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<eudamedExport entity="devices">
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    <udiDi>06944413826755</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>C56 UHD</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:30:14.757Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413826731</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>C9 UHD</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:30:12.842Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413826724</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>C6 UHD</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:30:11.765Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413826717</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>C3 UHD</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:28:13.247Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413826656</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>Z1104020202</emdnCode>
    <emdnDescription>ENDOCAVITARY ULTRASOUND PROBES, MULTIDIMENSIONAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E10-3MQ</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:28:10.442Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413826229</udiDi>
    <basicUdiDi>69444138Trolley201SM4</basicUdiDi>
    <tradeName>Trolley (for medical use)</tradeName>
    <deviceName>Trolley (for medical use)</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>MT-801</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:28:08.038Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413826212</udiDi>
    <basicUdiDi>69444138Trolley201SM4</basicUdiDi>
    <tradeName>Trolley (for medical use)</tradeName>
    <deviceName>Trolley (for medical use)</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>MT-810</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:28:06.839Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413826205</udiDi>
    <basicUdiDi>69444138NIBPTubeMD</basicUdiDi>
    <tradeName>NIBP Tube</tradeName>
    <deviceName>NIBP Tube</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>RPAYACC034</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:28:04.893Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413826199</udiDi>
    <basicUdiDi>69444138ECGCablePWJ</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>Z12030280</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RPAYACC029</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:27:59.657Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413826182</udiDi>
    <basicUdiDi>69444138ECGCablePWJ</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>Z12030280</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RPAYACC010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:27:57.236Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413826175</udiDi>
    <basicUdiDi>69444138ECGCablePWJ</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>Z12030280</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RPAYACC027</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:27:56.040Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413826168</udiDi>
    <basicUdiDi>69444138ECGCablePWJ</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>Z12030280</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RPAYACC008</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:27:52.453Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413826137</udiDi>
    <basicUdiDi>69444138isafeCsCD</basicUdiDi>
    <tradeName>Blood Sampler</tradeName>
    <deviceName>Blood Sampler</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 Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0501010203</emdnCode>
    <emdnDescription>BLOOD COLLECTION, CAPILLARY TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>isafeC-100BN</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:27:48.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413826120</udiDi>
    <basicUdiDi>69444138isafeCsCD</basicUdiDi>
    <tradeName>Blood Sampler</tradeName>
    <deviceName>Blood Sampler</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 Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0501010203</emdnCode>
    <emdnDescription>BLOOD COLLECTION, CAPILLARY TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>isafeC-85AN</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:27:46.445Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413826113</udiDi>
    <basicUdiDi>69444138isafeCsCD</basicUdiDi>
    <tradeName>Blood Sampler</tradeName>
    <deviceName>Blood Sampler</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 Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0501010203</emdnCode>
    <emdnDescription>BLOOD COLLECTION, CAPILLARY TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>isafeC-115BY</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:27:45.229Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413826106</udiDi>
    <basicUdiDi>69444138isafeCsCD</basicUdiDi>
    <tradeName>Blood Sampler</tradeName>
    <deviceName>Blood Sampler</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 Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0501010203</emdnCode>
    <emdnDescription>BLOOD COLLECTION, CAPILLARY TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>isafeC-100AY</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:27:42.926Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413826083</udiDi>
    <basicUdiDi>69444138isafeCsCD</basicUdiDi>
    <tradeName>Blood Sampler</tradeName>
    <deviceName>Blood Sampler</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 Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0501010203</emdnCode>
    <emdnDescription>BLOOD COLLECTION, CAPILLARY TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>isafeC-100BN</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:27:38.032Z</lastUpdated>
  </row>
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    <udiDi>06944413826069</udiDi>
    <basicUdiDi>69444138isafeCsCD</basicUdiDi>
    <tradeName>Blood Sampler</tradeName>
    <deviceName>Blood Sampler</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 Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0501010203</emdnCode>
    <emdnDescription>BLOOD COLLECTION, CAPILLARY TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>isafeC-100BN</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:27:35.636Z</lastUpdated>
  </row>
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    <udiDi>06944413826052</udiDi>
    <basicUdiDi>69444138isafeCsCD</basicUdiDi>
    <tradeName>Blood Sampler</tradeName>
    <deviceName>Blood Sampler</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 Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0501010203</emdnCode>
    <emdnDescription>BLOOD COLLECTION, CAPILLARY TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>isafeC-85AN</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:27:34.433Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413826038</udiDi>
    <basicUdiDi>69444138isafeCsCD</basicUdiDi>
    <tradeName>Blood Sampler</tradeName>
    <deviceName>Blood Sampler</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 Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0501010203</emdnCode>
    <emdnDescription>BLOOD COLLECTION, CAPILLARY TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>isafeC-85AN</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:27:32.034Z</lastUpdated>
  </row>
</eudamedExport>