<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-109-0004-001S7</udiDi>
    <basicUdiDi>B-109-0004-001S7</basicUdiDi>
    <tradeName>Esophageal Warming Balloon Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Adagio Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001129</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0004-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:26.793Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0013-001S9</udiDi>
    <basicUdiDi>B-109-0013-001S9</basicUdiDi>
    <tradeName>iCLAS™ Cryoablation Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Adagio Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001129</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0013-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:26.771Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0014-001SL</udiDi>
    <basicUdiDi>B-109-0014-001SL</basicUdiDi>
    <tradeName>iCLAS™ Shaped Stylet Accesory</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0014-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:26.749Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0014-002SN</udiDi>
    <basicUdiDi>B-109-0014-002SN</basicUdiDi>
    <tradeName>iCLAS™ Shaped Stylet Accesory</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0014-002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:26.730Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0014-003SQ</udiDi>
    <basicUdiDi>B-109-0014-003SQ</basicUdiDi>
    <tradeName>iCLAS™ Shaped Stylet Accesory</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0014-003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:26.713Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0014-004SS</udiDi>
    <basicUdiDi>B-109-0014-004SS</basicUdiDi>
    <tradeName>iCLAS™ Shaped Stylet Accesory</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0014-004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:26.694Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0014-005SU</udiDi>
    <basicUdiDi>B-109-0014-005SU</basicUdiDi>
    <tradeName>iCLAS™ Shaped Stylet Accesory</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0014-005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:26.676Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0014-006SW</udiDi>
    <basicUdiDi>B-109-0014-006SW</basicUdiDi>
    <tradeName>iCLAS™ Shaped Stylet Accesory</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0014-006</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:26.658Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0014-007SY</udiDi>
    <basicUdiDi>B-109-0014-007SY</basicUdiDi>
    <tradeName>iCLAS™ Shaped Stylet Accesory</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0014-007</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:26.640Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0014-008T2</udiDi>
    <basicUdiDi>B-109-0014-008T2</basicUdiDi>
    <tradeName>iCLAS™ Shaped Stylet Accesory</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0014-008</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:26.623Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0014-009T4</udiDi>
    <basicUdiDi>B-109-0014-009T4</basicUdiDi>
    <tradeName>iCLAS™ Shaped Stylet Accesory</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0014-009</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:26.602Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0014-010SM</udiDi>
    <basicUdiDi>B-109-0014-010SM</basicUdiDi>
    <tradeName>Adagio iCLAS™ Shaped Stylets</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0014-010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:26.583Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0014-011SP</udiDi>
    <basicUdiDi>B-109-0014-011SP</basicUdiDi>
    <tradeName>iCLAS™ Shaped Stylet Accesory</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0014-011</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:26.567Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0014-012SR</udiDi>
    <basicUdiDi>B-109-0014-012SR</basicUdiDi>
    <tradeName>iCLAS™ Shaped Stylet Accesory</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0014-012</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:26.551Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0014-013ST</udiDi>
    <basicUdiDi>B-109-0014-013ST</basicUdiDi>
    <tradeName>iCLAS™ Shaped Stylet Accesory</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0014-013</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:26.532Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0014-014SV</udiDi>
    <basicUdiDi>B-109-0014-014SV</basicUdiDi>
    <tradeName>iCLAS™ Shaped Stylet Accesory</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0014-014</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:26.513Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0014-015SX</udiDi>
    <basicUdiDi>B-109-0014-015SX</basicUdiDi>
    <tradeName>iCLAS™ Shaped Stylet Accesory</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0014-015</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:26.492Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0014-016SZ</udiDi>
    <basicUdiDi>B-109-0014-016SZ</basicUdiDi>
    <tradeName>iCLAS™ Shaped Stylet Accesory</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0014-016</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:26.474Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0014-017T3</udiDi>
    <basicUdiDi>B-109-0014-017T3</basicUdiDi>
    <tradeName>iCLAS™ Shaped Stylet Accesory</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0014-017</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:26.459Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0014-018T5</udiDi>
    <basicUdiDi>B-109-0014-018T5</basicUdiDi>
    <tradeName>iCLAS™ Shaped Stylet Accesory</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0014-018</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:26.447Z</lastUpdated>
  </row>
</eudamedExport>