<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>09345390000737</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>DC009D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:33.982Z</lastUpdated>
  </row>
  <row>
    <udiDi>09345390000744</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>2026-06-21T14:34:33.965Z</lastUpdated>
  </row>
  <row>
    <udiDi>09345390000751</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>2026-06-21T14:34:33.952Z</lastUpdated>
  </row>
  <row>
    <udiDi>09345390001123</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>Piyasada</deviceStatus>
    <reference>CENT-SYS-BAT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:33.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>09345390001185</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>Piyasada</deviceStatus>
    <reference>CENT-SYS-BAT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:33.917Z</lastUpdated>
  </row>
  <row>
    <udiDi>09345390001192</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>Piyasada</deviceStatus>
    <reference>CENT-SYS-OCS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:33.904Z</lastUpdated>
  </row>
  <row>
    <udiDi>09345390001215</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>2026-06-21T14:34:33.867Z</lastUpdated>
  </row>
  <row>
    <udiDi>09345390001222</udiDi>
    <basicUdiDi>934539000TFCN-0100UQ</basicUdiDi>
    <tradeName>MEDRAD® Centargo Patient Line</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-PL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:33.846Z</lastUpdated>
  </row>
  <row>
    <udiDi>09345390001253</udiDi>
    <basicUdiDi>934539000TFCN-0100UQ</basicUdiDi>
    <tradeName>MEDRAD® Centargo Patient Line</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-PL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:33.825Z</lastUpdated>
  </row>
  <row>
    <udiDi>09345390001345</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>2026-06-21T14:34:33.804Z</lastUpdated>
  </row>
  <row>
    <udiDi>09345390001352</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>2026-06-21T14:34:33.791Z</lastUpdated>
  </row>
  <row>
    <udiDi>09345390001376</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>2026-06-21T14:34:33.779Z</lastUpdated>
  </row>
  <row>
    <udiDi>09345390001475</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>Piyasada</deviceStatus>
    <reference>CENT-SYS-BAT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:33.759Z</lastUpdated>
  </row>
  <row>
    <udiDi>09345390002137</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>Piyasada</deviceStatus>
    <reference>CENT-SYS-BAT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:33.736Z</lastUpdated>
  </row>
  <row>
    <udiDi>09345390002151</udiDi>
    <basicUdiDi>934539000TFCN-0100UQ</basicUdiDi>
    <tradeName>MEDRAD® Centargo Patient Line (350cm)</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-PL-350</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:33.711Z</lastUpdated>
  </row>
  <row>
    <udiDi>09345390002335</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>2026-06-21T14:34:33.679Z</lastUpdated>
  </row>
  <row>
    <udiDi>09345390002366</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>Piyasada</deviceStatus>
    <reference>CENT-SYS-BAT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:33.656Z</lastUpdated>
  </row>
  <row>
    <udiDi>09345390002915</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>Piyasada</deviceStatus>
    <reference>CENT-SYS-BAT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:33.611Z</lastUpdated>
  </row>
  <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>
</eudamedExport>