<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>09345390002953</udiDi>
    <basicUdiDi>934539000TFCN-0100UQ</basicUdiDi>
    <tradeName>MEDRAD® Centargo Replacement Spike</tradeName>
    <deviceName></deviceName>
    <manufacturerName>IMAXEON PTY LTD</manufacturerName>
    <manufacturerSrn>AU-MF-000009702</manufacturerSrn>
    <authorisedRepresentativeName>Bayer Medical Care B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000240</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010401</emdnCode>
    <emdnDescription>SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CENT-RS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:33.590Z</lastUpdated>
  </row>
  <row>
    <udiDi>09345390002960</udiDi>
    <basicUdiDi>934539000TFCN-0100UQ</basicUdiDi>
    <tradeName>MEDRAD® Centargo Day Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>IMAXEON PTY LTD</manufacturerName>
    <manufacturerSrn>AU-MF-000009702</manufacturerSrn>
    <authorisedRepresentativeName>Bayer Medical Care B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000240</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010401</emdnCode>
    <emdnDescription>SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CENT-DS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:33.569Z</lastUpdated>
  </row>
  <row>
    <udiDi>09345390002991</udiDi>
    <basicUdiDi>934539000TFCN-0100UQ</basicUdiDi>
    <tradeName>MEDRAD® Centargo Replacement Spike</tradeName>
    <deviceName></deviceName>
    <manufacturerName>IMAXEON PTY LTD</manufacturerName>
    <manufacturerSrn>AU-MF-000009702</manufacturerSrn>
    <authorisedRepresentativeName>Bayer Medical Care B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000240</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010401</emdnCode>
    <emdnDescription>SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CENT-RS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:33.549Z</lastUpdated>
  </row>
  <row>
    <udiDi>09345390003011</udiDi>
    <basicUdiDi>934539000TFCN-0102UU</basicUdiDi>
    <tradeName>MEDRAD® Salient Contrast Injection System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>IMAXEON PTY LTD</manufacturerName>
    <manufacturerSrn>AU-MF-000009702</manufacturerSrn>
    <authorisedRepresentativeName>Bayer Medical Care B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000240</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039013</emdnCode>
    <emdnDescription>ANGIOGRAPHIC INJECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC009S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:33.524Z</lastUpdated>
  </row>
  <row>
    <udiDi>09345390003028</udiDi>
    <basicUdiDi>934539000TFCN-0102UU</basicUdiDi>
    <tradeName>MEDRAD® Salient Contrast Injection System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>IMAXEON PTY LTD</manufacturerName>
    <manufacturerSrn>AU-MF-000009702</manufacturerSrn>
    <authorisedRepresentativeName>Bayer Medical Care B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000240</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039013</emdnCode>
    <emdnDescription>ANGIOGRAPHIC INJECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC009SW</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:33.501Z</lastUpdated>
  </row>
  <row>
    <udiDi>09345390003035</udiDi>
    <basicUdiDi>934539000TFCN-0102UU</basicUdiDi>
    <tradeName>MEDRAD® Salient Contrast Injection System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>IMAXEON PTY LTD</manufacturerName>
    <manufacturerSrn>AU-MF-000009702</manufacturerSrn>
    <authorisedRepresentativeName>Bayer Medical Care B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000240</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039013</emdnCode>
    <emdnDescription>ANGIOGRAPHIC INJECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC009DW</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:33.482Z</lastUpdated>
  </row>
  <row>
    <udiDi>09345390003295</udiDi>
    <basicUdiDi>934539000TFCN-0102UU</basicUdiDi>
    <tradeName>MEDRAD® Salient Contrast Injection System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>IMAXEON PTY LTD</manufacturerName>
    <manufacturerSrn>AU-MF-000009702</manufacturerSrn>
    <authorisedRepresentativeName>Bayer Medical Care B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000240</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039013</emdnCode>
    <emdnDescription>ANGIOGRAPHIC INJECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC009SW</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:33.463Z</lastUpdated>
  </row>
  <row>
    <udiDi>09345390003318</udiDi>
    <basicUdiDi>934539000TFCN-0102UU</basicUdiDi>
    <tradeName>MEDRAD® Salient Contrast Injection System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>IMAXEON PTY LTD</manufacturerName>
    <manufacturerSrn>AU-MF-000009702</manufacturerSrn>
    <authorisedRepresentativeName>Bayer Medical Care B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000240</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039013</emdnCode>
    <emdnDescription>ANGIOGRAPHIC INJECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC009DW</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:33.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>09345390003325</udiDi>
    <basicUdiDi>934539000TFCN-0102UU</basicUdiDi>
    <tradeName>MEDRAD® Salient Contrast Injection System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>IMAXEON PTY LTD</manufacturerName>
    <manufacturerSrn>AU-MF-000009702</manufacturerSrn>
    <authorisedRepresentativeName>Bayer Medical Care B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000240</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039013</emdnCode>
    <emdnDescription>ANGIOGRAPHIC INJECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC009S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:33.422Z</lastUpdated>
  </row>
  <row>
    <udiDi>09345390003356</udiDi>
    <basicUdiDi>934539000TFCN-0099VY</basicUdiDi>
    <tradeName>MEDRAD® Centargo CT Injector System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>IMAXEON PTY LTD</manufacturerName>
    <manufacturerSrn>AU-MF-000009702</manufacturerSrn>
    <authorisedRepresentativeName>Bayer Medical Care B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000240</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039013</emdnCode>
    <emdnDescription>ANGIOGRAPHIC INJECTORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>CENT-SYS-OCS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:33.403Z</lastUpdated>
  </row>
  <row>
    <udiDi>09345390003370</udiDi>
    <basicUdiDi>934539000TFCN-0102UU</basicUdiDi>
    <tradeName>MEDRAD® Salient Contrast Injection System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>IMAXEON PTY LTD</manufacturerName>
    <manufacturerSrn>AU-MF-000009702</manufacturerSrn>
    <authorisedRepresentativeName>Bayer Medical Care B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000240</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039013</emdnCode>
    <emdnDescription>ANGIOGRAPHIC INJECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC009S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:33.385Z</lastUpdated>
  </row>
  <row>
    <udiDi>09345390003387</udiDi>
    <basicUdiDi>934539000TFCN-0102UU</basicUdiDi>
    <tradeName>MEDRAD® Salient Contrast Injection System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>IMAXEON PTY LTD</manufacturerName>
    <manufacturerSrn>AU-MF-000009702</manufacturerSrn>
    <authorisedRepresentativeName>Bayer Medical Care B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000240</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039013</emdnCode>
    <emdnDescription>ANGIOGRAPHIC INJECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC009SW</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:33.366Z</lastUpdated>
  </row>
  <row>
    <udiDi>09345390003394</udiDi>
    <basicUdiDi>934539000TFCN-0102UU</basicUdiDi>
    <tradeName>MEDRAD® Salient Contrast Injection System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>IMAXEON PTY LTD</manufacturerName>
    <manufacturerSrn>AU-MF-000009702</manufacturerSrn>
    <authorisedRepresentativeName>Bayer Medical Care B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000240</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039013</emdnCode>
    <emdnDescription>ANGIOGRAPHIC INJECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC009DW</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:33.338Z</lastUpdated>
  </row>
</eudamedExport>