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<eudamedExport entity="devices">
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    <udiDi>08714729992769</udiDi>
    <basicUdiDi>01915060000000000000406MY</basicUdiDi>
    <tradeName>SMARTFREEZE™</tradeName>
    <deviceName>SMARTFREEZE Catheter Extension Cable</deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020380</emdnCode>
    <emdnDescription>ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M004CRBS5100</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:10:06.072Z</lastUpdated>
  </row>
  <row>
    <udiDi>08714729992745</udiDi>
    <basicUdiDi>01915060000000000000403MS</basicUdiDi>
    <tradeName>SMARTFREEZE™</tradeName>
    <deviceName>SMARTFREEZE Foot Switch</deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020380</emdnCode>
    <emdnDescription>ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M004CRBS4200</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:10:05.256Z</lastUpdated>
  </row>
  <row>
    <udiDi>00191506013523</udiDi>
    <basicUdiDi>01915060000000000000299NP</basicUdiDi>
    <tradeName>SMARTFREEZE™</tradeName>
    <deviceName>SMARTFREEZE Cryo-Console Accessories</deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020380</emdnCode>
    <emdnDescription>ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M004CRBS6600</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:54:56.496Z</lastUpdated>
  </row>
  <row>
    <udiDi>00191506007737</udiDi>
    <basicUdiDi>01915060000000000000237MZ</basicUdiDi>
    <tradeName>SMARTFREEZE™</tradeName>
    <deviceName>SMARTFREEZE Cryo-Console</deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020380</emdnCode>
    <emdnDescription>ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M004CRBS6500</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:54:50.138Z</lastUpdated>
  </row>
  <row>
    <udiDi>00191506007522</udiDi>
    <basicUdiDi>01915060000000000000212MH</basicUdiDi>
    <tradeName>SMARTFREEZE™</tradeName>
    <deviceName>SMARTFREEZE CRYO Console Accessories</deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020380</emdnCode>
    <emdnDescription>ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M004CRBS6320</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:54:49.251Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0014-023SW</udiDi>
    <basicUdiDi>B-109-0014-023SW</basicUdiDi>
    <tradeName>iCLAS™ Shaped Stylet Accesory</tradeName>
    <deviceName>iCLAS™ Shaped Stylet Accessory</deviceName>
    <manufacturerName>Adagio Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001129</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020380</emdnCode>
    <emdnDescription>ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0014-023</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:44:40.270Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0014-022SU</udiDi>
    <basicUdiDi>B-109-0014-022SU</basicUdiDi>
    <tradeName>iCLAS™ Shaped Stylet Accesory</tradeName>
    <deviceName>iCLAS™ Shaped Stylet Accessory</deviceName>
    <manufacturerName>Adagio Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001129</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020380</emdnCode>
    <emdnDescription>ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0014-022</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:44:37.820Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0014-021SS</udiDi>
    <basicUdiDi>B-109-0014-021SS</basicUdiDi>
    <tradeName>iCLAS™ Shaped Stylet Accesory</tradeName>
    <deviceName>iCLAS™ Shaped Stylet Accessory</deviceName>
    <manufacturerName>Adagio Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001129</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020380</emdnCode>
    <emdnDescription>ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0014-021</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:44:35.424Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0014-020SQ</udiDi>
    <basicUdiDi>B-109-0014-020SQ</basicUdiDi>
    <tradeName>iCLAS™ Shaped Stylet Accesory</tradeName>
    <deviceName>iCLAS™ Shaped Stylet Accessory</deviceName>
    <manufacturerName>Adagio Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001129</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020380</emdnCode>
    <emdnDescription>ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0014-020</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:44:34.629Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0014-019T7</udiDi>
    <basicUdiDi>B-109-0014-019T7</basicUdiDi>
    <tradeName>iCLAS™ Shaped Stylet Accesory</tradeName>
    <deviceName>iCLAS™ Shaped Stylet Accessory</deviceName>
    <manufacturerName>Adagio Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001129</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020380</emdnCode>
    <emdnDescription>ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0014-019</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:44:33.028Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0014-018T5</udiDi>
    <basicUdiDi>B-109-0014-018T5</basicUdiDi>
    <tradeName>iCLAS™ Shaped Stylet Accesory</tradeName>
    <deviceName>iCLAS™ Shaped Stylet Accessory</deviceName>
    <manufacturerName>Adagio Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001129</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020380</emdnCode>
    <emdnDescription>ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0014-018</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:44:29.817Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0014-017T3</udiDi>
    <basicUdiDi>B-109-0014-017T3</basicUdiDi>
    <tradeName>iCLAS™ Shaped Stylet Accesory</tradeName>
    <deviceName>iCLAS™ Shaped Stylet Accessory</deviceName>
    <manufacturerName>Adagio Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001129</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020380</emdnCode>
    <emdnDescription>ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0014-017</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:44:28.228Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0014-016SZ</udiDi>
    <basicUdiDi>B-109-0014-016SZ</basicUdiDi>
    <tradeName>iCLAS™ Shaped Stylet Accesory</tradeName>
    <deviceName>iCLAS™ Shaped Stylet Accessory</deviceName>
    <manufacturerName>Adagio Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001129</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020380</emdnCode>
    <emdnDescription>ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0014-016</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:44:27.422Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0014-014SV</udiDi>
    <basicUdiDi>B-109-0014-014SV</basicUdiDi>
    <tradeName>iCLAS™ Shaped Stylet Accesory</tradeName>
    <deviceName>iCLAS™ Shaped Stylet Accessory</deviceName>
    <manufacturerName>Adagio Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001129</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020380</emdnCode>
    <emdnDescription>ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0014-014</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:44:25.033Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0014-015SX</udiDi>
    <basicUdiDi>B-109-0014-015SX</basicUdiDi>
    <tradeName>iCLAS™ Shaped Stylet Accesory</tradeName>
    <deviceName>iCLAS™ Shaped Stylet Accessory</deviceName>
    <manufacturerName>Adagio Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001129</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020380</emdnCode>
    <emdnDescription>ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0014-015</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:44:22.739Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0014-013ST</udiDi>
    <basicUdiDi>B-109-0014-013ST</basicUdiDi>
    <tradeName>iCLAS™ Shaped Stylet Accesory</tradeName>
    <deviceName>iCLAS™ Shaped Stylet Accessory</deviceName>
    <manufacturerName>Adagio Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001129</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020380</emdnCode>
    <emdnDescription>ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0014-013</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:44:08.960Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0014-012SR</udiDi>
    <basicUdiDi>B-109-0014-012SR</basicUdiDi>
    <tradeName>iCLAS™ Shaped Stylet Accesory</tradeName>
    <deviceName>iCLAS™ Shaped Stylet Accessory</deviceName>
    <manufacturerName>Adagio Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001129</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020380</emdnCode>
    <emdnDescription>ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0014-012</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:44:08.157Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0014-011SP</udiDi>
    <basicUdiDi>B-109-0014-011SP</basicUdiDi>
    <tradeName>iCLAS™ Shaped Stylet Accesory</tradeName>
    <deviceName>iCLAS™ Shaped Stylet Accessory</deviceName>
    <manufacturerName>Adagio Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001129</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020380</emdnCode>
    <emdnDescription>ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0014-011</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:44:03.356Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0014-010SM</udiDi>
    <basicUdiDi>B-109-0014-010SM</basicUdiDi>
    <tradeName>Adagio iCLAS™ Shaped Stylets</tradeName>
    <deviceName>iCLAS™ Shaped Stylet Accessory</deviceName>
    <manufacturerName>Adagio Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001129</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020380</emdnCode>
    <emdnDescription>ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0014-010</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:44:02.561Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0014-009T4</udiDi>
    <basicUdiDi>B-109-0014-009T4</basicUdiDi>
    <tradeName>iCLAS™ Shaped Stylet Accesory</tradeName>
    <deviceName>iCLAS™ Shaped Stylet Accessory</deviceName>
    <manufacturerName>Adagio Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001129</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020380</emdnCode>
    <emdnDescription>ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0014-009</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:44:01.753Z</lastUpdated>
  </row>
</eudamedExport>