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<eudamedExport entity="devices">
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    <udiDi>06944413832084</udiDi>
    <basicUdiDi>B-06944413832084</basicUdiDi>
    <tradeName>Test Cartridge</tradeName>
    <deviceName>Test Cartridge</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060605</emdnCode>
    <emdnDescription>BG &amp;/OR ISE &amp;/OR METABOLITES - ELECTRODES (BG)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BG8</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:33:34.885Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413832077</udiDi>
    <basicUdiDi>B-06944413832077</basicUdiDi>
    <tradeName>Test Cartridge</tradeName>
    <deviceName>Test Cartridge</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060605</emdnCode>
    <emdnDescription>BG &amp;/OR ISE &amp;/OR METABOLITES - ELECTRODES (BG)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BG8</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:33:34.064Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413832060</udiDi>
    <basicUdiDi>B-06944413832060</basicUdiDi>
    <tradeName>Test Cartridge</tradeName>
    <deviceName>Test Cartridge</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060605</emdnCode>
    <emdnDescription>BG &amp;/OR ISE &amp;/OR METABOLITES - ELECTRODES (BG)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BG8</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:33:32.460Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413832053</udiDi>
    <basicUdiDi>B-06944413832053</basicUdiDi>
    <tradeName>Test Cartridge</tradeName>
    <deviceName>Test Cartridge</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060605</emdnCode>
    <emdnDescription>BG &amp;/OR ISE &amp;/OR METABOLITES - ELECTRODES (BG)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BG8</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:33:28.667Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413831971</udiDi>
    <basicUdiDi>69444138TPG5</basicUdiDi>
    <tradeName>Temperature Probe</tradeName>
    <deviceName>Temperature Probe</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V03010201</emdnCode>
    <emdnDescription>TEMPERATURE MONITORING CUTANEOUS PROBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TP2NS10R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:33:18.760Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413831964</udiDi>
    <basicUdiDi>69444138TPG5</basicUdiDi>
    <tradeName>Temperature Probe</tradeName>
    <deviceName>Temperature Probe</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V03010201</emdnCode>
    <emdnDescription>TEMPERATURE MONITORING CUTANEOUS PROBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TP2NS2R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:33:18.167Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413831957</udiDi>
    <basicUdiDi>69444138TPG5</basicUdiDi>
    <tradeName>Temperature Probe</tradeName>
    <deviceName>Temperature Probe</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V03010201</emdnCode>
    <emdnDescription>TEMPERATURE MONITORING CUTANEOUS PROBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TP2AS10R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:33:17.922Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413831889</udiDi>
    <basicUdiDi>69444138SE3012SFV</basicUdiDi>
    <tradeName>Holter System</tradeName>
    <deviceName>Holter System</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iSE-3012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:33:08.894Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413831834</udiDi>
    <basicUdiDi>69444138SE3012SFV</basicUdiDi>
    <tradeName>Holter System</tradeName>
    <deviceName>Holter System</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SE-3012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:33:07.260Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413831797</udiDi>
    <basicUdiDi>69444138UTGG</basicUdiDi>
    <tradeName>ultrasonic transducer</tradeName>
    <deviceName>ultrasonic transducer</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110402010201</emdnCode>
    <emdnDescription>CURVILINEAR TRANSCUTANEOUS TWO–DIMENSIONAL ULTRASOUND PROBES  (CONVEX–ARRAY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C5-1XQ</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:33:06.565Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413831636</udiDi>
    <basicUdiDi>69444138TPG5</basicUdiDi>
    <tradeName>Temperature Probe</tradeName>
    <deviceName>Temperature Probe</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V03010201</emdnCode>
    <emdnDescription>TEMPERATURE MONITORING CUTANEOUS PROBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TP2AS2R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:33:03.586Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413831612</udiDi>
    <basicUdiDi>69444138NanoS8P</basicUdiDi>
    <tradeName>Diagnostic Ultrasound System</tradeName>
    <deviceName>Diagnostic Ultrasound System</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040101</emdnCode>
    <emdnDescription>INTERNAL ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Nano L12</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:32:58.273Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413831605</udiDi>
    <basicUdiDi>69444138NanoS8P</basicUdiDi>
    <tradeName>Diagnostic Ultrasound System</tradeName>
    <deviceName>Diagnostic Ultrasound System</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040101</emdnCode>
    <emdnDescription>INTERNAL ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Nano C5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:32:57.365Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413831438</udiDi>
    <basicUdiDi>69444138ECGCableEVU</basicUdiDi>
    <tradeName>ECG Cable</tradeName>
    <deviceName>ECG Cable</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050380</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EC10DABHD1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:32:57.187Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413831421</udiDi>
    <basicUdiDi>69444138ECGCableEVU</basicUdiDi>
    <tradeName>ECG Cable</tradeName>
    <deviceName>ECG Cable</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050380</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EC10DIBHD1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:32:46.638Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413831414</udiDi>
    <basicUdiDi>69444138ECGCableEVU</basicUdiDi>
    <tradeName>ECG Cable</tradeName>
    <deviceName>ECG Cable</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050380</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EC05DASHD1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:32:41.276Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413831407</udiDi>
    <basicUdiDi>69444138ECGCableEVU</basicUdiDi>
    <tradeName>ECG Cable</tradeName>
    <deviceName>ECG Cable</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050380</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EC05DISHD1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:32:39.037Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413831391</udiDi>
    <basicUdiDi>69444138ECGCableEVU</basicUdiDi>
    <tradeName>ECG Cable</tradeName>
    <deviceName>ECG Cable</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050380</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EC07DASHD1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:32:37.990Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413831384</udiDi>
    <basicUdiDi>69444138ECGCableEVU</basicUdiDi>
    <tradeName>ECG Cable</tradeName>
    <deviceName>ECG Cable</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050380</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EC07DISHD1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:32:35.274Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413831377</udiDi>
    <basicUdiDi>69444138ECGCableEVU</basicUdiDi>
    <tradeName>ECG Cable</tradeName>
    <deviceName>ECG Cable</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050380</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EC10DASHD1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:32:30.460Z</lastUpdated>
  </row>
</eudamedExport>