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    <manufacturerName>GE Medical Systems, LLC</manufacturerName>
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    <emdnDescription>X-RAY TUBE ASSEMBLY</emdnDescription>
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    <lastUpdated>2026-06-22T06:04:13.015Z</lastUpdated>
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    <tradeName>Xeleris 4 DR Processing &amp; Review Workstation</tradeName>
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    <manufacturerName>GE Medical Systems Israel, Functional Imaging</manufacturerName>
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    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
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    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
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    <udiDi>00840682134934</udiDi>
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    <tradeName>Y-ADAPTOR 1 TB BARB MALE 1/8 TO 2 TB NEO-SNAP MALE, SINGLE</tradeName>
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    <manufacturerName>GE Medical Systems Information Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017529</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
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    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>AIR Posterior Array</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GE Healthcare Coils</manufacturerName>
    <manufacturerSrn>US-MF-000001664</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1105018001</emdnCode>
    <emdnDescription>MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5999959</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:04:12.448Z</lastUpdated>
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    <basicUdiDi>8406821BUG00121GR</basicUdiDi>
    <tradeName>NICU ECG LEADWIRE SET</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GE Medical Systems Information Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017529</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050380</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2080557-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:04:11.987Z</lastUpdated>
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    <udiDi>00840682138031</udiDi>
    <basicUdiDi>8406821BUG00121GR</basicUdiDi>
    <tradeName>NICU ECG LEADWIRE SET</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GE Medical Systems Information Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017529</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050380</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2080557-004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:04:11.961Z</lastUpdated>
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    <basicUdiDi>8406821BUG00121GR</basicUdiDi>
    <tradeName>NICU ECG LEADWIRE SET</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GE Medical Systems Information Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017529</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050380</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2080557-003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:04:11.925Z</lastUpdated>
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    <basicUdiDi>8406821BUG00121GR</basicUdiDi>
    <tradeName>NICU ECG LEADWIRE SET</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GE Medical Systems Information Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017529</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050380</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2080557-002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:04:11.896Z</lastUpdated>
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    <tradeName>Discovery XR656 HD</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GE HUALUN MEDICAL SYSTEMS CO. Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001189</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Discovery XR656 HD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:04:11.776Z</lastUpdated>
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    <udiDi>00840682138611</udiDi>
    <basicUdiDi>8406821BUG00310GW</basicUdiDi>
    <tradeName>AIR Anterior Array</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GE Healthcare Coils</manufacturerName>
    <manufacturerSrn>US-MF-000001664</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1105018001</emdnCode>
    <emdnDescription>MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5746694</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:04:11.744Z</lastUpdated>
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    <udiDi>00840682139205</udiDi>
    <basicUdiDi>8406821BUG00151H2</basicUdiDi>
    <tradeName>Dielectric Pad - Abdomen</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GE Medical Systems LLC</manufacturerName>
    <manufacturerSrn>US-MF-000001632</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1105018099</emdnCode>
    <emdnDescription>MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5790189-2 (E8823JE, E8823JF)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:04:11.607Z</lastUpdated>
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    <basicUdiDi>B-00840682142113</basicUdiDi>
    <tradeName>NM 830</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GE HUALUN MEDICAL SYSTEMS CO. Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001189</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>FIXED STATION GAMMA CAMERAS WITH MULTIPLE HEADS - WITH ‘TOTAL BODY’ ACQUISITION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5797112 PCM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:04:09.362Z</lastUpdated>
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    <tradeName>NM/CT 870 DR</tradeName>
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    <manufacturerName>GE HUALUN MEDICAL SYSTEMS CO. Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001189</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CT/GAMMA CAMERA SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5797111</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:04:09.341Z</lastUpdated>
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    <basicUdiDi>B-00840682142137</basicUdiDi>
    <tradeName>NM/CT 860</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GE HUALUN MEDICAL SYSTEMS CO. Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001189</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CT/GAMMA CAMERA SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5804395 PCM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:04:09.320Z</lastUpdated>
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    <manufacturerName>GE HUALUN MEDICAL SYSTEMS CO. Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001189</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CT/GAMMA CAMERA SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5804394 PCM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:04:09.296Z</lastUpdated>
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    <tradeName>Optima XR646 HD</tradeName>
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    <manufacturerName>GE HUALUN MEDICAL SYSTEMS CO. Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001189</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Optima XR646 HD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:04:09.272Z</lastUpdated>
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    <tradeName>TOCO TRANSDUCER WATERTIGHT BUTTON AND LOOP</tradeName>
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    <manufacturerName>Wipro GE Healthcare Private Ltd</manufacturerName>
    <manufacturerSrn>IN-MF-000016100</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1208010403</emdnCode>
    <emdnDescription>TRANSMITTING UNITS FOR CARDIOTOCOGRAPHIC TELEMETRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2108347-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:04:09.219Z</lastUpdated>
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    <tradeName>SnapShot Freeze 2</tradeName>
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    <manufacturerName>GE Medical Systems, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000018315</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5807631</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:04:09.206Z</lastUpdated>
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    <tradeName>Lullaby Resus Plus – NIST</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Datex-Ohmeda Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002206</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080499</emdnCode>
    <emdnDescription>NEONATOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2070100-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:04:09.117Z</lastUpdated>
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    <tradeName>Lullaby Warmer - WARMER MAIN ASM, 115V for sea shipment</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Datex-Ohmeda Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002206</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080407</emdnCode>
    <emdnDescription>NEONATAL RADIANT WARMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2061755-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:04:09.099Z</lastUpdated>
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