| No | Date received | Affected Medical Device | MDA Reference No. | MDA Registration No. | Local Establishment Contact Detail | Copy of FSN |
|---|---|---|---|---|---|---|
| 1 | 2025-03-24 | SYNGO.VIA VB30 | MDA/FCA/P1239-63380128-2025 | GB120001319219 | 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 | 2025-03-21 | ACCESS UNCONJUGATED ESTRIOL | MDA/FCA/P1242-37020681-2025 | IVDB2555024-162080 | BECKMAN COULTER MALAYSIA SDN. BHD. NO. 18, JALAN TANDANG 51/205A, SEKSYEN 51 46050 SELANGOR 603-77728256 nbintiabdaziz@beckman.com |
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| 3 | 2025-03-19 | DxC 500 AU Clinical Chemistry Analyzer | MDA/FCA/P1231-72045130-2025 | IVDA3952124-168118 | 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 | 2025-03-19 | DxC 500i AU Chemistry Module | MDA/FCA/P1232-91158167-2025 | IVDA8913224-171351 | BECKMAN COULTER MALAYSIA SDN. BHD. NO. 18, JALAN TANDANG 51/205A, SEKSYEN 51 46050 SELANGOR 603-77728256 nbintiabdaziz@beckman.com |
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| 5 | 2025-03-17 | ABL90 FLEX | MDA/FCA/P1214-41883730-2025 | 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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| 6 | 2025-03-17 | NOVALUNG KITS | MDA/FCA/P1227-56476376-2025 | GD7111223-118844 | MEGSHER MEDIC (M) SDN BHD NO 18, JALAN TIARA 2, TIARA SQUARE, TAMAN PERINDUSTRIAN UEP, 47600 SELANGOR 603-80818440 megsher.info@gmail.com |
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| 7 | 2025-03-14 | ATELLICA® CH REVISED C‑REACTIVE PROTEIN (RCRP) | MDA/FCA/P1228-57747534-2025 | 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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| 8 | 2025-03-13 | Welch Allyn Blood Pressure Gauges | MDA/FCA/P1225-19484240-2025 | GA7214422-88069 | WELCH ALLYN MALAYSIA SDN BHD LOT NO. B-21-3A, LEVEL 21, THE ASCENT PARADIGM, NO. 1, JALAN SS7/26A, KELANA JAYA, PETALING JAYA, SELANGOR 47301 SELANGOR 603-78843341 nukun_sim@baxter.com |
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| 9 | 2025-03-12 | UPPER ARM BLOOD PRESSURE MONITOR | MDA/FCA/P1215-22764825-2025 | GB10141423-121141 | REVO HEALTHCARE SDN BHD 24, MEDAN ANGSANA 4, BANDAR BARU AIR ITAM 11500 PULAU PINANG 6012-6871289 revoliz2@gmail.com |
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| 10 | 2025-03-12 | PHADIA AB IMMUNOCAP™ SPECIFIC IGE | MDA/FCA/P1220-77969806-2025 | IVDB2215723-122106 | BIOMARKETING SERVICES (M) SDN BHD NO. 13 JALAN CEMPAKA SD 12/5, PJU 9, BANDAR SRI DAMANSARA, 52200 WILAYAH PERSEKUTUAN KUALA LUMPUR 603-62733068 rqa.my@biomedglobal.com |
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