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    <tradeName>CARESCAPE PDM (Patient Data Module)</tradeName>
    <deviceName>CARESCAPE PDM (Patient Data Module)</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>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020202</emdnCode>
    <emdnDescription>TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5863573</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:51:55.183Z</lastUpdated>
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    <tradeName>MLCL Client Software AltiX</tradeName>
    <deviceName>MLCL Client Software</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>
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    <emdnCode>Z12050703</emdnCode>
    <emdnDescription>POLYGRAPHY SYSTEMS FOR ELECTROPHYSIOLOGICAL STUDIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5889605</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:51:54.323Z</lastUpdated>
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    <tradeName>ComboLab AltiX</tradeName>
    <deviceName>ComboLab</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>
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    <emdnDescription>POLYGRAPHY SYSTEMS FOR ELECTROPHYSIOLOGICAL STUDIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2300000-005</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
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    <tradeName>CardioLab AltiX</tradeName>
    <deviceName>CardioLab</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>Z12050703</emdnCode>
    <emdnDescription>POLYGRAPHY SYSTEMS FOR ELECTROPHYSIOLOGICAL STUDIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2300000-004</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:51:49.617Z</lastUpdated>
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    <udiDi>00195278507037</udiDi>
    <basicUdiDi>8406821BUG00280HE</basicUdiDi>
    <tradeName>Mac-Lab AltiX</tradeName>
    <deviceName>Mac-Lab</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>Z12050702</emdnCode>
    <emdnDescription>POLYGRAPHY SYSTEMS FOR HAEMODYNAMIC STUDIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2300000-003</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:51:48.708Z</lastUpdated>
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    <udiDi>00195278503404</udiDi>
    <basicUdiDi>8406821BUG00287HU</basicUdiDi>
    <tradeName>00195278503404</tradeName>
    <deviceName>Versana Essential</deviceName>
    <manufacturerName>GE Medical Systems CO. Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001856</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>5887857</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:51:42.310Z</lastUpdated>
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    <udiDi>00195278502582</udiDi>
    <basicUdiDi>8406821BUG00405HA</basicUdiDi>
    <tradeName>OEC Elite MiniView</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>MDR 2017/745</legislation>
    <emdnCode>Z11039017</emdnCode>
    <emdnDescription>MOBILE RADIOSCOPIC UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5730328</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:51:41.530Z</lastUpdated>
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    <udiDi>00195278494542</udiDi>
    <basicUdiDi>8406821BUG00243H8</basicUdiDi>
    <tradeName>Performix Pulsar</tradeName>
    <deviceName>Performix</deviceName>
    <manufacturerName>GE Medical Systems, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000001861</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039012</emdnCode>
    <emdnDescription>X-RAY TUBE ASSEMBLY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5886600</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:51:40.701Z</lastUpdated>
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    <udiDi>00195278488473</udiDi>
    <basicUdiDi>8406821BUG00323H7</basicUdiDi>
    <tradeName>B105P Patient Monitor</tradeName>
    <deviceName>B105P Patient Monitor</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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6160000-101</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:51:36.695Z</lastUpdated>
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    <udiDi>00195278486813</udiDi>
    <basicUdiDi>8406821BUG00278HT</basicUdiDi>
    <tradeName>SIGNA Hero</tradeName>
    <deviceName>SIGNA Hero</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>Z11050105</emdnCode>
    <emdnDescription>CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD GREATER THAN 2T AND LESS THAN OR EQUAL TO 4T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SIGNA Hero</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:51:35.891Z</lastUpdated>
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    <udiDi>00195278490742</udiDi>
    <basicUdiDi>8406821BUG00329HK</basicUdiDi>
    <tradeName>VSP 4.0 Upgrade Software</tradeName>
    <deviceName>VSP 4.0 Upgrade Software</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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020282</emdnCode>
    <emdnDescription>MULTI-PARAMETER MONITORS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5877259</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:51:35.108Z</lastUpdated>
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    <udiDi>00195278488619</udiDi>
    <basicUdiDi>8406821BUG00251H7</basicUdiDi>
    <tradeName>MyoSPECT</tradeName>
    <deviceName>MyoSPECT</deviceName>
    <manufacturerName>GE Medical Systems Israel, Functional Imaging</manufacturerName>
    <manufacturerSrn>IL-MF-000003062</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11020104</emdnCode>
    <emdnDescription>FIXED STATION GAMMA CAMERAS WITH MULTIPLE HEADS - WITHOUT ‘TOTAL BODY’ ACQUISITION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H3912BC</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:51:34.390Z</lastUpdated>
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    <udiDi>00195278483713</udiDi>
    <basicUdiDi>8406821BUG00299J3</basicUdiDi>
    <tradeName>SIGNA 7.0T</tradeName>
    <deviceName>SIGNA 7.0T</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>Z11050106</emdnCode>
    <emdnDescription>CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD GREATER THAN 4T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SIGNA 7.0T</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:51:17.443Z</lastUpdated>
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    <udiDi>00195278481382</udiDi>
    <basicUdiDi>8406821BUG00286HS</basicUdiDi>
    <tradeName>SIGNA Artist Evo</tradeName>
    <deviceName>SIGNA Artist Evo</deviceName>
    <manufacturerName>GE Healthcare Tianjin Company Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000001725</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>SIGNA Artist Evo</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:51:16.633Z</lastUpdated>
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    <udiDi>00195278466471</udiDi>
    <basicUdiDi>8406821BUG00296HV</basicUdiDi>
    <tradeName>00195278466471</tradeName>
    <deviceName>L4-20t-D</deviceName>
    <manufacturerName>GE Medical Systems CO. Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001856</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110402010101</emdnCode>
    <emdnDescription>TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5874154</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:51:15.846Z</lastUpdated>
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    <udiDi>00195278458070</udiDi>
    <basicUdiDi>8406821BUG00305H5</basicUdiDi>
    <tradeName>MUSE NX</tradeName>
    <deviceName>MUSE NX Cardiology Information System</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>Z12050392</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4101010-002</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:51:10.259Z</lastUpdated>
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    <udiDi>00195278457547</udiDi>
    <basicUdiDi>8406821BUG00415HD</basicUdiDi>
    <tradeName>EK12</tradeName>
    <deviceName>EK12</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>Z12050392</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2104498-003</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:51:09.443Z</lastUpdated>
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    <basicUdiDi>8406821BUG00292HM</basicUdiDi>
    <tradeName>KISS+</tradeName>
    <deviceName>KISS+ EEAS</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>2093551-100</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:51:08.648Z</lastUpdated>
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    <basicUdiDi>8406821BUG00403H6</basicUdiDi>
    <tradeName>Carestation 650 A1</tradeName>
    <deviceName>Anesthesia System</deviceName>
    <manufacturerName>Datex-Ohmeda Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014656</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010101</emdnCode>
    <emdnDescription>ANAESTHESIA DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1012-9650-200</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:51:04.634Z</lastUpdated>
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    <udiDi>00195278422279</udiDi>
    <basicUdiDi>8406821BUG00255HF</basicUdiDi>
    <tradeName>00195278422279</tradeName>
    <deviceName>Vivid T8,Vivid T9</deviceName>
    <manufacturerName>GE Medical Systems CO. Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001856</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040102</emdnCode>
    <emdnDescription>CARDIOLOGY ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Vivid T9 v206/5876948</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:51:03.826Z</lastUpdated>
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