| No | Date received | Affected Medical Device | MDA Reference No. | MDA Registration No. | Local Establishment Contact Detail | Copy of FSN |
|---|---|---|---|---|---|---|
| 1 | 2024-06-25 | NIM VITAL SYSTEM | MDA/FCA/P0870-44163701-2024 | GB5890720-48798 | 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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| 2 | 2024-06-24 | WELCH ALLYN BRAUN THERMOSCAN EAR THERMOMETER PRO6000 | MDA/FCA/P0866-53838178-2024 | GB57417827518 | WELCH ALLYN MALAYSIA SDN BHD LOT NO. B-21-3, LEVEL 21, THE ASCENT PARADIGM, NO. 1, JALAN SS7/26A, KELANA JAYA, PETALING JAYA, SELANGOR 47301 SELANGOR 6012-78843341 nukun_sim@baxter.com |
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| 3 | 2024-06-21 | ACCESS ULTRASENSITIVE HGH | MDA/FCA/P0864-11698907-2024 | IVDB10306623-125414 | BECKMAN COULTER MALAYSIA SDN. BHD. NO. 18, JALAN TANDANG 51/205A, SEKSYEN 51 46050 SELANGOR 603-77728256 nbintiabdaziz@beckman.com |
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| 4 | 2024-06-18 | ELECTROSURGICAL GENERATOR ESG-410 | MDA/FCA/P0858-49294013-2024 | GC5599621-63426 | 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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| 5 | 2024-06-11 | MEDICAL VENTILATOR | MDA/FCA/P0825-19855036-2024 | GC25545945118 | STAR MEDIK SDN BHD NO 43, JALAN TIARA SENTRAL 2, NILAI UTAMA ENTERPRISE PARK 71800 NEGERI SEMBILAN 606-7998113 starmedik@gmail.com |
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| 6 | 2024-06-11 | AFINION 2 | MDA/FCA/P0826-23942254-2024 | IVD27240868318A | 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 | 2024-06-11 | COBAS EGFR MUTATION TEST V2 | MDA/FCA/P0846-70119633-2024 | IVDC7183621-56115 | ROCHE DIAGNOSTICS (M) SDN. BHD. B-20-1, THE ASCENT, PARADIGM MALL NO. 1, JALAN SS 7/26A, KELANA JAYA 47301 SELANGOR 603-79672388 wai_chin.koh@roche.com |
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| 8 | 2024-05-10 | MDA/FCA/P0792-63094108-2024 | SMITH & NEPHEW HEALTHCARE SDN BERHAD LEVEL 17, TOWER 3, AVENUE 7, JALAN KERINCHI, BANGSAR SOUTH 59200 KUALA LUMPUR 603-22431200 fariza.zainulabidin@smith-nephew.com |
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| 9 | 2024-05-09 | GETINGE FLOW-I ANESTHESIA SYSTEM | MDA/FCA/P0780-89749173-2024 | GC25644700318 | IDS MEDICAL SYSTEMS (M) SDN BHD 8, JALAN PENSYARAH U1/28, HICOM GLENMARIE INDUSTRIAL PARK, 40150 SELANGOR 603-50225225 NurSyahirahFatini@idsmed.com |
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| 10 | 2024-05-09 | HEMODYNAMIC APPLICATION | MDA/FCA/P0787-87003714-2024 | GB685291134018 | PHILIPS MALAYSIA SDN BERHAD LEVEL 9, MENARA AXIS, NO 2, JALAN 51A/223 PETALING JAYA 46100 SELANGOR 6019-3220792 zam.zarina@philips.com |
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