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<eudamedExport entity="devices">
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    <basicUdiDi>69444138SKS5Q</basicUdiDi>
    <tradeName>EMG/Stimulation sensor</tradeName>
    <deviceName>EMG/Stimulation sensor</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>U070399</emdnCode>
    <emdnDescription>PELVIC FLOOR REHABILITATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SK2020WF-Y</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:35:44.994Z</lastUpdated>
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    <udiDi>06944413834088</udiDi>
    <basicUdiDi>69444138SKS5Q</basicUdiDi>
    <tradeName>EMG/Stimulation sensor</tradeName>
    <deviceName>EMG/Stimulation sensor</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>U070399</emdnCode>
    <emdnDescription>PELVIC FLOOR REHABILITATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SK72156WF-R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:35:41.407Z</lastUpdated>
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    <udiDi>06944413834026</udiDi>
    <basicUdiDi>69444138SKS5Q</basicUdiDi>
    <tradeName>EMG/Stimulation sensor</tradeName>
    <deviceName>EMG/Stimulation sensor</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>U070399</emdnCode>
    <emdnDescription>PELVIC FLOOR REHABILITATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SK6090WF-F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:35:40.199Z</lastUpdated>
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    <udiDi>06944413833906</udiDi>
    <basicUdiDi>69444138ConCableBK</basicUdiDi>
    <tradeName>Connection Cable</tradeName>
    <deviceName>Connection 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>Z12030280</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iM3s SpO2-TEMP-09</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:35:37.799Z</lastUpdated>
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    <udiDi>06944413833401</udiDi>
    <basicUdiDi>B-06944413833401</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>MicroSample-BG10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:35:32.989Z</lastUpdated>
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    <udiDi>06944413833395</udiDi>
    <basicUdiDi>B-06944413833395</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>MicroSample-BG10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:35:30.692Z</lastUpdated>
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    <udiDi>06944413833388</udiDi>
    <basicUdiDi>B-06944413833388</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>MicroSample-BG10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:35:29.863Z</lastUpdated>
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  <row>
    <udiDi>06944413833371</udiDi>
    <basicUdiDi>B-06944413833371</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>MicroSample-BG10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:35:25.790Z</lastUpdated>
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    <udiDi>06944413833364</udiDi>
    <basicUdiDi>B-06944413833364</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>MicroSample-BG10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:35:22.189Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413833357</udiDi>
    <basicUdiDi>B-06944413833357</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>MicroSample-BG10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:35:19.782Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413833340</udiDi>
    <basicUdiDi>B-06944413833340</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>MicroSample-BG10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:35:18.671Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413833333</udiDi>
    <basicUdiDi>B-06944413833333</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>MicroSample-BG10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:35:15.072Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413833326</udiDi>
    <basicUdiDi>B-06944413833326</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>MicroSample-BG10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:35:10.209Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413833319</udiDi>
    <basicUdiDi>B-06944413833319</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>MicroSample-BG10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:35:07.772Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413832985</udiDi>
    <basicUdiDi>B-06944413832985</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>2026-06-27T09:35:07.114Z</lastUpdated>
  </row>
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    <udiDi>06944413832978</udiDi>
    <basicUdiDi>B-06944413832978</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>MicroSample-BG8</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:35:02.976Z</lastUpdated>
  </row>
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    <udiDi>06944413832961</udiDi>
    <basicUdiDi>B-06944413832961</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>MicroSample-BG8</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:34:58.172Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413832954</udiDi>
    <basicUdiDi>B-06944413832954</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>MicroSample-BG8</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:34:55.781Z</lastUpdated>
  </row>
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    <udiDi>06944413832947</udiDi>
    <basicUdiDi>B-06944413832947</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>MicroSample-BG8</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:34:54.857Z</lastUpdated>
  </row>
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    <udiDi>06944413832930</udiDi>
    <basicUdiDi>B-06944413832930</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>MicroSample-BG8</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:34:52.172Z</lastUpdated>
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</eudamedExport>