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    <tradeName>MEDRAD® Spectris Solaris EP 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 I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CONTROLLERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SSMR START</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:51.470Z</lastUpdated>
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    <udiDi>00616258026350</udiDi>
    <basicUdiDi>0616258TFCN-0089I4G</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 I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MRXP PFA YW</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <udiDi>00616258026367</udiDi>
    <basicUdiDi>0616258TFCN-0089I4G</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 I</riskClass>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription>VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MRXP PFA GN</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:51.417Z</lastUpdated>
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    <udiDi>00616258026374</udiDi>
    <basicUdiDi>0616258TFCN-0089I4G</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 I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MRXP PFA PE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:51.395Z</lastUpdated>
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    <udiDi>00616258026381</udiDi>
    <basicUdiDi>0616258TFCN-0089I4G</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 I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MRXP PFA GY</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:51.365Z</lastUpdated>
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    <udiDi>00616258026473</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 100F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:51.336Z</lastUpdated>
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    <udiDi>00616258026619</udiDi>
    <basicUdiDi>0616258D-0001890459GC</basicUdiDi>
    <tradeName>MEDRAD® Stellant Multi-Patient Disposables 2.0</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-SPD-250</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:51.246Z</lastUpdated>
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    <udiDi>00616258027135</udiDi>
    <basicUdiDi>0616258TFCN-0009Q8</basicUdiDi>
    <tradeName>Low Pressure Connector Tubing</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>LPDCT 160</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:51.192Z</lastUpdated>
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    <udiDi>00616258027166</udiDi>
    <basicUdiDi>0616258D-0001890459GC</basicUdiDi>
    <tradeName>MEDRAD® Stellant Multi-Patient Disposables 2.0</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-SPD-250</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:51.172Z</lastUpdated>
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    <udiDi>00616258027173</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>2026-06-22T14:17:51.153Z</lastUpdated>
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    <udiDi>00616258027180</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>2026-06-22T14:17:51.139Z</lastUpdated>
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    <udiDi>00616258027197</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>2026-06-22T14:17:51.124Z</lastUpdated>
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    <udiDi>00616258027203</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>2026-06-22T14:17:51.102Z</lastUpdated>
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    <udiDi>00616258027210</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>2026-06-22T14:17:51.084Z</lastUpdated>
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    <udiDi>00616258027227</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>2026-06-22T14:17:51.065Z</lastUpdated>
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    <udiDi>00616258027234</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>2026-06-22T14:17:51.049Z</lastUpdated>
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    <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>2026-06-22T14:17:51.028Z</lastUpdated>
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    <basicUdiDi>0616258TFCN-0104Q3</basicUdiDi>
    <tradeName>ISI2</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></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>ISI2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:51.009Z</lastUpdated>
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    <udiDi>00616258027401</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 100F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:50.984Z</lastUpdated>
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    <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>2026-06-22T14:17:50.964Z</lastUpdated>
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