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<eudamedExport entity="devices">
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    <udiDi>09351351001163</udiDi>
    <basicUdiDi>B-09351351001163</basicUdiDi>
    <tradeName>Khelix Quadpolar Fixed Electrophysiology Catheter</tradeName>
    <deviceName>Khelix Quadpolar Fixed Electrophysiology Catheter [5SSF-ANN-4A555]</deviceName>
    <manufacturerName>CathRx Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000002757</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C02010401</emdnCode>
    <emdnDescription>ARRHYTHMOLOGY MULTIPOLAR DIAGNOSTIC CATHETERS, CONVENTIONAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5SSF-ANN-4A555</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T00:59:16.636Z</lastUpdated>
  </row>
  <row>
    <udiDi>09351351001156</udiDi>
    <basicUdiDi>B-09351351001156</basicUdiDi>
    <tradeName>Khelix Duodecapolar Steerable Electrophysiology Catheter</tradeName>
    <deviceName>Khelix Duodecapolar Steerable Electrophysiology Catheter [SS2-R0U-20A6282]</deviceName>
    <manufacturerName>CathRx Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000002757</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C02010403</emdnCode>
    <emdnDescription>ARRHYTHMOLOGY MULTIPOLAR DIAGNOSTIC CATHETERS, ADJUSTABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS2-R0U-20A6282</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T00:59:15.849Z</lastUpdated>
  </row>
  <row>
    <udiDi>09351351000050</udiDi>
    <basicUdiDi>B-09351351000050</basicUdiDi>
    <tradeName>Khelix Decapolar Steerable Electrophysiology Catheter</tradeName>
    <deviceName>Khelix Decapolar Steerable Electrophysiology Catheter [SS1-F0U-10A6252]</deviceName>
    <manufacturerName>CathRx Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000002757</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C02010403</emdnCode>
    <emdnDescription>ARRHYTHMOLOGY MULTIPOLAR DIAGNOSTIC CATHETERS, ADJUSTABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS1-F0U-10A6252</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T00:59:12.625Z</lastUpdated>
  </row>
  <row>
    <udiDi>09351351000043</udiDi>
    <basicUdiDi>B-09351351000043</basicUdiDi>
    <tradeName>Khelix Decapolar Steerable Electrophysiology Catheter</tradeName>
    <deviceName>Khelix Decapolar Steerable Electrophysiology Catheter [SS1-D0U-10A6252]</deviceName>
    <manufacturerName>CathRx Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000002757</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C02010403</emdnCode>
    <emdnDescription>ARRHYTHMOLOGY MULTIPOLAR DIAGNOSTIC CATHETERS, ADJUSTABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS1-D0U-10A6252</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T00:59:11.861Z</lastUpdated>
  </row>
  <row>
    <udiDi>09351351000357</udiDi>
    <basicUdiDi>B-09351351000357</basicUdiDi>
    <tradeName>Khelix Decapolar Steerable Electrophysiology Catheter</tradeName>
    <deviceName>Khelix Decapolar Steerable Electrophysiology Catheter [SS1-G0U-10A6252]</deviceName>
    <manufacturerName>CathRx Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000002757</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C02010403</emdnCode>
    <emdnDescription>ARRHYTHMOLOGY MULTIPOLAR DIAGNOSTIC CATHETERS, ADJUSTABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS1-G0U-10A6252</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-20T03:42:28.279Z</lastUpdated>
  </row>
  <row>
    <udiDi>09351351000111</udiDi>
    <basicUdiDi>B-09351351000111</basicUdiDi>
    <tradeName>Khelix Duodecapolar Variable Loop Steerable Electrophysiology Catheter</tradeName>
    <deviceName>Khelix Duodecapolar Variable Loop Steerable Electrophysiology Catheter [SC2-B2515U-20P7262]</deviceName>
    <manufacturerName>CathRx Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000002757</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C02010403</emdnCode>
    <emdnDescription>ARRHYTHMOLOGY MULTIPOLAR DIAGNOSTIC CATHETERS, ADJUSTABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC2-B2515U-20P7262</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T20:55:28.988Z</lastUpdated>
  </row>
  <row>
    <udiDi>09351351000081</udiDi>
    <basicUdiDi>B-09351351000081</basicUdiDi>
    <tradeName>Khelix Decapolar Fixed Loop Steerable Electrophysiology Catheter</tradeName>
    <deviceName>Khelix Decapolar Fixed Loop Steerable Electrophysiology Catheter [SC1-B20U-10P7666]</deviceName>
    <manufacturerName>CathRx Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000002757</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C02010403</emdnCode>
    <emdnDescription>ARRHYTHMOLOGY MULTIPOLAR DIAGNOSTIC CATHETERS, ADJUSTABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC1-B20U-10P7666</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T20:55:23.982Z</lastUpdated>
  </row>
  <row>
    <udiDi>09351351000074</udiDi>
    <basicUdiDi>B-09351351000074</basicUdiDi>
    <tradeName>Khelix Decapolar Fixed Loop Steerable Electrophysiology Catheter</tradeName>
    <deviceName>Khelix Decapolar Fixed Loop Steerable Electrophysiology Catheter [SC1-B15U-10P7555]</deviceName>
    <manufacturerName>CathRx Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000002757</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C02010403</emdnCode>
    <emdnDescription>ARRHYTHMOLOGY MULTIPOLAR DIAGNOSTIC CATHETERS, ADJUSTABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC1-B15U-10P7555</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T20:55:23.941Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850298007096</udiDi>
    <basicUdiDi>0850298007099H</basicUdiDi>
    <tradeName>00850298007096</tradeName>
    <deviceName>Monitoring Lead Wires for EMG Monitoring 60" Leads Set of 2</deviceName>
    <manufacturerName>Somatics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000011550</manufacturerSrn>
    <authorisedRepresentativeName>FBI Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009421</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C02010401</emdnCode>
    <emdnDescription>ARRHYTHMOLOGY MULTIPOLAR DIAGNOSTIC CATHETERS, CONVENTIONAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELDS-BR</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:32:25.172Z</lastUpdated>
  </row>
  <row>
    <udiDi>09351351000104</udiDi>
    <basicUdiDi>B-09351351000104</basicUdiDi>
    <tradeName>Khelix</tradeName>
    <deviceName>Khelix Decapolar Variable Loop Steerable Electrophysiology Catheter</deviceName>
    <manufacturerName>CathRx Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000002757</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C02010403</emdnCode>
    <emdnDescription>ARRHYTHMOLOGY MULTIPOLAR DIAGNOSTIC CATHETERS, ADJUSTABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC1-B2515U-10P7888</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:49:48.141Z</lastUpdated>
  </row>
</eudamedExport>