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<eudamedExport entity="devices">
  <row>
    <udiDi>06945868603533</udiDi>
    <basicUdiDi>69458686HD-400M3</basicUdiDi>
    <tradeName>HD-400S</tradeName>
    <deviceName>Image Processor</deviceName>
    <manufacturerName>SONOSCAPE MEDICAL CORP.</manufacturerName>
    <manufacturerSrn>CN-MF-000009623</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020401</emdnCode>
    <emdnDescription>INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:00:45.615Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945868603526</udiDi>
    <basicUdiDi>69458686HD-400M3</basicUdiDi>
    <tradeName>HD-400Pro</tradeName>
    <deviceName>Image Processor</deviceName>
    <manufacturerName>SONOSCAPE MEDICAL CORP.</manufacturerName>
    <manufacturerSrn>CN-MF-000009623</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020401</emdnCode>
    <emdnDescription>INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:00:44.415Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945868603519</udiDi>
    <basicUdiDi>69458686HD-400M3</basicUdiDi>
    <tradeName>HD-400</tradeName>
    <deviceName>Image Processor</deviceName>
    <manufacturerName>SONOSCAPE MEDICAL CORP.</manufacturerName>
    <manufacturerSrn>CN-MF-000009623</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020401</emdnCode>
    <emdnDescription>INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:00:38.407Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945868603502</udiDi>
    <basicUdiDi>69458686HD-400M3</basicUdiDi>
    <tradeName>HD-400Exp</tradeName>
    <deviceName>Image Processor</deviceName>
    <manufacturerName>SONOSCAPE MEDICAL CORP.</manufacturerName>
    <manufacturerSrn>CN-MF-000009623</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020401</emdnCode>
    <emdnDescription>INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:00:37.550Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945868603496</udiDi>
    <basicUdiDi>69458686HD-350MD</basicUdiDi>
    <tradeName>HD-320Plus</tradeName>
    <deviceName>Image Processor</deviceName>
    <manufacturerName>SONOSCAPE MEDICAL CORP.</manufacturerName>
    <manufacturerSrn>CN-MF-000009623</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020401</emdnCode>
    <emdnDescription>INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:00:36.006Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945868603489</udiDi>
    <basicUdiDi>69458686HD-350MD</basicUdiDi>
    <tradeName>HD-350S</tradeName>
    <deviceName>Image Processor</deviceName>
    <manufacturerName>SONOSCAPE MEDICAL CORP.</manufacturerName>
    <manufacturerSrn>CN-MF-000009623</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020401</emdnCode>
    <emdnDescription>INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:00:35.192Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429028584</udiDi>
    <basicUdiDi>69454290ES001LT</basicUdiDi>
    <tradeName>4K endoscopic camera system</tradeName>
    <deviceName>4K endoscopic camera system</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020401</emdnCode>
    <emdnDescription>INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VIS-60B</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:24:26.732Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429028577</udiDi>
    <basicUdiDi>69454290ES001LT</basicUdiDi>
    <tradeName>4K endoscopic camera system</tradeName>
    <deviceName>4K endoscopic camera system</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020401</emdnCode>
    <emdnDescription>INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VIS-60A</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:24:25.530Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429028560</udiDi>
    <basicUdiDi>69454290ES001LT</basicUdiDi>
    <tradeName>4K endoscopic camera system</tradeName>
    <deviceName>4K endoscopic camera system</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020401</emdnCode>
    <emdnDescription>INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VIS-60</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:24:24.337Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429028553</udiDi>
    <basicUdiDi>69454290ES001LT</basicUdiDi>
    <tradeName>4K endoscopic camera system</tradeName>
    <deviceName>4K endoscopic camera system</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020401</emdnCode>
    <emdnDescription>INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VIS-50B</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:24:23.139Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429028546</udiDi>
    <basicUdiDi>69454290ES001LT</basicUdiDi>
    <tradeName>4K endoscopic camera system</tradeName>
    <deviceName>4K endoscopic camera system</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020401</emdnCode>
    <emdnDescription>INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VIS-50A</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:24:17.565Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429028539</udiDi>
    <basicUdiDi>69454290ES001LT</basicUdiDi>
    <tradeName>4K endoscopic camera system</tradeName>
    <deviceName>4K endoscopic camera system</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020401</emdnCode>
    <emdnDescription>INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VIS-50</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:24:16.032Z</lastUpdated>
  </row>
  <row>
    <udiDi>06932619742917</udiDi>
    <basicUdiDi>69326197DU56654HN</basicUdiDi>
    <tradeName>06932619742917</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Transmed (China) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000029614</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12020401</emdnCode>
    <emdnDescription>INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G09009</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:09:20.708Z</lastUpdated>
  </row>
  <row>
    <udiDi>06932619742900</udiDi>
    <basicUdiDi>69326197DU56654HN</basicUdiDi>
    <tradeName>06932619742900</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Transmed (China) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000029614</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12020401</emdnCode>
    <emdnDescription>INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G09008</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:09:19.511Z</lastUpdated>
  </row>
  <row>
    <udiDi>06932619742894</udiDi>
    <basicUdiDi>69326197DU56654HN</basicUdiDi>
    <tradeName>06932619742894</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Transmed (China) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000029614</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12020401</emdnCode>
    <emdnDescription>INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G09007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:09:18.303Z</lastUpdated>
  </row>
  <row>
    <udiDi>06932619742887</udiDi>
    <basicUdiDi>69326197DU56654HN</basicUdiDi>
    <tradeName>06932619742887</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Transmed (China) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000029614</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12020401</emdnCode>
    <emdnDescription>INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G09006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:09:17.113Z</lastUpdated>
  </row>
  <row>
    <udiDi>06932619742870</udiDi>
    <basicUdiDi>69326197DU56654HN</basicUdiDi>
    <tradeName>06932619742870</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Transmed (China) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000029614</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12020401</emdnCode>
    <emdnDescription>INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G09005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:09:15.922Z</lastUpdated>
  </row>
  <row>
    <udiDi>06932619742863</udiDi>
    <basicUdiDi>69326197DU56654HN</basicUdiDi>
    <tradeName>06932619742863</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Transmed (China) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000029614</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12020401</emdnCode>
    <emdnDescription>INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G09004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:09:14.703Z</lastUpdated>
  </row>
  <row>
    <udiDi>06932619742856</udiDi>
    <basicUdiDi>69326197DU56654HN</basicUdiDi>
    <tradeName>06932619742856</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Transmed (China) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000029614</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12020401</emdnCode>
    <emdnDescription>INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G09003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:09:13.502Z</lastUpdated>
  </row>
  <row>
    <udiDi>06932619742849</udiDi>
    <basicUdiDi>69326197DU56654HN</basicUdiDi>
    <tradeName>06932619742849</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Transmed (China) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000029614</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12020401</emdnCode>
    <emdnDescription>INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G09002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:09:12.326Z</lastUpdated>
  </row>
</eudamedExport>