<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-109-0014-004SS</udiDi>
    <basicUdiDi>B-109-0014-004SS</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>109-0014-004</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:43:52.974Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0014-003SQ</udiDi>
    <basicUdiDi>B-109-0014-003SQ</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>109-0014-003</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:43:48.940Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0014-002SN</udiDi>
    <basicUdiDi>B-109-0014-002SN</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>109-0014-002</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:43:47.338Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0014-001SL</udiDi>
    <basicUdiDi>B-109-0014-001SL</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>109-0014-001</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:43:46.543Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0013-001S9</udiDi>
    <basicUdiDi>B-109-0013-001S9</basicUdiDi>
    <tradeName>iCLAS™ Cryoablation Catheter</tradeName>
    <deviceName>iCLAS™ Cryoablation Catheter</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>MDD</legislation>
    <emdnCode>C020302</emdnCode>
    <emdnDescription>ARRHYTHMOGENIC FOCI CRYOENERGY ABLATION CATHETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0013-001</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:43:45.751Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944414068895</udiDi>
    <basicUdiDi>69444140015SR</basicUdiDi>
    <tradeName>Disposable Defibrillation Electrodes</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Med-link Electronics Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011145</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020401</emdnCode>
    <emdnDescription>EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DE0005A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:08:10.087Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944414068956</udiDi>
    <basicUdiDi>69444140005SN</basicUdiDi>
    <tradeName>ECG Electrode</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Med-link Electronics Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011145</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020501</emdnCode>
    <emdnDescription>ECG ELECTRODES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V0014A-RT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:08:10.056Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944414068970</udiDi>
    <basicUdiDi>69444140005SN</basicUdiDi>
    <tradeName>ECG Electrode</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Med-link Electronics Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011145</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020501</emdnCode>
    <emdnDescription>ECG ELECTRODES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V0014-C0403A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:08:10.042Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944414068987</udiDi>
    <basicUdiDi>69444140005SN</basicUdiDi>
    <tradeName>ECG Electrode</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Med-link Electronics Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011145</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020501</emdnCode>
    <emdnDescription>ECG ELECTRODES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V0014-C0403I</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:08:10.026Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944414068994</udiDi>
    <basicUdiDi>69444140005SN</basicUdiDi>
    <tradeName>ECG Electrode</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Med-link Electronics Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011145</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020501</emdnCode>
    <emdnDescription>ECG ELECTRODES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V0014-C0403I</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:08:10.000Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944414069007</udiDi>
    <basicUdiDi>69444140005SN</basicUdiDi>
    <tradeName>ECG Electrode</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Med-link Electronics Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011145</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020501</emdnCode>
    <emdnDescription>ECG ELECTRODES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V0014-C0403I</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:08:09.980Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944414069014</udiDi>
    <basicUdiDi>69444140005SN</basicUdiDi>
    <tradeName>ECG Electrode</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Med-link Electronics Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011145</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020501</emdnCode>
    <emdnDescription>ECG ELECTRODES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V0014C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:08:09.960Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944414069076</udiDi>
    <basicUdiDi>69444140005SN</basicUdiDi>
    <tradeName>ECG Electrode</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Med-link Electronics Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011145</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020501</emdnCode>
    <emdnDescription>ECG ELECTRODES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V0014C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:08:09.904Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944414071659</udiDi>
    <basicUdiDi>69444140015SR</basicUdiDi>
    <tradeName>Disposable Defibrillation Electrodes</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Med-link Electronics Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011145</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020401</emdnCode>
    <emdnDescription>EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DE0001A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:08:09.338Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944414071895</udiDi>
    <basicUdiDi>69444140005SN</basicUdiDi>
    <tradeName>ECG Electrode</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Med-link Electronics Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011145</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020501</emdnCode>
    <emdnDescription>ECG ELECTRODES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V0014-C0405I</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:08:09.202Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944414072557</udiDi>
    <basicUdiDi>69444140005SN</basicUdiDi>
    <tradeName>ECG Electrode</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Med-link Electronics Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011145</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020501</emdnCode>
    <emdnDescription>ECG ELECTRODES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V0014A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:08:08.995Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944414072717</udiDi>
    <basicUdiDi>69444140015SR</basicUdiDi>
    <tradeName>Disposable Defibrillation Electrodes</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Med-link Electronics Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011145</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020401</emdnCode>
    <emdnDescription>EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DE0003A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:07:46.643Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944414072922</udiDi>
    <basicUdiDi>69444140015SR</basicUdiDi>
    <tradeName>Disposable Defibrillation Electrodes</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Med-link Electronics Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011145</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020401</emdnCode>
    <emdnDescription>EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DE0005A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:07:46.530Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944414073363</udiDi>
    <basicUdiDi>69444140005SN</basicUdiDi>
    <tradeName>ECG Electrode</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Med-link Electronics Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011145</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020501</emdnCode>
    <emdnDescription>ECG ELECTRODES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V0014A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:07:46.427Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944414073530</udiDi>
    <basicUdiDi>69444140005SN</basicUdiDi>
    <tradeName>ECG Electrode</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Med-link Electronics Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011145</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020501</emdnCode>
    <emdnDescription>ECG ELECTRODES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V0014-C0405I</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:07:46.395Z</lastUpdated>
  </row>
</eudamedExport>