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    <basicUdiDi>0616258TFCN-0101I2P</basicUdiDi>
    <tradeName>MEDRAD® Avanta Fluid Management System Disposables</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bayer Medical Care Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007050</manufacturerSrn>
    <authorisedRepresentativeName>Bayer Medical Care B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000240</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVA 500 HCS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:51.880Z</lastUpdated>
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  <row>
    <udiDi>00616258024974</udiDi>
    <basicUdiDi>0616258TFCN-0090QH</basicUdiDi>
    <tradeName>MEDRAD® MRXperion MR Injection System Syringe Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bayer Medical Care Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007050</manufacturerSrn>
    <authorisedRepresentativeName>Bayer Medical Care B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000240</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XP 115VS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:51.862Z</lastUpdated>
  </row>
  <row>
    <udiDi>00616258024998</udiDi>
    <basicUdiDi>0616258TFCN-0048QJ</basicUdiDi>
    <tradeName>MEDRAD® Spectris Solaris Sterile Disposables System Syringe Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bayer Medical Care Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007050</manufacturerSrn>
    <authorisedRepresentativeName>Bayer Medical Care B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000240</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LOW PRESSURE EXTENSION LINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FFA 50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:51.842Z</lastUpdated>
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    <udiDi>00616258025094</udiDi>
    <basicUdiDi>0616258TFCN-0089IIb2P</basicUdiDi>
    <tradeName>MEDRAD® MRXperion MR Injection System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bayer Medical Care Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007050</manufacturerSrn>
    <authorisedRepresentativeName>Bayer Medical Care B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000240</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MAGNETIC RESONANCE INJECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MRXP 200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:51.824Z</lastUpdated>
  </row>
  <row>
    <udiDi>00616258025131</udiDi>
    <basicUdiDi>0616258TFCN-0082IIbZ3</basicUdiDi>
    <tradeName>MEDRAD® Stellant CT Injection System with Certegra Workstation</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bayer Medical Care Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007050</manufacturerSrn>
    <authorisedRepresentativeName>Bayer Medical Care B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000240</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ANGIOGRAPHIC INJECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCT-310</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:51.805Z</lastUpdated>
  </row>
  <row>
    <udiDi>00616258025186</udiDi>
    <basicUdiDi>0616258TFCN-0082IIbZ3</basicUdiDi>
    <tradeName>MEDRAD® Stellant CT Injection System with Certegra Workstation</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bayer Medical Care Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007050</manufacturerSrn>
    <authorisedRepresentativeName>Bayer Medical Care B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000240</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ANGIOGRAPHIC INJECTORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>SCT-310</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:51.781Z</lastUpdated>
  </row>
  <row>
    <udiDi>00616258025193</udiDi>
    <basicUdiDi>0616258TFCN-0060Q8</basicUdiDi>
    <tradeName>MEDRAD® Avanta Fluid Management Injection System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bayer Medical Care Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007050</manufacturerSrn>
    <authorisedRepresentativeName>Bayer Medical Care B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000240</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ANGIOGRAPHIC INJECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVA 500 TABL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:51.754Z</lastUpdated>
  </row>
  <row>
    <udiDi>00616258025209</udiDi>
    <basicUdiDi>0616258TFCN-0060Q8</basicUdiDi>
    <tradeName>MEDRAD® Avanta Fluid Management Injection System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bayer Medical Care Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007050</manufacturerSrn>
    <authorisedRepresentativeName>Bayer Medical Care B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000240</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ANGIOGRAPHIC INJECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVA 500 PEDL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:51.729Z</lastUpdated>
  </row>
  <row>
    <udiDi>00616258025247</udiDi>
    <basicUdiDi>0616258TFCN-0060I3B</basicUdiDi>
    <tradeName>MEDRAD® Avanta Fluid Management Injection System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bayer Medical Care Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007050</manufacturerSrn>
    <authorisedRepresentativeName>Bayer Medical Care B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000240</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>FLUIDS HEATING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVA 500 SYRH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:51.700Z</lastUpdated>
  </row>
  <row>
    <udiDi>00616258025254</udiDi>
    <basicUdiDi>0616258TFCN-0060I3B</basicUdiDi>
    <tradeName>MEDRAD® Avanta Fluid Management Injection System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bayer Medical Care Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007050</manufacturerSrn>
    <authorisedRepresentativeName>Bayer Medical Care B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000240</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>FLUIDS HEATING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVA 500 BTLH-M</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:51.673Z</lastUpdated>
  </row>
  <row>
    <udiDi>00616258025308</udiDi>
    <basicUdiDi>0616258TFCN-0081IIbYU</basicUdiDi>
    <tradeName>MEDRAD® Mark 7 Arterion Injection System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bayer Medical Care Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007050</manufacturerSrn>
    <authorisedRepresentativeName>Bayer Medical Care B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000240</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CONTROLLERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ART 700 FS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:51.640Z</lastUpdated>
  </row>
  <row>
    <udiDi>00616258025315</udiDi>
    <basicUdiDi>0616258TFCN-0081IIbYU</basicUdiDi>
    <tradeName>MEDRAD® Mark 7 Arterion Injection System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bayer Medical Care Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007050</manufacturerSrn>
    <authorisedRepresentativeName>Bayer Medical Care B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000240</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CONTROLLERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ART 700 HS6</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:51.613Z</lastUpdated>
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  <row>
    <udiDi>00616258025322</udiDi>
    <basicUdiDi>0616258TFCN-0081IIbYU</basicUdiDi>
    <tradeName>MEDRAD® Mark 7 Arterion Injection System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bayer Medical Care Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007050</manufacturerSrn>
    <authorisedRepresentativeName>Bayer Medical Care B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000240</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CONTROLLERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ART 700 HS12</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:51.594Z</lastUpdated>
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  <row>
    <udiDi>00616258025339</udiDi>
    <basicUdiDi>0616258TFCN-0081IIbYU</basicUdiDi>
    <tradeName>MEDRAD® Mark 7 Arterion Injection System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bayer Medical Care Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007050</manufacturerSrn>
    <authorisedRepresentativeName>Bayer Medical Care B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000240</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>FLUIDS HEATING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ART 700 HM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:51.580Z</lastUpdated>
  </row>
  <row>
    <udiDi>00616258025353</udiDi>
    <basicUdiDi>0616258TFCN-0060I3B</basicUdiDi>
    <tradeName>MEDRAD® Avanta Fluid Management Injection System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bayer Medical Care Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007050</manufacturerSrn>
    <authorisedRepresentativeName>Bayer Medical Care B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000240</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>FLUIDS HEATING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVA 500 BTLH-L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:51.563Z</lastUpdated>
  </row>
  <row>
    <udiDi>00616258025377</udiDi>
    <basicUdiDi>0616258TFCN-0082I3T</basicUdiDi>
    <tradeName>MEDRAD® Stellant CT Injection System with Certegra Workstation</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bayer Medical Care Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007050</manufacturerSrn>
    <authorisedRepresentativeName>Bayer Medical Care B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000240</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CONTROLLERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SHS 700 05</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:51.547Z</lastUpdated>
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  <row>
    <udiDi>00616258025384</udiDi>
    <basicUdiDi>0616258TFCN-0082I3T</basicUdiDi>
    <tradeName>MEDRAD® Stellant CT Injection System with Certegra Workstation</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bayer Medical Care Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007050</manufacturerSrn>
    <authorisedRepresentativeName>Bayer Medical Care B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000240</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>FLUIDS HEATING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SSH 200F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:51.536Z</lastUpdated>
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    <udiDi>00616258025773</udiDi>
    <basicUdiDi>0616258TFCN-0060I3B</basicUdiDi>
    <tradeName>MEDRAD® Avanta Fluid Management Injection System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bayer Medical Care Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007050</manufacturerSrn>
    <authorisedRepresentativeName>Bayer Medical Care B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000240</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CONTROLLERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVA 500 FTC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:51.524Z</lastUpdated>
  </row>
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    <udiDi>00616258025827</udiDi>
    <basicUdiDi>0616258TFCN-0107IIaXR</basicUdiDi>
    <tradeName>MEDRAD® MRXperion 250 cm Single Patient Disposable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bayer Medical Care Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007050</manufacturerSrn>
    <authorisedRepresentativeName>Bayer Medical Care B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000240</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LOW PRESSURE EXTENSION LINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XP SP</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:51.509Z</lastUpdated>
  </row>
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    <udiDi>00616258025971</udiDi>
    <basicUdiDi>0616258TFCN-0107IIaXR</basicUdiDi>
    <tradeName>MEDRAD® MRXperion Multi-Patient Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bayer Medical Care Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007050</manufacturerSrn>
    <authorisedRepresentativeName>Bayer Medical Care B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000240</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>REUSABLE SYRINGES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XP MP</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:51.489Z</lastUpdated>
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