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<eudamedExport entity="devices">
  <row>
    <udiDi>00857688007353</udiDi>
    <basicUdiDi>B-00857688007353</basicUdiDi>
    <tradeName>remede</tradeName>
    <deviceName>remede Programmer Power Supply and USB cable</deviceName>
    <manufacturerName>ZOLL Respicardia, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023953</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0206</emdnCode>
    <emdnDescription>FRENIC NERVE IMPLANTABLE NEUROSTIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:34:45.082Z</lastUpdated>
  </row>
  <row>
    <udiDi>00857688007346</udiDi>
    <basicUdiDi>B-00857688007346</basicUdiDi>
    <tradeName>remede</tradeName>
    <deviceName>remede eIPG</deviceName>
    <manufacturerName>ZOLL Respicardia, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023953</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0206</emdnCode>
    <emdnDescription>FRENIC NERVE IMPLANTABLE NEUROSTIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:34:29.819Z</lastUpdated>
  </row>
  <row>
    <udiDi>00857688007339</udiDi>
    <basicUdiDi>B-00857688007339</basicUdiDi>
    <tradeName>remede</tradeName>
    <deviceName>remede Flexible Programming Wand</deviceName>
    <manufacturerName>ZOLL Respicardia, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023953</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0206</emdnCode>
    <emdnDescription>FRENIC NERVE IMPLANTABLE NEUROSTIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1004A-F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:34:28.237Z</lastUpdated>
  </row>
  <row>
    <udiDi>00857688007322</udiDi>
    <basicUdiDi>B-00857688007322</basicUdiDi>
    <tradeName>remede</tradeName>
    <deviceName>remede Programming Wand</deviceName>
    <manufacturerName>ZOLL Respicardia, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023953</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0206</emdnCode>
    <emdnDescription>FRENIC NERVE IMPLANTABLE NEUROSTIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1004A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:34:25.818Z</lastUpdated>
  </row>
  <row>
    <udiDi>00857688007315</udiDi>
    <basicUdiDi>B-00857688007315</basicUdiDi>
    <tradeName>remede System</tradeName>
    <deviceName>remede Programmer</deviceName>
    <manufacturerName>ZOLL Respicardia, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023953</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0206</emdnCode>
    <emdnDescription>FRENIC NERVE IMPLANTABLE NEUROSTIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1002A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:34:24.231Z</lastUpdated>
  </row>
  <row>
    <udiDi>00857688007308</udiDi>
    <basicUdiDi>B-00857688007308</basicUdiDi>
    <tradeName>Respiguide Delivery System</tradeName>
    <deviceName>Respiguide Delivery System</deviceName>
    <manufacturerName>ZOLL Respicardia, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023953</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0206</emdnCode>
    <emdnDescription>FRENIC NERVE IMPLANTABLE NEUROSTIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7120-K</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:34:23.411Z</lastUpdated>
  </row>
  <row>
    <udiDi>00857688007292</udiDi>
    <basicUdiDi>B-00857688007292</basicUdiDi>
    <tradeName>Respiguide Delivery System</tradeName>
    <deviceName>Respiguide Delivery System</deviceName>
    <manufacturerName>ZOLL Respicardia, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023953</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0206</emdnCode>
    <emdnDescription>FRENIC NERVE IMPLANTABLE NEUROSTIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7090-K</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:34:21.812Z</lastUpdated>
  </row>
  <row>
    <udiDi>00857688007285</udiDi>
    <basicUdiDi>B-00857688007285</basicUdiDi>
    <tradeName>Respiguide Delivery System</tradeName>
    <deviceName>Respiguide Delivery System</deviceName>
    <manufacturerName>ZOLL Respicardia, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023953</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0206</emdnCode>
    <emdnDescription>FRENIC NERVE IMPLANTABLE NEUROSTIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7000-K</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:34:19.408Z</lastUpdated>
  </row>
  <row>
    <udiDi>00857688007278</udiDi>
    <basicUdiDi>B-00857688007278</basicUdiDi>
    <tradeName>Respiguide Delivery System</tradeName>
    <deviceName>Respiguide Delivery System</deviceName>
    <manufacturerName>ZOLL Respicardia, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023953</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0206</emdnCode>
    <emdnDescription>FRENIC NERVE IMPLANTABLE NEUROSTIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7120-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:34:17.811Z</lastUpdated>
  </row>
  <row>
    <udiDi>00857688007261</udiDi>
    <basicUdiDi>B-00857688007261</basicUdiDi>
    <tradeName>Respiguide Delivery System</tradeName>
    <deviceName>Respiguide Delivery System</deviceName>
    <manufacturerName>ZOLL Respicardia, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023953</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0206</emdnCode>
    <emdnDescription>FRENIC NERVE IMPLANTABLE NEUROSTIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7090-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:34:17.006Z</lastUpdated>
  </row>
  <row>
    <udiDi>00857688007254</udiDi>
    <basicUdiDi>B-00857688007254</basicUdiDi>
    <tradeName>Respiguide Delivery System</tradeName>
    <deviceName>Respiguide Delivery System</deviceName>
    <manufacturerName>ZOLL Respicardia, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023953</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0206</emdnCode>
    <emdnDescription>FRENIC NERVE IMPLANTABLE NEUROSTIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7000-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:34:15.422Z</lastUpdated>
  </row>
  <row>
    <udiDi>00857688007247</udiDi>
    <basicUdiDi>B-00857688007247</basicUdiDi>
    <tradeName>remedē Respistim</tradeName>
    <deviceName>remedē Respistim LQS Stimulation Lead</deviceName>
    <manufacturerName>ZOLL Respicardia, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023953</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0206</emdnCode>
    <emdnDescription>FRENIC NERVE IMPLANTABLE NEUROSTIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4085</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:34:13.010Z</lastUpdated>
  </row>
  <row>
    <udiDi>00857688007230</udiDi>
    <basicUdiDi>B-00857688007230</basicUdiDi>
    <tradeName>remedē Respistim</tradeName>
    <deviceName>remedē Respistim LQS Stimulation Lead</deviceName>
    <manufacturerName>ZOLL Respicardia, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023953</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0206</emdnCode>
    <emdnDescription>FRENIC NERVE IMPLANTABLE NEUROSTIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4065</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:34:11.420Z</lastUpdated>
  </row>
  <row>
    <udiDi>00857688007223</udiDi>
    <basicUdiDi>B-00857688007223</basicUdiDi>
    <tradeName>remedē Respistim</tradeName>
    <deviceName>remedē Respistim LQS Stimulation Lead</deviceName>
    <manufacturerName>ZOLL Respicardia, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023953</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0206</emdnCode>
    <emdnDescription>FRENIC NERVE IMPLANTABLE NEUROSTIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4055</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:34:10.606Z</lastUpdated>
  </row>
  <row>
    <udiDi>00857688007216</udiDi>
    <basicUdiDi>B-00857688007216</basicUdiDi>
    <tradeName>remedē Respistim</tradeName>
    <deviceName>remedē Respistim LQS Stimulation Lead</deviceName>
    <manufacturerName>ZOLL Respicardia, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023953</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0206</emdnCode>
    <emdnDescription>FRENIC NERVE IMPLANTABLE NEUROSTIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4045</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:34:09.028Z</lastUpdated>
  </row>
  <row>
    <udiDi>00857688007162</udiDi>
    <basicUdiDi>B-00857688007162</basicUdiDi>
    <tradeName>remedē Respistim</tradeName>
    <deviceName>remedē Respistim R Stimulation Lead</deviceName>
    <manufacturerName>ZOLL Respicardia, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023953</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0206</emdnCode>
    <emdnDescription>FRENIC NERVE IMPLANTABLE NEUROSTIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3206</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:34:06.601Z</lastUpdated>
  </row>
  <row>
    <udiDi>00857688007155</udiDi>
    <basicUdiDi>B-00857688007155</basicUdiDi>
    <tradeName>remedē Respistim</tradeName>
    <deviceName>remedē Respistim R Stimulation Lead</deviceName>
    <manufacturerName>ZOLL Respicardia, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023953</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0206</emdnCode>
    <emdnDescription>FRENIC NERVE IMPLANTABLE NEUROSTIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3205</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:34:05.004Z</lastUpdated>
  </row>
  <row>
    <udiDi>00857688007148</udiDi>
    <basicUdiDi>B-00857688007148</basicUdiDi>
    <tradeName>remedē Respistim</tradeName>
    <deviceName>remedē Respistim R Stimulation Lead</deviceName>
    <manufacturerName>ZOLL Respicardia, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023953</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0206</emdnCode>
    <emdnDescription>FRENIC NERVE IMPLANTABLE NEUROSTIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3204</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:34:04.211Z</lastUpdated>
  </row>
  <row>
    <udiDi>00857688007131</udiDi>
    <basicUdiDi>B-00857688007131</basicUdiDi>
    <tradeName>remedē Respistim</tradeName>
    <deviceName>remedē Respistim R Stimulation Lead</deviceName>
    <manufacturerName>ZOLL Respicardia, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023953</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0206</emdnCode>
    <emdnDescription>FRENIC NERVE IMPLANTABLE NEUROSTIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3203</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:34:02.615Z</lastUpdated>
  </row>
  <row>
    <udiDi>00857688007124</udiDi>
    <basicUdiDi>B-00857688007124</basicUdiDi>
    <tradeName>remedē Respistim</tradeName>
    <deviceName>remedē Respistim R Stimulation Lead</deviceName>
    <manufacturerName>ZOLL Respicardia, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023953</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0206</emdnCode>
    <emdnDescription>FRENIC NERVE IMPLANTABLE NEUROSTIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3202</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:34:00.202Z</lastUpdated>
  </row>
</eudamedExport>