| No | Date received | Affected Medical Device | MDA Reference No. | MDA Registration No. |
Local Establishment Contact Detail | Copy of FSN |
|---|---|---|---|---|---|---|
| 1 | 2026-07-23 | AZURION BIPLANE | MDA/FCA/P1874-94285514-2026 | 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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| 2 | 2026-07-23 | AZURION 5 | MDA/FCA/P1875-51651556-2026 | 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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| 3 | 2026-07-23 | AZURION 7 | MDA/FCA/P1876-51985796-2026 | 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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| 4 | 2026-07-21 | AZURION 3 | MDA/FCA/P1865-64805937-2026 | 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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| 5 | 2026-07-21 | AZURION 5 | MDA/FCA/P1867-12909917-2026 | 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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| 6 | 2026-07-21 | AZURION 7 | MDA/FCA/P1868-60142970-2026 | 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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| 7 | 2026-07-21 | AZURION BIPLANE | MDA/FCA/P1869-66579756-2026 | 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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| 8 | 2026-07-17 | Fully Automated Urine Particle Digital Imaging Device UD-10 | MDA/FCA/P1864-52305113-2026 | IVD7378939616A | SYSMEX (MALAYSIA) SDN. BHD. LEVEL 15, SUBPLACE BOULEVARD, PUSAT KOMERSIL VESTLAND, NO. 6, JALAN JURUANALISIS U1/35, SEKSYEN U1, 40150 SHAH ALAM, SELANGOR 40150 SELANGOR 603-58705288 Ho.Janice@sysmex.com.my |
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| 9 | 2026-07-03 | ELIA PHADIA 200 CONTROLS | MDA/FCA/P1853-93915629-2026 | IVDB2265720-49554 | BIOMARKETING SERVICES (M) SDN BHD NO. 13 JALAN CEMPAKA SD 12/5, PJU 9, BANDAR SRI DAMANSARA, 52200 WILAYAH PERSEKUTUAN KUALA LUMPUR 603-62870066 regulatory.my@biomedglobal.com |
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| 10 | 2026-07-01 | AFFERA™ INTEGRATED MAPPING SYSTEM | MDA/FCA/P1851-62017941-2026 | 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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