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<eudamedExport entity="devices">
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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>
    <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>
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    <udiDi>00857688007117</udiDi>
    <basicUdiDi>B-00857688007117</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>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>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0206</emdnCode>
    <emdnDescription>FRENIC NERVE IMPLANTABLE NEUROSTIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3106</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <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>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0206</emdnCode>
    <emdnDescription>FRENIC NERVE IMPLANTABLE NEUROSTIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3105</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:33:56.196Z</lastUpdated>
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  <row>
    <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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  <row>
    <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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  <row>
    <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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  <row>
    <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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  <row>
    <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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  <row>
    <udiDi>00857068006167</udiDi>
    <basicUdiDi>B-00857068006167</basicUdiDi>
    <tradeName>RejuvenAir</tradeName>
    <deviceName>RejuvenAir System - Console</deviceName>
    <manufacturerName>CSA Medical</manufacturerName>
    <manufacturerSrn>US-MF-000026367</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R0799</emdnCode>
    <emdnDescription>BRONCOPULMONARY ENDOSCOPY DEVICES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>20-00190</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:33:15.330Z</lastUpdated>
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  <row>
    <udiDi>00850045508005</udiDi>
    <basicUdiDi>B-00850045508005</basicUdiDi>
    <tradeName>00850045508005</tradeName>
    <deviceName>SigmaStim Σigma 200J</deviceName>
    <manufacturerName>SigmaStim Domestic LLC</manufacturerName>
    <manufacturerSrn>US-MF-000029359</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12109002</emdnCode>
    <emdnDescription>ELECTROCONVULSIVE THERAPY (ECT) EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9438-5001</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:03:08.120Z</lastUpdated>
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  <row>
    <udiDi>00810087180126</udiDi>
    <basicUdiDi>B-00810087180126</basicUdiDi>
    <tradeName>FARASTAR</tradeName>
    <deviceName>FARASTAR Pulsed Field Ablation Generator</deviceName>
    <manufacturerName>Farapulse Inc</manufacturerName>
    <manufacturerSrn>US-MF-000017969</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120101</emdnCode>
    <emdnDescription>ARTERIOTOMY ABLATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>61M401</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:02:40.637Z</lastUpdated>
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  <row>
    <udiDi>00810087180119</udiDi>
    <basicUdiDi>B-00810087180119</basicUdiDi>
    <tradeName>FARASTAR</tradeName>
    <deviceName>FARASTAR Catheter Connection Cable</deviceName>
    <manufacturerName>Farapulse Inc</manufacturerName>
    <manufacturerSrn>US-MF-000017969</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020304</emdnCode>
    <emdnDescription>ARRHYTHMOGENIC FOCI PULSED FIELD ABLATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>41M404</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:02:39.818Z</lastUpdated>
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  <row>
    <udiDi>00810087180102</udiDi>
    <basicUdiDi>B-00810087180102</basicUdiDi>
    <tradeName>FARAWAVE™</tradeName>
    <deviceName>FARAWAVE Pulsed Field Ablation Catheter, 35mm</deviceName>
    <manufacturerName>Farapulse Inc</manufacturerName>
    <manufacturerSrn>US-MF-000017969</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020304</emdnCode>
    <emdnDescription>ARRHYTHMOGENIC FOCI PULSED FIELD ABLATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>41M402</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:02:39.015Z</lastUpdated>
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  <row>
    <udiDi>00810087180096</udiDi>
    <basicUdiDi>B-00810087180096</basicUdiDi>
    <tradeName>FARAWAVE™</tradeName>
    <deviceName>FARAWAVE Pulsed Field Ablation Catheter, 31mm</deviceName>
    <manufacturerName>Farapulse Inc</manufacturerName>
    <manufacturerSrn>US-MF-000017969</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020304</emdnCode>
    <emdnDescription>ARRHYTHMOGENIC FOCI PULSED FIELD ABLATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>41M401</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:02:38.223Z</lastUpdated>
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    <udiDi>00810087180072</udiDi>
    <basicUdiDi>B-00810087180072</basicUdiDi>
    <tradeName>FARADRIVE™</tradeName>
    <deviceName>FARADRIVE Steerable Sheath (clear)</deviceName>
    <manufacturerName>Farapulse Inc</manufacturerName>
    <manufacturerSrn>US-MF-000017969</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21M402</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:02:22.961Z</lastUpdated>
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    <udiDi>00810008950128</udiDi>
    <basicUdiDi>B-00810008950128</basicUdiDi>
    <tradeName>Paradise™</tradeName>
    <deviceName>Paradise Generator with Paradise Remote</deviceName>
    <manufacturerName>ReCor Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027816</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z129099</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRDS-USG-2X</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:44:46.647Z</lastUpdated>
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    <udiDi>00810008950111</udiDi>
    <basicUdiDi>B-00810008950111</basicUdiDi>
    <tradeName>Paradise™</tradeName>
    <deviceName>Paradise Generator</deviceName>
    <manufacturerName>ReCor Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027816</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z129099</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRDS-USG-2X</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:44:42.643Z</lastUpdated>
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    <udiDi>00810008950074</udiDi>
    <basicUdiDi>B-00810008950074</basicUdiDi>
    <tradeName>Paradise™</tradeName>
    <deviceName>Paradise Cartridge</deviceName>
    <manufacturerName>ReCor Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027816</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K02050103</emdnCode>
    <emdnDescription>COMBINED RADIOFREQUENCY / ULTRASOUND SURGERY INSTRUMENT KITS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRDS-CT-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:44:41.836Z</lastUpdated>
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    <udiDi>00810008950067</udiDi>
    <basicUdiDi>B-00810008950067</basicUdiDi>
    <tradeName>Paradise™</tradeName>
    <deviceName>Paradise Catheter 3.5mm</deviceName>
    <manufacturerName>ReCor Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027816</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K02050109</emdnCode>
    <emdnDescription>COMBINED RADIOFREQUENCY / ULTRASONIC SURGERY HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRDS-063-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:44:41.038Z</lastUpdated>
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