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<eudamedExport entity="devices">
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    <basicUdiDi>059998880519KNAIEY</basicUdiDi>
    <tradeName>KNAI</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthopred Ltd</manufacturerName>
    <manufacturerSrn>HU-MF-000022429</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11059092</emdnCode>
    <emdnDescription>VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>KNAI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:42:23.208Z</lastUpdated>
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    <udiDi>04068151086584</udiDi>
    <basicUdiDi>0405686902283VR</basicUdiDi>
    <tradeName>LungMaps</tradeName>
    <deviceName>MDR_02_IIa_FOR AG S3_ACDV_SaMD</deviceName>
    <manufacturerName>Siemens Healthineers AG</manufacturerName>
    <manufacturerSrn>DE-MF-000038456</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050192</emdnCode>
    <emdnDescription>MAGNETIC RESONANCE (MR) SYSTEMS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VA10A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:39:32.397Z</lastUpdated>
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    <udiDi>04056869997094</udiDi>
    <basicUdiDi>0405686902279W2</basicUdiDi>
    <tradeName>MAGNETOM Free.XL</tradeName>
    <deviceName>MDR_02_IIa_FOR AG S3_ACDV_Magnetom</deviceName>
    <manufacturerName>Siemens Healthineers AG</manufacturerName>
    <manufacturerSrn>DE-MF-000038456</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>11690226</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:39:11.754Z</lastUpdated>
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    <udiDi>04056869964386</udiDi>
    <basicUdiDi>0405686900128UW</basicUdiDi>
    <tradeName>Chondral Quant</tradeName>
    <deviceName>MDR_02_IIa_ERLN H 127_ACDV_SaMD</deviceName>
    <manufacturerName>Siemens Healthcare GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006122</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050192</emdnCode>
    <emdnDescription>MAGNETIC RESONANCE (MR) SYSTEMS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VA10A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:10:56.751Z</lastUpdated>
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  <row>
    <udiDi>04056869265841</udiDi>
    <basicUdiDi>0405686900131UK</basicUdiDi>
    <tradeName>MAGNETOM Amira</tradeName>
    <deviceName>MDR_02_SPPP_IIa_SZN G MR_Comb.Magnetom</deviceName>
    <manufacturerName>Siemens Shenzhen Magnetic Resonance Ltd.</manufacturerName>
    <manufacturerSrn>CN-PR-000020467</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>11568941</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:10:44.780Z</lastUpdated>
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  <row>
    <udiDi>04056869006819</udiDi>
    <basicUdiDi>0405686900126US</basicUdiDi>
    <tradeName>MAGNETOM Amira</tradeName>
    <deviceName>MDR_02_IIa_SZN G MR ERL H 127_ACDV_Magnetom</deviceName>
    <manufacturerName>Siemens Shenzhen Magnetic Resonance Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013436</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011241</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>10836777</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:10:30.346Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056869006697</udiDi>
    <basicUdiDi>0405686900125UQ</basicUdiDi>
    <tradeName>MAGNETOM Aera</tradeName>
    <deviceName>MDR_02_IIa_ERLN H 127_ACDV_Magnetom</deviceName>
    <manufacturerName>Siemens Healthcare GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006122</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>10432914</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:10:23.700Z</lastUpdated>
  </row>
  <row>
    <udiDi>00859193006210</udiDi>
    <basicUdiDi>0085919300588SI150122</basicUdiDi>
    <tradeName>PROCURE</tradeName>
    <deviceName>PROCURE 1.5T Siemens</deviceName>
    <manufacturerName>ScanMed LLC</manufacturerName>
    <manufacturerSrn>US-MF-000011107</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11059080</emdnCode>
    <emdnDescription>VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>588SI1501</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:38:49.644Z</lastUpdated>
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  <row>
    <udiDi>00859193006005</udiDi>
    <basicUdiDi>0085919300588SI3001ZL</basicUdiDi>
    <tradeName>PROCURE</tradeName>
    <deviceName>PROCURE 3T Siemens</deviceName>
    <manufacturerName>ScanMed LLC</manufacturerName>
    <manufacturerSrn>US-MF-000011107</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11059080</emdnCode>
    <emdnDescription>VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>588SI3001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:38:45.831Z</lastUpdated>
  </row>
  <row>
    <udiDi>G408INBOREMRISYSTEM0</udiDi>
    <basicUdiDi>++G408INBORE01LEDMRIGF</basicUdiDi>
    <tradeName>Kryptonite Solutions</tradeName>
    <deviceName>In-Bore MRI cinema</deviceName>
    <manufacturerName>Kryptonite Solutions</manufacturerName>
    <manufacturerSrn>IN-MF-000032766</manufacturerSrn>
    <authorisedRepresentativeName>Mars Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006312</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>KIBM101</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T17:42:07.768Z</lastUpdated>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
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