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    <tradeName>MEDRAD® Salient MEDRAD® Vistron Plus Contrast Injection System</tradeName>
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    <manufacturerName>IMAXEON PTY LTD</manufacturerName>
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    <tradeName>MEDRAD® Salient MEDRAD® Vistron Plus Contrast Injection System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>IMAXEON PTY LTD</manufacturerName>
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    <emdnDescription>SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZY5152</reference>
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    <udiDi>09345390000904</udiDi>
    <basicUdiDi>934539000TFCN-0103UW</basicUdiDi>
    <tradeName>MEDRAD® Salient MEDRAD® Vistron Plus Contrast Injection System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>IMAXEON PTY LTD</manufacturerName>
    <manufacturerSrn>AU-MF-000009702</manufacturerSrn>
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    <legislation>MDR 2017/745</legislation>
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    <emdnDescription>SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZY5152</reference>
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    <basicUdiDi>934539000TFCN-0103UW</basicUdiDi>
    <tradeName>MEDRAD® Salient MEDRAD® Vistron Plus Contrast Injection System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>IMAXEON PTY LTD</manufacturerName>
    <manufacturerSrn>AU-MF-000009702</manufacturerSrn>
    <authorisedRepresentativeName>Bayer Medical Care B.V.</authorisedRepresentativeName>
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    <emdnDescription>SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <udiDi>09345390000829</udiDi>
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    <tradeName>MEDRAD® Salient 150 cm Y Extension Tube</tradeName>
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    <manufacturerName>IMAXEON PTY LTD</manufacturerName>
    <manufacturerSrn>AU-MF-000009702</manufacturerSrn>
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    <legislation>MDR 2017/745</legislation>
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    <emdnDescription>SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZY5454</reference>
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    <tradeName>MEDRAD® Mark 7 Arterion Injection System</tradeName>
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    <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>
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    <emdnDescription>ANGIOGRAPHIC INJECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VF HC</reference>
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    <lastUpdated>2026-06-22T14:17:53.392Z</lastUpdated>
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    <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>
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    <emdnDescription>MAGNETIC RESONANCE INJECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MRXP 200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:17:53.374Z</lastUpdated>
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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>2026-06-22T14:17:53.356Z</lastUpdated>
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    <tradeName>MEDRAD® Avanta Fluid Management Injection System</tradeName>
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    <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>
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    <lastUpdated>2026-06-22T14:17:53.337Z</lastUpdated>
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    <tradeName>MEDRAD® Avanta Fluid Management Injection System</tradeName>
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    <manufacturerName>Bayer Medical Care Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007050</manufacturerSrn>
    <authorisedRepresentativeName>Bayer Medical Care B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
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    <emdnCode></emdnCode>
    <emdnDescription>FLUIDS HEATING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVA 500 BTLH-M</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <tradeName>MEDRAD® Avanta Fluid Management Injection System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bayer Medical Care Inc.</manufacturerName>
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    <emdnDescription>FLUIDS HEATING SYSTEMS</emdnDescription>
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    <tradeName>MEDRAD® Avanta Fluid Management Injection System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bayer Medical Care Inc.</manufacturerName>
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    <manufacturerName>Bayer Medical Care Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007050</manufacturerSrn>
    <authorisedRepresentativeName>Bayer Medical Care B.V.</authorisedRepresentativeName>
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    <manufacturerName>Bayer Medical Care Inc.</manufacturerName>
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    <tradeName>Radimetrics® Enterprise Application</tradeName>
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    <manufacturerName>Bayer Medical Care Inc.</manufacturerName>
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    <authorisedRepresentativeName>Bayer Medical Care B.V.</authorisedRepresentativeName>
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    <emdnDescription>RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
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    <reference>EXPOSURE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <tradeName>MEDRAD® Stellant CT Injection System with Certegra Workstation</tradeName>
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    <manufacturerName>Bayer Medical Care Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007050</manufacturerSrn>
    <authorisedRepresentativeName>Bayer Medical Care B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000240</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>FLUIDS HEATING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SSH 200F</reference>
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    <tradeName>MEDRAD® Mark 7 Arterion Injection System</tradeName>
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    <manufacturerName>Bayer Medical Care Inc.</manufacturerName>
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    <authorisedRepresentativeName>Bayer Medical Care B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000240</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ANGIOGRAPHIC INJECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ART 700</reference>
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    <tradeName>MEDRAD® Intego</tradeName>
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    <manufacturerName>Bayer Medical Care Inc.</manufacturerName>
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    <authorisedRepresentativeName>Bayer Medical Care B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000240</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ADMINISTRATION KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INT CPS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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