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<eudamedExport entity="devices">
  <row>
    <udiDi>00616258024486</udiDi>
    <basicUdiDi>0616258TFCN-0002PS</basicUdiDi>
    <tradeName>MRI Integral “T” with Check Valve for MEDRAD® Spectris MR Injector</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>SIT 96V</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:52.262Z</lastUpdated>
  </row>
  <row>
    <udiDi>00616258024516</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>SSIT 96VLD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:52.244Z</lastUpdated>
  </row>
  <row>
    <udiDi>00616258024523</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>SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SSQK 115</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:52.226Z</lastUpdated>
  </row>
  <row>
    <udiDi>00616258024530</udiDi>
    <basicUdiDi>0616258TFCN-0050Q5</basicUdiDi>
    <tradeName>MEDRAD® Stellant Syringe Kits</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>SSS-LP-60</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:52.201Z</lastUpdated>
  </row>
  <row>
    <udiDi>00616258024547</udiDi>
    <basicUdiDi>0616258TFCN-0050Q5</basicUdiDi>
    <tradeName>MEDRAD® Stellant Syringe Kits</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>SSS-LP-60-T</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:52.183Z</lastUpdated>
  </row>
  <row>
    <udiDi>00616258024554</udiDi>
    <basicUdiDi>0616258TFCN-0054QD</basicUdiDi>
    <tradeName>Swabbable Valve Transfer Set</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 - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SVTS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:52.169Z</lastUpdated>
  </row>
  <row>
    <udiDi>00616258024561</udiDi>
    <basicUdiDi>0616258TFCN-0086QS</basicUdiDi>
    <tradeName>MEDRAD® Twist &amp; Go Disposable Syringe 150 mL with Quick Fill Tube</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>TAG 150 SYR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:52.153Z</lastUpdated>
  </row>
  <row>
    <udiDi>00616258024585</udiDi>
    <basicUdiDi>0616258TFCN-0050Q5</basicUdiDi>
    <tradeName>MEDRAD® Stellant Syringe Kits</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>SDS-CTP-QFT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:52.135Z</lastUpdated>
  </row>
  <row>
    <udiDi>00616258024592</udiDi>
    <basicUdiDi>0616258TFCN-0050Q5</basicUdiDi>
    <tradeName>MEDRAD® Stellant Syringe Kits</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>SDS-CTP-SCS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:52.122Z</lastUpdated>
  </row>
  <row>
    <udiDi>00616258024608</udiDi>
    <basicUdiDi>0616258TFCN-0050Q5</basicUdiDi>
    <tradeName>MEDRAD® Stellant Syringe Kits</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>SDS-CTP-SPK</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:52.086Z</lastUpdated>
  </row>
  <row>
    <udiDi>00616258024615</udiDi>
    <basicUdiDi>0616258TFCN-0050Q5</basicUdiDi>
    <tradeName>MEDRAD® Stellant Syringe Kits</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>SDS-TRF-CV</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:52.065Z</lastUpdated>
  </row>
  <row>
    <udiDi>00616258024622</udiDi>
    <basicUdiDi>0616258TFCN-0050Q5</basicUdiDi>
    <tradeName>MEDRAD® Stellant Syringe Kits</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>SSS-CTP-QFT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:52.042Z</lastUpdated>
  </row>
  <row>
    <udiDi>00616258024639</udiDi>
    <basicUdiDi>0616258TFCN-0050Q5</basicUdiDi>
    <tradeName>MEDRAD® Stellant Syringe Kits</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>SSS-CTP-SPK</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:52.024Z</lastUpdated>
  </row>
  <row>
    <udiDi>00616258024646</udiDi>
    <basicUdiDi>0616258TFCN-0050Q5</basicUdiDi>
    <tradeName>MEDRAD® Stellant Syringe Kits</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>SSS-QFT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:52.000Z</lastUpdated>
  </row>
  <row>
    <udiDi>00616258024653</udiDi>
    <basicUdiDi>0616258TFCN-0050Q5</basicUdiDi>
    <tradeName>MEDRAD® Stellant Syringe Kits</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>SSS-SPK</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:51.971Z</lastUpdated>
  </row>
  <row>
    <udiDi>00616258024813</udiDi>
    <basicUdiDi>0616258TFCN-0050Q5</basicUdiDi>
    <tradeName>MEDRAD® Stellant Syringe Kits</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>SSS-LP-60-T</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:51.946Z</lastUpdated>
  </row>
  <row>
    <udiDi>00616258024820</udiDi>
    <basicUdiDi>0616258TFCN-0086QS</basicUdiDi>
    <tradeName>MEDRAD® Twist &amp; Go Disposable Syringe 150 mL with Quick Fill Tube</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>Artık piyasada değil</deviceStatus>
    <reference>TAG 150 SYR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:51.928Z</lastUpdated>
  </row>
  <row>
    <udiDi>00616258024868</udiDi>
    <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 DCOV</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:51.906Z</lastUpdated>
  </row>
  <row>
    <udiDi>00616258024905</udiDi>
    <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>
  </row>
  <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>
</eudamedExport>