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<eudamedExport entity="devices">
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    <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>01.57.471972</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:09:13.823Z</lastUpdated>
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    <udiDi>06944413810990</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>01.57.471971</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:09:13.039Z</lastUpdated>
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    <udiDi>06944413810945</udiDi>
    <basicUdiDi>69444138XSGP</basicUdiDi>
    <tradeName>Patient Monitor</tradeName>
    <deviceName>Patient Monitor</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>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>X12</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:09:12.390Z</lastUpdated>
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    <udiDi>06944413810921</udiDi>
    <basicUdiDi>69444138XSGP</basicUdiDi>
    <tradeName>Patient Monitor</tradeName>
    <deviceName>Patient Monitor</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>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>X10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:09:08.428Z</lastUpdated>
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  <row>
    <udiDi>06944413810013</udiDi>
    <basicUdiDi>B-06944413810013</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>2026-06-27T09:09:06.102Z</lastUpdated>
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  <row>
    <udiDi>06944413809963</udiDi>
    <basicUdiDi>B-06944413809963</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>2026-06-27T09:09:02.239Z</lastUpdated>
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  <row>
    <udiDi>06944413810846</udiDi>
    <basicUdiDi>69444138SSG8</basicUdiDi>
    <tradeName>SpO2 sensor</tradeName>
    <deviceName>SpO2 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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020280</emdnCode>
    <emdnDescription>MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SH1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:08:47.764Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413810723</udiDi>
    <basicUdiDi>69444138U6022</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>U60</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:08:34.152Z</lastUpdated>
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  <row>
    <udiDi>06944413810020</udiDi>
    <basicUdiDi>B-06944413810020</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>2026-06-27T09:08:28.113Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413809956</udiDi>
    <basicUdiDi>B-06944413809956</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>2026-06-27T09:08:14.114Z</lastUpdated>
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  <row>
    <udiDi>06944413809864</udiDi>
    <basicUdiDi>B-06944413809864</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-BG4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:08:05.079Z</lastUpdated>
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  <row>
    <udiDi>06944413809857</udiDi>
    <basicUdiDi>B-06944413809857</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-BG4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:07:59.516Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413809840</udiDi>
    <basicUdiDi>B-06944413809840</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-BG3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:07:56.512Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413809833</udiDi>
    <basicUdiDi>B-06944413809833</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-BG3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:07:55.245Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413809789</udiDi>
    <basicUdiDi>B-06944413809789</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-BC4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:07:53.342Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413809772</udiDi>
    <basicUdiDi>B-06944413809772</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-BC4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:07:48.249Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413809468</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>01.13.037477</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:07:45.620Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413809239</udiDi>
    <basicUdiDi>69444138C3SYY</basicUdiDi>
    <tradeName>Video Colposcope</tradeName>
    <deviceName>Video Colposcope</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>Z12020703</emdnCode>
    <emdnDescription>COLPOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C600</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:07:44.418Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413809215</udiDi>
    <basicUdiDi>69444138C3SYY</basicUdiDi>
    <tradeName>Video Colposcope</tradeName>
    <deviceName>Video Colposcope</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>Z12020703</emdnCode>
    <emdnDescription>COLPOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C300A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:07:40.822Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413809208</udiDi>
    <basicUdiDi>69444138C3SYY</basicUdiDi>
    <tradeName>Video Colposcope</tradeName>
    <deviceName>Video Colposcope</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>Z12020703</emdnCode>
    <emdnDescription>COLPOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iHC3A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:07:37.490Z</lastUpdated>
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