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    <tradeName>08809435481215</tradeName>
    <deviceName>Defibrillation Electrode</deviceName>
    <manufacturerName>CU Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000018333</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020401</emdnCode>
    <emdnDescription>EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CUA1904S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:06:58.664Z</lastUpdated>
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    <udiDi>08809435481048</udiDi>
    <basicUdiDi>B-08809435481048</basicUdiDi>
    <tradeName>08809435481048</tradeName>
    <deviceName>Pediatric Defibrillation Electrode</deviceName>
    <manufacturerName>CU Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000018333</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020401</emdnCode>
    <emdnDescription>EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CUA1102S</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:06:53.845Z</lastUpdated>
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    <udiDi>08809435481031</udiDi>
    <basicUdiDi>B-08809435481031</basicUdiDi>
    <tradeName>08809435481031</tradeName>
    <deviceName>Defibrillation Electrode</deviceName>
    <manufacturerName>CU Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000018333</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020401</emdnCode>
    <emdnDescription>EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CUA1007S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:06:52.253Z</lastUpdated>
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    <udiDi>08809435480096</udiDi>
    <basicUdiDi>B-08809435480096</basicUdiDi>
    <tradeName>08809435480096</tradeName>
    <deviceName>Pediatric Defibrillation Electrode</deviceName>
    <manufacturerName>CU Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000018333</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020401</emdnCode>
    <emdnDescription>EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CUA0711P</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:06:45.841Z</lastUpdated>
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    <udiDi>08809434320188</udiDi>
    <basicUdiDi>B-08809434320188</basicUdiDi>
    <tradeName>Heart Guardian</tradeName>
    <deviceName>Automated External Defibrillator</deviceName>
    <manufacturerName>RADIANQBIO</manufacturerName>
    <manufacturerSrn>KR-MF-000013678</manufacturerSrn>
    <authorisedRepresentativeName>S.B. Pharma GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005392</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020480</emdnCode>
    <emdnDescription>CARDIOVERSION AND EXTERNAL DEFIBRILLATION DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Heart Guardian HR-701 Plus B</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:06:43.434Z</lastUpdated>
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    <udiDi>08809434320225</udiDi>
    <basicUdiDi>B-08809434320225</basicUdiDi>
    <tradeName>P-701</tradeName>
    <deviceName>EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS</deviceName>
    <manufacturerName>RADIANQBIO</manufacturerName>
    <manufacturerSrn>KR-MF-000013678</manufacturerSrn>
    <authorisedRepresentativeName>S.B. Pharma GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005392</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020401</emdnCode>
    <emdnDescription>EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P-701</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:06:40.330Z</lastUpdated>
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    <udiDi>08809434320171</udiDi>
    <basicUdiDi>B-08809434320171</basicUdiDi>
    <tradeName>Heart Guardian</tradeName>
    <deviceName>Automated External Defibrillator</deviceName>
    <manufacturerName>RADIANQBIO</manufacturerName>
    <manufacturerSrn>KR-MF-000013678</manufacturerSrn>
    <authorisedRepresentativeName>S.B. Pharma GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005392</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020480</emdnCode>
    <emdnDescription>CARDIOVERSION AND EXTERNAL DEFIBRILLATION DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Heart Guardian HR-701 Plus A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:06:26.588Z</lastUpdated>
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    <udiDi>08809434320164</udiDi>
    <basicUdiDi>B-08809434320164</basicUdiDi>
    <tradeName>Heart Guardian</tradeName>
    <deviceName>Automated External Defibrillator</deviceName>
    <manufacturerName>RADIANQBIO</manufacturerName>
    <manufacturerSrn>KR-MF-000013678</manufacturerSrn>
    <authorisedRepresentativeName>S.B. Pharma GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005392</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020480</emdnCode>
    <emdnDescription>CARDIOVERSION AND EXTERNAL DEFIBRILLATION DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Heart Guardian HR-701 Plus</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:06:24.181Z</lastUpdated>
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    <udiDi>08809434320157</udiDi>
    <basicUdiDi>B-08809434320157</basicUdiDi>
    <tradeName>Heart Guardian</tradeName>
    <deviceName>Automated External Defibrillator</deviceName>
    <manufacturerName>RADIANQBIO</manufacturerName>
    <manufacturerSrn>KR-MF-000013678</manufacturerSrn>
    <authorisedRepresentativeName>S.B. Pharma GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005392</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020480</emdnCode>
    <emdnDescription>CARDIOVERSION AND EXTERNAL DEFIBRILLATION DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Heart Guardian HR-701 B</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:06:22.578Z</lastUpdated>
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  <row>
    <udiDi>08809434320140</udiDi>
    <basicUdiDi>B-08809434320140</basicUdiDi>
    <tradeName>Heart Guardian</tradeName>
    <deviceName>Automated External Defibrillator</deviceName>
    <manufacturerName>RADIANQBIO</manufacturerName>
    <manufacturerSrn>KR-MF-000013678</manufacturerSrn>
    <authorisedRepresentativeName>S.B. Pharma GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005392</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020480</emdnCode>
    <emdnDescription>CARDIOVERSION AND EXTERNAL DEFIBRILLATION DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Heart Guardian HR-701 A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:06:21.782Z</lastUpdated>
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  <row>
    <udiDi>08809434320133</udiDi>
    <basicUdiDi>B-08809434320133</basicUdiDi>
    <tradeName>Heart Guardian</tradeName>
    <deviceName>Automated External Defibrillator</deviceName>
    <manufacturerName>RADIANQBIO</manufacturerName>
    <manufacturerSrn>KR-MF-000013678</manufacturerSrn>
    <authorisedRepresentativeName>S.B. Pharma GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005392</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020480</emdnCode>
    <emdnDescription>CARDIOVERSION AND EXTERNAL DEFIBRILLATION DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Heart Guardian HR-701</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:06:20.279Z</lastUpdated>
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    <udiDi>08809434320102</udiDi>
    <basicUdiDi>B-08809434320102</basicUdiDi>
    <tradeName>P-303</tradeName>
    <deviceName>EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS</deviceName>
    <manufacturerName>RADIANQBIO</manufacturerName>
    <manufacturerSrn>KR-MF-000013678</manufacturerSrn>
    <authorisedRepresentativeName>S.B. Pharma GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005392</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020401</emdnCode>
    <emdnDescription>EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P-303</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:06:16.985Z</lastUpdated>
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  <row>
    <udiDi>08809434320003</udiDi>
    <basicUdiDi>B-08809434320003</basicUdiDi>
    <tradeName>Heart Guardian</tradeName>
    <deviceName>Automated External Defibrillator</deviceName>
    <manufacturerName>RADIANQBIO</manufacturerName>
    <manufacturerSrn>KR-MF-000013678</manufacturerSrn>
    <authorisedRepresentativeName>S.B. Pharma GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005392</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020480</emdnCode>
    <emdnDescription>CARDIOVERSION AND EXTERNAL DEFIBRILLATION DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Heart Guardian HR-501</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:06:15.381Z</lastUpdated>
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  <row>
    <udiDi>06931377219945</udiDi>
    <basicUdiDi>69313772819V5</basicUdiDi>
    <tradeName>Defibrillation electrode</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Amydi-med Electrics Tech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000013201</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C020401</emdnCode>
    <emdnDescription>EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMD-DD-PF0005-X</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:27:14.335Z</lastUpdated>
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    <udiDi>06931377220163</udiDi>
    <basicUdiDi>69313772819V5</basicUdiDi>
    <tradeName>Defibrillation electrode</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Amydi-med Electrics Tech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000013201</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C020401</emdnCode>
    <emdnDescription>EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMD-DD-AF0002-X</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:27:14.155Z</lastUpdated>
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    <udiDi>06931377220194</udiDi>
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    <tradeName>Defibrillation electrode</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Amydi-med Electrics Tech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000013201</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C020401</emdnCode>
    <emdnDescription>EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMD-DD-AF0013-X</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:27:14.072Z</lastUpdated>
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    <udiDi>06931377220309</udiDi>
    <basicUdiDi>69313772819V5</basicUdiDi>
    <tradeName>Defibrillation electrode</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Amydi-med Electrics Tech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000013201</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C020401</emdnCode>
    <emdnDescription>EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMD-DD-PF0013-X</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:27:13.939Z</lastUpdated>
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    <udiDi>08800009900347</udiDi>
    <basicUdiDi>B-08800009900347</basicUdiDi>
    <tradeName>NT-P38EP</tradeName>
    <deviceName>Electrode Pads</deviceName>
    <manufacturerName>Nanoomtech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000013628</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020401</emdnCode>
    <emdnDescription>EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UA25P104</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:31:57.461Z</lastUpdated>
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    <udiDi>08717931761246</udiDi>
    <basicUdiDi>B-08717931761246</basicUdiDi>
    <tradeName>08717931761246</tradeName>
    <deviceName>CardiAid Electrodes- Pediatric</deviceName>
    <manufacturerName>Cardia International A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000002223</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020401</emdnCode>
    <emdnDescription>EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F/BRO/02</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:46:45.019Z</lastUpdated>
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    <tradeName>08717931761239</tradeName>
    <deviceName>Cardiaid Electrodes- Adult</deviceName>
    <manufacturerName>Cardia International A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000002223</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020401</emdnCode>
    <emdnDescription>EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F/BRO/02</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:46:40.864Z</lastUpdated>
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