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    <basicUdiDi>8406821BUG00216H5</basicUdiDi>
    <tradeName>Universal Viewer 8.1</tradeName>
    <deviceName>Universal Viewer</deviceName>
    <manufacturerName>GE Healthcare</manufacturerName>
    <manufacturerSrn>US-MF-000001862</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5865733-001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:43:18.990Z</lastUpdated>
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    <udiDi>00195278516480</udiDi>
    <basicUdiDi>8406821BUG00053GZ</basicUdiDi>
    <tradeName>Venue</tradeName>
    <deviceName>Venue</deviceName>
    <manufacturerName>GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000016119</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040101</emdnCode>
    <emdnDescription>INTERNAL ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Venue R4</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:43:12.677Z</lastUpdated>
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    <udiDi>00195278473028</udiDi>
    <basicUdiDi>8406821BUG00209H8</basicUdiDi>
    <tradeName>00195278473028</tradeName>
    <deviceName>Voluson S10 Expert, Voluson S10, Voluson S8t, Voluson S8, Voluson S6</deviceName>
    <manufacturerName>GE Ultrasound Korea, Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000001860</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040101</emdnCode>
    <emdnDescription>INTERNAL ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Voluson Signature to BT22 UPG / 5881172</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:43:06.192Z</lastUpdated>
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    <udiDi>00195278473011</udiDi>
    <basicUdiDi>8406821BUG00210GR</basicUdiDi>
    <tradeName>00195278473011</tradeName>
    <deviceName>Voluson P8, Voluson P6</deviceName>
    <manufacturerName>GE Ultrasound Korea, Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000001860</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040101</emdnCode>
    <emdnDescription>INTERNAL ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Voluson Performance to BT22 UPG / 5881175</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:43:05.383Z</lastUpdated>
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    <udiDi>00195278471277</udiDi>
    <basicUdiDi>8406821BUG00154H8</basicUdiDi>
    <tradeName>Revolution CT ES with Apex edition</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GE Medical Systems, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000018315</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030607</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 256 LAYERS OR MORE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Revolution CT ES with Apex edition</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:43:03.792Z</lastUpdated>
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    <udiDi>00195278469700</udiDi>
    <basicUdiDi>8406821BUG00213GX</basicUdiDi>
    <tradeName>Revolution Apex Select</tradeName>
    <deviceName>Revolution Apex Select</deviceName>
    <manufacturerName>GE HANGWEI MEDICAL SYSTEMS CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009292</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030606</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Power Xtream: B7919QT; Power Pro: B7919QS</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:43:01.470Z</lastUpdated>
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    <udiDi>00195278466488</udiDi>
    <basicUdiDi>8406821BUG00215H3</basicUdiDi>
    <tradeName>RT Refresh Package</tradeName>
    <deviceName>RT Refresh Package</deviceName>
    <manufacturerName>GE HANGWEI MEDICAL SYSTEMS CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009292</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030603</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 16 LAYERS OR MORE BUT LESS THAN 64 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B79612DA, B79602DA</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:42:58.978Z</lastUpdated>
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    <udiDi>00195278464613</udiDi>
    <basicUdiDi>8406821BUG00211GT</basicUdiDi>
    <tradeName>00195278464613</tradeName>
    <deviceName>LOGIQ P8, LOGIQ P9, LOGIQ P10</deviceName>
    <manufacturerName>GE Ultrasound Korea, Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000001860</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040101</emdnCode>
    <emdnDescription>INTERNAL ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LOGIQ P8 R4.5/H42932LB</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:42:58.193Z</lastUpdated>
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  <row>
    <udiDi>00195278460271</udiDi>
    <basicUdiDi>8406821BUG00014GP</basicUdiDi>
    <tradeName>Revolution Apex Elite</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GE Medical Systems, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000018315</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030607</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 256 LAYERS OR MORE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5590000-23</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:42:54.182Z</lastUpdated>
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  <row>
    <udiDi>00195278454218</udiDi>
    <basicUdiDi>8406821BUG00208H6</basicUdiDi>
    <tradeName>Omni Legend</tradeName>
    <deviceName>Omni Legend</deviceName>
    <manufacturerName>GE Medical Systems, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000018315</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11020301</emdnCode>
    <emdnDescription>CT/PET SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCM-PET0012</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:42:52.571Z</lastUpdated>
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    <udiDi>00195278421449</udiDi>
    <basicUdiDi>8406821BUG00183HF</basicUdiDi>
    <tradeName>00195278421449</tradeName>
    <deviceName>CAM-14</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 IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>900995-102</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:42:51.781Z</lastUpdated>
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    <udiDi>00195278416339</udiDi>
    <basicUdiDi>8406821BUG00105GT</basicUdiDi>
    <tradeName>1.5T HDxt Upgrade Kit</tradeName>
    <deviceName>1.5T HDxt Upgrade Kit</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 IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050104</emdnCode>
    <emdnDescription>CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1.5T HDxt Upgrade Kit</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:42:50.266Z</lastUpdated>
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    <udiDi>00195278410221</udiDi>
    <basicUdiDi>8406821BUG00033GT</basicUdiDi>
    <tradeName>00195278410221</tradeName>
    <deviceName>LOGIQ E10s</deviceName>
    <manufacturerName>GE Ultrasound Korea, Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000001860</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040101</emdnCode>
    <emdnDescription>INTERNAL ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5860223</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:42:46.975Z</lastUpdated>
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    <udiDi>00195278409287</udiDi>
    <basicUdiDi>8406821BUG00019GZ</basicUdiDi>
    <tradeName>Enterprise Archive v8</tradeName>
    <deviceName>Centricity Enterprise Archive / Enterprise Archive</deviceName>
    <manufacturerName>GE Healthcare</manufacturerName>
    <manufacturerSrn>US-MF-000001862</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030592</emdnCode>
    <emdnDescription>RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5865732</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:42:45.381Z</lastUpdated>
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    <udiDi>00195278405326</udiDi>
    <basicUdiDi>8406821BUG00214GZ</basicUdiDi>
    <tradeName>00195278405326</tradeName>
    <deviceName>LOGIQ Fortis</deviceName>
    <manufacturerName>GE Ultrasound Korea, Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000001860</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040101</emdnCode>
    <emdnDescription>INTERNAL ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6602000</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:42:44.584Z</lastUpdated>
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    <udiDi>00195278403643</udiDi>
    <basicUdiDi>8406821BUG00170H6</basicUdiDi>
    <tradeName>CASE</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 IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2035123-001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:42:42.970Z</lastUpdated>
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    <udiDi>00195278384041</udiDi>
    <basicUdiDi>8406821BUG00028H2</basicUdiDi>
    <tradeName>LOGIQ E10</tradeName>
    <deviceName>LOGIQ E10</deviceName>
    <manufacturerName>GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000016119</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040104</emdnCode>
    <emdnDescription>MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5935000E10-3</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:42:40.564Z</lastUpdated>
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    <udiDi>00195278363947</udiDi>
    <basicUdiDi>8406821BUG00175HG</basicUdiDi>
    <tradeName>00195278363947</tradeName>
    <deviceName>MaxFOV 2</deviceName>
    <manufacturerName>GE HANGWEI MEDICAL SYSTEMS CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009292</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030692</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MaxFOV 2</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:42:39.303Z</lastUpdated>
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    <udiDi>00195278362230</udiDi>
    <basicUdiDi>8406821BUG00202GS</basicUdiDi>
    <tradeName>Revolution Frontier</tradeName>
    <deviceName>Revolution Frontier Gen 3_HD Refresh Package</deviceName>
    <manufacturerName>GE HANGWEI MEDICAL SYSTEMS CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009292</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030605</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 64 LAYERS OR MORE BUT LESS THAN 128 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Revolution Frontier</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:42:38.263Z</lastUpdated>
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    <udiDi>00195278364661</udiDi>
    <basicUdiDi>8406821BUG00157HE</basicUdiDi>
    <tradeName>Cardiosoft</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 IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2032557-001, 2032558-001, 2032559-001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:42:36.013Z</lastUpdated>
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