail | Copy of FSN |
|---|---|---|---|---|---|---|
| 1 | 2026-03-25 | ATELLICA® IM FREE PROSTATE‑SPECIFIC ANTIGEN (FPSA) | MDA/FCA/P1718-58514099-2026 | IVDC82776266818 | 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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| 2 | 2026-03-19 | AFFERA™ INTEGRATED MAPPING SYSTEM | MDA/FCA/P1712-31218074-2026 | GD9452125-218019 | 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 | 2026-03-18 | ELECTROSURGICAL GENERATOR ESG-400 | MDA/FCA/P1710-45933338-2026 | GC94229142417 | OLYMPUS (MALAYSIA) SDN. BHD. UNIT T2-L05-1, PJ33, NO. 3, JALAN PROFESSOR KHOO KAY KIM, SEKSYEN 13 47301 SELANGOR 603-76508990 mes-ra.oml@olympus.com |
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| 4 | 2026-03-06 | IMPELLA CP® WITH SMARTASSIST® SET | MDA/FCA/P1702-89676739-2026 | 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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| 5 | 2026-03-05 | PHILIPS VUE PACS | MDA/FCA/P1699-68534877-2026 | GB18651834218 | 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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| 6 | 2026-03-04 | AFINION HBA1C | MDA/FCA/P1697-28229741-2026 | IVDB67848304818 | ABBOTT DIAGNOSTICS HEALTH SDN BHD UNIT 27-02, IMAZIUM, NO. 8, JALAN SS21/37, DAMANSARA UPTOWN, 47400 SELANGOR 603-79887000 winnielinlin.hii@abbott.com |
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| 7 | 2026-03-03 | AZURION 5 | MDA/FCA/P1694-24420952-2026 | GC10785320-48186 | 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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| 8 | 2026-03-03 | AZURION 7 | MDA/FCA/P1695-44042981-2026 | GC82521235717 | 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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| 9 | 2026-03-03 | AZURION BIPLANE | MDA/FCA/P1696-32986984-2026 | GC59959884718 | 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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| 10 | 2026-03-02 | AZURION 3 | MDA/FCA/P1693-95365592-2026 | 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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