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<eudamedExport entity="devices">
  <row>
    <udiDi>06944413801806</udiDi>
    <basicUdiDi>69444138SD3SU7</basicUdiDi>
    <tradeName>Ultrasonic Pocket Doppler</tradeName>
    <deviceName>Ultrasonic Pocket Doppler</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>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD3 PLUS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:46:39.639Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413801790</udiDi>
    <basicUdiDi>69444138SD3SU7</basicUdiDi>
    <tradeName>Ultrasonic Pocket Doppler</tradeName>
    <deviceName>Ultrasonic Pocket Doppler</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>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD3 LITE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:46:37.199Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413801783</udiDi>
    <basicUdiDi>69444138SD3SU7</basicUdiDi>
    <tradeName>Ultrasonic Pocket Doppler</tradeName>
    <deviceName>Ultrasonic Pocket Doppler</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>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:46:29.401Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413800809</udiDi>
    <basicUdiDi>69444138SD5SUD</basicUdiDi>
    <tradeName>Ultrasonic TableTop Doppler</tradeName>
    <deviceName>Ultrasonic TableTop Doppler</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>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD6</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:45:48.953Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413800793</udiDi>
    <basicUdiDi>69444138SD5SUD</basicUdiDi>
    <tradeName>Ultrasonic TableTop Doppler</tradeName>
    <deviceName>Ultrasonic TableTop Doppler</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>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:45:44.328Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413800175</udiDi>
    <basicUdiDi>69444138SonotraxSC8</basicUdiDi>
    <tradeName>Ultrasonic Pocket Doppler</tradeName>
    <deviceName>Ultrasonic Pocket Doppler</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>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SONOTRAX II Pro</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:43:46.955Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413800168</udiDi>
    <basicUdiDi>69444138SonotraxSC8</basicUdiDi>
    <tradeName>Ultrasonic Pocket Doppler</tradeName>
    <deviceName>Ultrasonic Pocket Doppler</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>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SONOTRAX II</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:43:39.477Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413800151</udiDi>
    <basicUdiDi>69444138SonotraxSC8</basicUdiDi>
    <tradeName>Ultrasonic Pocket Doppler</tradeName>
    <deviceName>Ultrasonic Pocket Doppler</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>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SONOTRAX Pro</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:43:38.404Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413800137</udiDi>
    <basicUdiDi>69444138SonotraxSC8</basicUdiDi>
    <tradeName>Ultrasonic Pocket Doppler</tradeName>
    <deviceName>Ultrasonic Pocket Doppler</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>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SONOTRAX Basic</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:43:37.616Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413800144</udiDi>
    <basicUdiDi>69444138SonotraxSC8</basicUdiDi>
    <tradeName>Ultrasonic Pocket Doppler</tradeName>
    <deviceName>Ultrasonic Pocket Doppler</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>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SONOTRAX Basic A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:43:35.907Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413800120</udiDi>
    <basicUdiDi>69444138SonotraxSC8</basicUdiDi>
    <tradeName>Ultrasonic Pocket Doppler</tradeName>
    <deviceName>Ultrasonic Pocket Doppler</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>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SONOTRAX Lite</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:43:32.221Z</lastUpdated>
  </row>
  <row>
    <udiDi>(01)06970442094575</udiDi>
    <basicUdiDi>697044209FDX8</basicUdiDi>
    <tradeName>Fetal Doppler</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vcomin Technology Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000039445</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FD-530B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T20:23:04.088Z</lastUpdated>
  </row>
  <row>
    <udiDi>(01)06970442094599</udiDi>
    <basicUdiDi>697044209FDX8</basicUdiDi>
    <tradeName>Fetal Doppler</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vcomin Technology Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000039445</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FD-530G</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T20:23:04.074Z</lastUpdated>
  </row>
  <row>
    <udiDi>(01)06970442094612</udiDi>
    <basicUdiDi>697044209FDX8</basicUdiDi>
    <tradeName>Fetal Doppler</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vcomin Technology Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000039445</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FD-540B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T20:23:04.054Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937683443128</udiDi>
    <basicUdiDi>B-06937683443128</basicUdiDi>
    <tradeName>Doppler Fetal Heart Rate Detector</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Biocare Bio-Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005653</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90210106</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T20:35:43.569Z</lastUpdated>
  </row>
  <row>
    <udiDi>06927394588881</udiDi>
    <basicUdiDi>69273945FD01SD</basicUdiDi>
    <tradeName>Fetal doppler</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hunan Accurate Bio-Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012835</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD51A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T02:45:28.107Z</lastUpdated>
  </row>
  <row>
    <udiDi>06927394578646</udiDi>
    <basicUdiDi>B-06927394578646</basicUdiDi>
    <tradeName>Fetal doppler</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hunan Accurate Bio-Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012835</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD50E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T02:45:26.911Z</lastUpdated>
  </row>
  <row>
    <udiDi>06927394575546</udiDi>
    <basicUdiDi>B-06927394575546</basicUdiDi>
    <tradeName>Fetal doppler</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hunan Accurate Bio-Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012835</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD51F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T02:45:24.508Z</lastUpdated>
  </row>
  <row>
    <udiDi>06927394568685</udiDi>
    <basicUdiDi>69273945FD01SD</basicUdiDi>
    <tradeName>Fetal doppler</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hunan Accurate Bio-Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012835</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD50B</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T02:45:22.098Z</lastUpdated>
  </row>
  <row>
    <udiDi>06927394568463</udiDi>
    <basicUdiDi>69273945FD01SD</basicUdiDi>
    <tradeName>Fetal doppler</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hunan Accurate Bio-Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012835</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD50D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T02:45:20.893Z</lastUpdated>
  </row>
</eudamedExport>