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    <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>3201</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:33:58.601Z</lastUpdated>
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    <udiDi>00857688007100</udiDi>
    <basicUdiDi>B-00857688007100</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>
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    <riskClass>AIMDD</riskClass>
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    <emdnCode>J0206</emdnCode>
    <emdnDescription>FRENIC NERVE IMPLANTABLE NEUROSTIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-05T08:33:57.802Z</lastUpdated>
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    <udiDi>00857688007094</udiDi>
    <basicUdiDi>B-00857688007094</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>
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    <emdnCode>J0206</emdnCode>
    <emdnDescription>FRENIC NERVE IMPLANTABLE NEUROSTIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:33:56.196Z</lastUpdated>
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    <udiDi>00857688007087</udiDi>
    <basicUdiDi>B-00857688007087</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>3104</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:33:53.795Z</lastUpdated>
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    <udiDi>00857688007070</udiDi>
    <basicUdiDi>B-00857688007070</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>3103</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:33:52.196Z</lastUpdated>
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    <udiDi>00857688007063</udiDi>
    <basicUdiDi>B-00857688007063</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>3102</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:33:51.409Z</lastUpdated>
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    <udiDi>00857688007056</udiDi>
    <basicUdiDi>B-00857688007056</basicUdiDi>
    <tradeName>remede 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>3101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:33:49.787Z</lastUpdated>
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    <udiDi>00857688007001</udiDi>
    <basicUdiDi>B-00857688007001</basicUdiDi>
    <tradeName>remede System</tradeName>
    <deviceName>remedē® Implantable Pulse Generator (IPG)</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>1001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:33:45.811Z</lastUpdated>
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