<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00195278822383</udiDi>
    <basicUdiDi>B-00195278822383</basicUdiDi>
    <tradeName>Xeleris V Processing &amp; Review System</tradeName>
    <deviceName>Xeleris V Processing and Review System</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>MDD</legislation>
    <emdnCode>Z11069092</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5955981</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:07:49.582Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278118295</udiDi>
    <basicUdiDi>B-00195278118295</basicUdiDi>
    <tradeName>StarGuide</tradeName>
    <deviceName>StarGuide</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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11020201</emdnCode>
    <emdnDescription>CT/GAMMA CAMERA SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H3911AA</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:07:34.369Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278011343</udiDi>
    <basicUdiDi>B-00195278011343</basicUdiDi>
    <tradeName>DaTQUANT</tradeName>
    <deviceName>DaTQUANT</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>MDD</legislation>
    <emdnCode>Z11069092</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H3901ZD</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:07:28.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278788269</udiDi>
    <basicUdiDi>8406821BUG00401H2</basicUdiDi>
    <tradeName>NM/CT 870 DR</tradeName>
    <deviceName>NM/CT 870 DR</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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11020201</emdnCode>
    <emdnDescription>CT/GAMMA CAMERA SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H3906FZ, H3906GA, H3906GB, H3906GC, H3906GD, H3906GE</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:53:43.291Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278788252</udiDi>
    <basicUdiDi>8406821BUG00402H4</basicUdiDi>
    <tradeName>NM 830</tradeName>
    <deviceName>NM 830</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>Z11020105</emdnCode>
    <emdnDescription>FIXED STATION GAMMA CAMERAS WITH MULTIPLE HEADS - WITH ‘TOTAL BODY’ ACQUISITION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H3910AY, H3910AZ and H3910BA</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:53:40.888Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278755544</udiDi>
    <basicUdiDi>8406821BUG00422HA</basicUdiDi>
    <tradeName>00195278755544</tradeName>
    <deviceName>StarGuide</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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11020201</emdnCode>
    <emdnDescription>CT/GAMMA CAMERA SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H3911BH</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:53:36.992Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278614933</udiDi>
    <basicUdiDi>8406821BUG00344HF</basicUdiDi>
    <tradeName>Xeleris V Processing &amp; Review System</tradeName>
    <deviceName>Xeleris V Processing and Review System</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>Z11069092</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5927911</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:52:38.941Z</lastUpdated>
  </row>
  <row>
    <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>
  </row>
  <row>
    <udiDi>00840682159463</udiDi>
    <basicUdiDi>8406821BUG00007GS</basicUdiDi>
    <tradeName>NM/CT 870 CZT</tradeName>
    <deviceName>NM/CT 870 CZT</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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11020201</emdnCode>
    <emdnDescription>CT/GAMMA CAMERA SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H3906EX , H3906EW</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:47:26.581Z</lastUpdated>
  </row>
  <row>
    <udiDi>00198953006849</udiDi>
    <basicUdiDi>08406821BUG005727J</basicUdiDi>
    <tradeName>Omni</tradeName>
    <deviceName></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 IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCM-PET0014</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:35:10.469Z</lastUpdated>
  </row>
  <row>
    <udiDi>00198953061329</udiDi>
    <basicUdiDi>08406821BUG004717B</basicUdiDi>
    <tradeName>NM/CT 860</tradeName>
    <deviceName></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 IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CT/GAMMA CAMERA SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H3908BF, H3908BG, H3908BK, H3908BL, H3908BM, H3908BN</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:34:49.579Z</lastUpdated>
  </row>
  <row>
    <udiDi>00198953061336</udiDi>
    <basicUdiDi>08406821BUG004697Q</basicUdiDi>
    <tradeName>NM/CT 850</tradeName>
    <deviceName></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 IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CT/GAMMA CAMERA SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H3907BC, H3907BD, H3907BH, H3907BJ, H3907BG, H3907BK</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:34:49.563Z</lastUpdated>
  </row>
  <row>
    <udiDi>00198953125540</udiDi>
    <basicUdiDi>08406821BUG0062278</basicUdiDi>
    <tradeName>StarGuide GX</tradeName>
    <deviceName></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 IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CT/GAMMA CAMERA SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H3911BW</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:34:49.087Z</lastUpdated>
  </row>
  <row>
    <udiDi>00198953147122</udiDi>
    <basicUdiDi>08406821BUG0062278</basicUdiDi>
    <tradeName>StarGuide to StarGuide with dsCZT Detectors</tradeName>
    <deviceName></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 IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CT/GAMMA CAMERA SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H3911CF</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:34:46.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840682134897</udiDi>
    <basicUdiDi>B-00840682134897</basicUdiDi>
    <tradeName>Xeleris 4 DR Processing &amp; Review Workstation</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5782764</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:04:12.958Z</lastUpdated>
  </row>
  <row>
    <udiDi>00198953180099</udiDi>
    <basicUdiDi>08406821BUG005727J</basicUdiDi>
    <tradeName>Omni</tradeName>
    <deviceName></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 IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCM-PET0014</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T21:05:02.023Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IL-MF-000003062WY</udiDi>
    <basicUdiDi>B-IL-MF-000003062WY</basicUdiDi>
    <tradeName>MyoSPECT</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H3912AA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:59:46.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278878502</udiDi>
    <basicUdiDi>08406821BUG004817E</basicUdiDi>
    <tradeName>Aurora</tradeName>
    <deviceName></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 IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-05T17:04:23.113Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278870490</udiDi>
    <basicUdiDi>8406821BUG00422HA</basicUdiDi>
    <tradeName>StarGuide MDD to MDR Upgrade</tradeName>
    <deviceName></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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11020201</emdnCode>
    <emdnDescription>CT/GAMMA CAMERA SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-02T14:39:45.290Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278722546</udiDi>
    <basicUdiDi>8406821BUG00251H7</basicUdiDi>
    <tradeName>MyoSPECT ES to MyoSPECT Upgrade</tradeName>
    <deviceName></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></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-02T14:39:16.426Z</lastUpdated>
  </row>
</eudamedExport>