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    <tradeName>remedē Respistim</tradeName>
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    <manufacturerName>ZOLL Respicardia, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023953</manufacturerSrn>
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    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
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    <reference>3203</reference>
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    <lastUpdated>2026-07-05T08:34:02.615Z</lastUpdated>
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    <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>
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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>
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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>
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    <udiDi>00857688007094</udiDi>
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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>
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    <emdnCode>J0206</emdnCode>
    <emdnDescription>FRENIC NERVE IMPLANTABLE NEUROSTIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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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>
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    <emdnDescription>FRENIC NERVE IMPLANTABLE NEUROSTIMULATORS</emdnDescription>
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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>
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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>
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    <tradeName>remede Respistim</tradeName>
    <deviceName>remedē Respistim R Stimulation Lead</deviceName>
    <manufacturerName>ZOLL Respicardia, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023953</manufacturerSrn>
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    <emdnDescription>FRENIC NERVE IMPLANTABLE NEUROSTIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:33:49.787Z</lastUpdated>
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    <udiDi>00857688007001</udiDi>
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    <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>
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    <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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    <udiDi>D-002581LQ</udiDi>
    <basicUdiDi>B-002581LQ</basicUdiDi>
    <tradeName>Evoke®  Clinical Data Viewer</tradeName>
    <deviceName>Evoke®  Clinical Data Viewer</deviceName>
    <manufacturerName>Saluda Medical Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000010522</manufacturerSrn>
    <authorisedRepresentativeName>MedR-AR Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000120</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
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    <emdnCode>J020792</emdnCode>
    <emdnDescription>NEUROSTIMULATORS PROGRAMMERS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>002581</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:06:16.897Z</lastUpdated>
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    <udiDi>D-000897M8</udiDi>
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    <tradeName>Evoke® Firmware Upgrade Application (FUA)</tradeName>
    <deviceName>Evoke® Firmware Upgrade Application (FUA)</deviceName>
    <manufacturerName>Saluda Medical Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000010522</manufacturerSrn>
    <authorisedRepresentativeName>MedR-AR Services B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:10:36.233Z</lastUpdated>
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    <udiDi>D-000870LL</udiDi>
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    <tradeName>Evoke®  Clinical Programming Application (CPA)</tradeName>
    <deviceName>Evoke® Clinical Programming Application (CPA)</deviceName>
    <manufacturerName>Saluda Medical Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000010522</manufacturerSrn>
    <authorisedRepresentativeName>MedR-AR Services B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:10:34.638Z</lastUpdated>
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    <deviceName>Training Software For Visual Function Therapy</deviceName>
    <manufacturerName>Guangzhou Shijing Medical Software Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032261</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <deviceName>Training Software For Visual Function Therapy</deviceName>
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    <manufacturerName>Motron NV</manufacturerName>
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    <tradeName>Test Stimulator</tradeName>
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    <manufacturerName>Beijing PINS Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022865</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>T901</reference>
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