| No | Date received | Affected Medical Device | MDA Reference No. | MDA Registration No. |
Local Establishment Contact Detail | Copy of FSN |
|---|---|---|---|---|---|---|
| 1 | 2026-09-15 | CENTRICITY HIGH ACUITY ANESTHESIA | MDA/FCA/P1926-13370143-2026 | GMD29146275517A | 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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| 2 | 2026-09-07 | COLLAGEN COATED VASCULAR GRAFTS AND PATCHES | MDA/FCA/P1920-77683839-2026 | GD8807187616 | RBD HEALTHCARE SDN BHD NO. 8 JALAN NILAM 1/3 TAMAN PERINDUSTRIAN TEKNOLOGI TINGGI SUBANG 40000 SELANGOR 603-56332010 sookpei@rbdhealthcare.com |
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| 3 | 2026-09-01 | INGENIA 1.5T, INGENIA 3.0T | MDA/FCA/P1915-19853827-2026 | GB63162332517 | 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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| 4 | 2026-09-01 | INGENIA AMBITION | MDA/FCA/P1916-63649830-2026 | GB2356219-30045 | 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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| 5 | 2026-09-01 | MR 5300 | MDA/FCA/P1917-24375756-2026 | GB2458922-104130 | 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 | 2026-09-01 | MR 5300 | MDA/FCA/P1918-32622057-2026 | GB2458922-104130 | 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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| 7 | 2026-08-27 | SPECTRAL CT | MDA/FCA/P1911-65549958-2026 | GC6307722-96412 | 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 | 2026-08-27 | INTELLIVUE PATIENT MONITOR MX750 & MX850 | MDA/FCA/P1913-29885875-2026 | GC2975220-43026 | 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 | 2026-08-24 | HEMOSTASIS DEVICES | MDA/FCA/P1910-67514500-2026 | GB8677723-144784 | COOK ASIA (MALAYSIA) SDN BHD UNIT 1602, LEVEL 16, UPTOWN 1, NO.1, JALAN SS 21/58, DAMANSARA UTAMA 47400 SELANGOR 603-76693889 RA-Malaysia@CookMedical.com |
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| 10 | 2026-08-19 | ATELLICA® CH REVISED C‑REACTIVE PROTEIN (RCRP) | MDA/FCA/P1908-48458196-2026 | 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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