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    <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>
    <authorisedRepresentativeSrn>NL-AR-000000240</authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZY5151</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T03:39:40.963Z</lastUpdated>
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    <udiDi>09345390002816</udiDi>
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    <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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    <udiDi>09345390000560</udiDi>
    <basicUdiDi>934539000TFCN-0103UW</basicUdiDi>
    <tradeName>MEDRAD® Salient MEDRAD® Vistron Plus Contrast Injection System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>IMAXEON PTY LTD</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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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>
    <authorisedRepresentativeName>Bayer Medical Care B.V.</authorisedRepresentativeName>
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    <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>ZY5152</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <udiDi>09345390002830</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>
    <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>ZY5152</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T03:39:29.803Z</lastUpdated>
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    <udiDi>09345390000829</udiDi>
    <basicUdiDi>934539000TFCN-0103UW</basicUdiDi>
    <tradeName>MEDRAD® Salient 150 cm Y Extension Tube</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>ZY5454</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T03:39:29.132Z</lastUpdated>
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    <udiDi>06938327925895</udiDi>
    <basicUdiDi>69383279204XF</basicUdiDi>
    <tradeName>Single-use Sterile High-pressure Angiographic Syringes and Accessories</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Boon Medical Supply Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018400</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A02010401</emdnCode>
    <emdnDescription>SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300107</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:31:53.508Z</lastUpdated>
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    <udiDi>06938327925529</udiDi>
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    <tradeName>Single-use Sterile High-pressure Angiographic Syringes and Accessories</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Boon Medical Supply Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018400</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A02010401</emdnCode>
    <emdnDescription>SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100205A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:31:52.279Z</lastUpdated>
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    <udiDi>06938327925512</udiDi>
    <basicUdiDi>69383279205XH</basicUdiDi>
    <tradeName>Single-use Sterile High-pressure Angiographic Syringes and Accessories</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Boon Medical Supply Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018400</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A02010401</emdnCode>
    <emdnDescription>SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100205</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:31:51.100Z</lastUpdated>
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    <udiDi>06938327925178</udiDi>
    <basicUdiDi>69383279206XK</basicUdiDi>
    <tradeName>Single-use Sterile High-pressure Angiographic Syringes and Accessories</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Boon Medical Supply Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018400</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A02010401</emdnCode>
    <emdnDescription>SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100120P</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:31:49.885Z</lastUpdated>
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  <row>
    <udiDi>06938327925109</udiDi>
    <basicUdiDi>69383279206XK</basicUdiDi>
    <tradeName>Single-use Sterile High-pressure Angiographic Syringes and Accessories</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Boon Medical Supply Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018400</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A02010401</emdnCode>
    <emdnDescription>SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100119C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:31:47.478Z</lastUpdated>
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    <udiDi>06938327925062</udiDi>
    <basicUdiDi>69383279206XK</basicUdiDi>
    <tradeName>Single-use Sterile High-pressure Angiographic Syringes and Accessories</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Boon Medical Supply Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018400</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A02010401</emdnCode>
    <emdnDescription>SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100118E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:31:46.277Z</lastUpdated>
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    <udiDi>06938327924713</udiDi>
    <basicUdiDi>69383279206XK</basicUdiDi>
    <tradeName>Single-use Sterile High-pressure Angiographic Syringes and Accessories</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Boon Medical Supply Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018400</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
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    <emdnCode>A02010401</emdnCode>
    <emdnDescription>SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100113D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:31:45.141Z</lastUpdated>
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    <udiDi>06938327924614</udiDi>
    <basicUdiDi>69383279204XF</basicUdiDi>
    <tradeName>Single-use Sterile High-pressure Angiographic Syringes and Accessories</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Boon Medical Supply Co.,Ltd.</manufacturerName>
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    <emdnCode>A02010401</emdnCode>
    <emdnDescription>SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100112</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:31:43.902Z</lastUpdated>
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    <udiDi>06938327924515</udiDi>
    <basicUdiDi>69383279204XF</basicUdiDi>
    <tradeName>Single-use Sterile High-pressure Angiographic Syringes and Accessories</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Boon Medical Supply Co.,Ltd.</manufacturerName>
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    <emdnCode>A02010401</emdnCode>
    <emdnDescription>SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100109B</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:31:42.699Z</lastUpdated>
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    <udiDi>06938327924492</udiDi>
    <basicUdiDi>69383279204XF</basicUdiDi>
    <tradeName>Single-use Sterile High-pressure Angiographic Syringes and Accessories</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Boon Medical Supply Co.,Ltd.</manufacturerName>
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    <emdnCode>A02010401</emdnCode>
    <emdnDescription>SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100109</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:31:40.316Z</lastUpdated>
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    <udiDi>06938327924447</udiDi>
    <basicUdiDi>69383279204XF</basicUdiDi>
    <tradeName>Single-use Sterile High-pressure Angiographic Syringes and Accessories</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Boon Medical Supply Co.,Ltd.</manufacturerName>
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    <emdnCode>A02010401</emdnCode>
    <emdnDescription>SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100108</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:31:39.149Z</lastUpdated>
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    <udiDi>06938327924218</udiDi>
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    <tradeName>Single-use Sterile High-pressure Angiographic Syringes and Accessories</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Boon Medical Supply Co.,Ltd.</manufacturerName>
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    <legislation>UNKNOWN</legislation>
    <emdnCode>A02010401</emdnCode>
    <emdnDescription>SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100104</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:31:37.892Z</lastUpdated>
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  <row>
    <udiDi>06938327924164</udiDi>
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    <tradeName>Single-use Sterile High-pressure Angiographic Syringes and Accessories</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Boon Medical Supply Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018400</manufacturerSrn>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A02010401</emdnCode>
    <emdnDescription>SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100103G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:31:36.685Z</lastUpdated>
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  <row>
    <udiDi>06938327923976</udiDi>
    <basicUdiDi>69383279204XF</basicUdiDi>
    <tradeName>Single-use Sterile High-pressure Angiographic Syringes and Accessories</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Boon Medical Supply Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018400</manufacturerSrn>
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    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode>A02010401</emdnCode>
    <emdnDescription>SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100110D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:31:34.393Z</lastUpdated>
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