| No | Date received | Affected Medical Device | MDA Reference No. | MDA Registration No. |
Local Establishment Contact Detail | Copy of FSN |
|---|---|---|---|---|---|---|
| 1 | 2026-04-22 | ABL8XX SERIES BLOOD GAS ANALYZERS | MDA/FCA/P1757-22640254-2026 | IVDB7902324-176952 | RADIOMETER MALAYSIA SDN. BHD. NO.18 PJ51 BUSINESS PARK JALAN TANDANG 51/205A SEKSYEN 51 46050 SELANGOR 603-74955929 jngwei.chan@radiometer.my |
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| 2 | 2026-04-22 | ABL90 FLEX | MDA/FCA/P1758-88425376-2026 | IVDC5590952317 | RADIOMETER MALAYSIA SDN. BHD. NO.18 PJ51 BUSINESS PARK JALAN TANDANG 51/205A SEKSYEN 51 46050 SELANGOR 603-74955929 jngwei.chan@radiometer.my |
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| 3 | 2026-04-20 | XPERT CARBA-R ASSAY | MDA/FCA/P1753-72098743-2026 | IVDC6457221-74902 | RADIOMETER MALAYSIA SDN. BHD. NO.18 PJ51 BUSINESS PARK JALAN TANDANG 51/205A SEKSYEN 51 46050 SELANGOR 603-74955929 jngwei.chan@radiometer.my |
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| 4 | 2026-04-13 | MAGNETOM PRISMA | MDA/FCA/P1747-97632639-2026 | GB75698797118 | 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 | 2026-04-09 | SYNCHROMED II PROGRAMMABLE PUMP SYSTEM AND ACCESSORIES | MDA/FCA/P1737-84052626-2026 | GD6185822-96376 | 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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| 6 | 2026-04-07 | VITROS CHEMISTRY PRODUCTS ELECTROLYTES REAGENTS | MDA/FCA/P1733-55180019-2026 | IVDB7599223-142604 | T T MEDICAL MANAGEMENT SDN BHD A-3A-03 EKOCHERAS, NO. 693, BATU 5 JALAN CHERAS 56000 WILAYAH PERSEKUTUAN 603-91345391 ttcsdt05@gmail.com |
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| 7 | 2026-03-30 | ANEURYSMFLOW | MDA/FCA/P1727-77143402-2026 | GB16499497817 | 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 | 2026-03-27 | VITROS IMMUNODIAGNOSTIC PRODUCTS FERTILITY & PREGNANCY HORMONES & PROTEINS | MDA/FCA/P1725-75023993-2026 | IVDB7258323-129195 | T T MEDICAL MANAGEMENT SDN BHD A-3A-03 EKOCHERAS, NO. 693, BATU 5 JALAN CHERAS 56000 WILAYAH PERSEKUTUAN 603-91345391 ttcsdt05@gmail.com |
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| 9 | 2026-03-27 | PALAMIX VACUUM MIXING SYSTEM | MDA/FCA/P1726-81262285-2026 | GB4398519-36101 | ACX HEALTH SDN. BHD. BO1-A-09-1, MENARA 2, KL ECO CITY, 3 JALAN BANGSAR 59200 WILAYAH PERSEKUTUAN KUALA LUMPUR 603-92125420 regulatory.my@pharmatomarket.com |
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| 10 | 2026-03-26 | LIAISON® RUBELLA IGM | MDA/FCA/P1720-91186536-2026 | IVDC8532923-128419 | DIAGNOSTICARE SDN BHD NO 1, JALAN SERINDIT 2 BANDAR PUCHONG JAYA PUCHONG 47100 SELANGOR 603-80842911 zaidi.jantan@diagnosticare.com.my |
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