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    <basicUdiDi>0884838BM426SY</basicUdiDi>
    <tradeName>DynaCAD</tradeName>
    <deviceName>DynaCAD</deviceName>
    <manufacturerName>Philips DS North America LLC</manufacturerName>
    <manufacturerSrn>US-MF-000035802</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050182</emdnCode>
    <emdnDescription>MMAGNETIC RESONANCE (MR) SYSTEMS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300010314352</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:11:26.238Z</lastUpdated>
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    <udiDi>+EOLEOLEASPHEREV3P00</udiDi>
    <basicUdiDi>++EOLEOLEASPHEREA3</basicUdiDi>
    <tradeName>Olea Sphere V3.0</tradeName>
    <deviceName>Olea Sphere V3.0</deviceName>
    <manufacturerName>Olea Medical S.A.S.</manufacturerName>
    <manufacturerSrn>FR-MF-000002403</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050182</emdnCode>
    <emdnDescription>MMAGNETIC RESONANCE (MR) SYSTEMS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MOD001;MOD002;MOD003;MOD004;MOD005;MOD007;MOD008;MOD010;MOD011;MOD012;MOD013;MOD014;MOD015;MOD016;MOD017;MOD020;MOD021</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:09:45.363Z</lastUpdated>
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    <udiDi>+EOLENEUROVASV1P00</udiDi>
    <basicUdiDi>++EOLENEUROVAS8M</basicUdiDi>
    <tradeName>Olea S.I.A. Neurovascular V1.0</tradeName>
    <deviceName>Olea S.I.A. Neurovascular V1.0</deviceName>
    <manufacturerName>Olea Medical S.A.S.</manufacturerName>
    <manufacturerSrn>FR-MF-000002403</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050182</emdnCode>
    <emdnDescription>MMAGNETIC RESONANCE (MR) SYSTEMS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AP-NV-FR-CT;AP-NV-FR-MR</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:09:44.559Z</lastUpdated>
  </row>
  <row>
    <udiDi>+EOLENEUROVASIV1P00</udiDi>
    <basicUdiDi>++EOLENEUROVASINSIGHTE7</basicUdiDi>
    <tradeName>Neurovascular Insight V1.0</tradeName>
    <deviceName>Neurovascular Insight V1.0</deviceName>
    <manufacturerName>Olea Medical S.A.S.</manufacturerName>
    <manufacturerSrn>FR-MF-000002403</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050182</emdnCode>
    <emdnDescription>MMAGNETIC RESONANCE (MR) SYSTEMS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AP-NVI-CT; AP-NVI-MR</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:09:43.767Z</lastUpdated>
  </row>
  <row>
    <udiDi>+EOLENEUROINSIGHTV1P00</udiDi>
    <basicUdiDi>++EOLENEUROINSIGHTPM</basicUdiDi>
    <tradeName>Neuro Insight V1.0</tradeName>
    <deviceName>Neuro Insight V1.0</deviceName>
    <manufacturerName>Olea Medical S.A.S.</manufacturerName>
    <manufacturerSrn>FR-MF-000002403</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050182</emdnCode>
    <emdnDescription>MMAGNETIC RESONANCE (MR) SYSTEMS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AP-NI-MR; AP-NI-NP-MR; AP-NI-NS-MR</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:09:43.547Z</lastUpdated>
  </row>
  <row>
    <udiDi>+EOLEMRDPMV1P00</udiDi>
    <basicUdiDi>++EOLEMRDPM96</basicUdiDi>
    <tradeName>MR Diffusion Perfusion Mismatch V1.0</tradeName>
    <deviceName>MR Diffusion Perfusion Mismatch V1.0</deviceName>
    <manufacturerName>Olea Medical S.A.S.</manufacturerName>
    <manufacturerSrn>FR-MF-000002403</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050182</emdnCode>
    <emdnDescription>MMAGNETIC RESONANCE (MR) SYSTEMS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AP-NV-DP-MR</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:09:40.805Z</lastUpdated>
  </row>
  <row>
    <udiDi>+EOLEMRDFMV1P00</udiDi>
    <basicUdiDi>++EOLEMRDFM88</basicUdiDi>
    <tradeName>MR DWI/FLAIR Measurement V1.0</tradeName>
    <deviceName>MR DWI/FLAIR Measurement V1.0</deviceName>
    <manufacturerName>Olea Medical S.A.S.</manufacturerName>
    <manufacturerSrn>FR-MF-000002403</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050182</emdnCode>
    <emdnDescription>MMAGNETIC RESONANCE (MR) SYSTEMS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AP-NV-DF-MR</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:09:40.735Z</lastUpdated>
  </row>
  <row>
    <udiDi>+EOLEFUNCTIONALMRV1P00</udiDi>
    <basicUdiDi>++EOLEFUNCTIONALMRDS</basicUdiDi>
    <tradeName>Functional MR V1.0</tradeName>
    <deviceName>Functional MR V1.0</deviceName>
    <manufacturerName>Olea Medical S.A.S.</manufacturerName>
    <manufacturerSrn>FR-MF-000002403</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050182</emdnCode>
    <emdnDescription>MMAGNETIC RESONANCE (MR) SYSTEMS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MOD030</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:09:39.622Z</lastUpdated>
  </row>
  <row>
    <udiDi>+EOLECTPERFUSIONV1P00</udiDi>
    <basicUdiDi>++EOLECTPERFUSIONDG</basicUdiDi>
    <tradeName>CT Perfusion V1.0</tradeName>
    <deviceName>CT Perfusion V1.0</deviceName>
    <manufacturerName>Olea Medical S.A.S.</manufacturerName>
    <manufacturerSrn>FR-MF-000002403</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050182</emdnCode>
    <emdnDescription>MMAGNETIC RESONANCE (MR) SYSTEMS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AP-NV-CTP</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:09:34.845Z</lastUpdated>
  </row>
  <row>
    <udiDi>+EOLEBREASTCAPEV1P00</udiDi>
    <basicUdiDi>++EOLEBREASTSCAPEYM</basicUdiDi>
    <tradeName>breastscape V1.0</tradeName>
    <deviceName>breastscape V1.0</deviceName>
    <manufacturerName>Olea Medical S.A.S.</manufacturerName>
    <manufacturerSrn>FR-MF-000002403</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050182</emdnCode>
    <emdnDescription>MMAGNETIC RESONANCE (MR) SYSTEMS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCPT001;SCPT002</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:09:30.839Z</lastUpdated>
  </row>
  <row>
    <udiDi>+EOLEAIDMV1P00</udiDi>
    <basicUdiDi>++EOLEAIDM72</basicUdiDi>
    <tradeName>AI DWI Mismatch V1.0</tradeName>
    <deviceName>AI DWI Mismatch V1.0</deviceName>
    <manufacturerName>Olea Medical S.A.S.</manufacturerName>
    <manufacturerSrn>FR-MF-000002403</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050182</emdnCode>
    <emdnDescription>MMAGNETIC RESONANCE (MR) SYSTEMS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AP-NV-AIDM-MR</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:09:30.041Z</lastUpdated>
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  <row>
    <udiDi>00884838086630</udiDi>
    <basicUdiDi>B-00884838086630</basicUdiDi>
    <tradeName>DynaCAD</tradeName>
    <deviceName>DynaCAD</deviceName>
    <manufacturerName>Invivo Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000002284</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11050182</emdnCode>
    <emdnDescription>MMAGNETIC RESONANCE (MR) SYSTEMS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>784027</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:08:11.075Z</lastUpdated>
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  <row>
    <udiDi>07340024700047</udiDi>
    <basicUdiDi>73400247S01QP</basicUdiDi>
    <tradeName>SyMRI 12</tradeName>
    <deviceName>SyMRI</deviceName>
    <manufacturerName>SyntheticMR AB</manufacturerName>
    <manufacturerSrn>SE-MF-000003513</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050182</emdnCode>
    <emdnDescription>MMAGNETIC RESONANCE (MR) SYSTEMS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0004</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:18:59.576Z</lastUpdated>
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    <udiDi>07340024700078</udiDi>
    <basicUdiDi>73400247S01QP</basicUdiDi>
    <tradeName>SyMRI 15</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SyntheticMR AB</manufacturerName>
    <manufacturerSrn>SE-MF-000003513</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050182</emdnCode>
    <emdnDescription>MMAGNETIC RESONANCE (MR) SYSTEMS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0007</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:28:31.560Z</lastUpdated>
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