<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06944413807204</udiDi>
    <basicUdiDi>69444138FTS6Mobile58</basicUdiDi>
    <tradeName>Fetal Monitor</tradeName>
    <deviceName>Fetal 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 IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080101</emdnCode>
    <emdnDescription>FOETAL MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FTS-6 Mobile</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:05:09.927Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413801813</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 PRO</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:46:42.245Z</lastUpdated>
  </row>
  <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>03770024341041</udiDi>
    <basicUdiDi>3770024341DetectMM</basicUdiDi>
    <tradeName>Sonio Detect</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sonio</manufacturerName>
    <manufacturerSrn>FR-MF-000018467</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080192</emdnCode>
    <emdnDescription>PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>v2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T02:21:43.731Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770033463031</udiDi>
    <basicUdiDi>3770033463FETOLYv2ZB</basicUdiDi>
    <tradeName>03770033463031</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DIAGNOLY</manufacturerName>
    <manufacturerSrn>FR-MF-000037822</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080192</emdnCode>
    <emdnDescription>PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>FETOLY</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T02:20:54.156Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770033463048</udiDi>
    <basicUdiDi>3770033463FETOLYv2ZB</basicUdiDi>
    <tradeName>FETOLY</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DIAGNOLY</manufacturerName>
    <manufacturerSrn>FR-MF-000037822</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080192</emdnCode>
    <emdnDescription>PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FETOLY</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T02:20:54.147Z</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>06941691986812</udiDi>
    <basicUdiDi>B-06941691986812</basicUdiDi>
    <tradeName>Ultrasound Fetal transducer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orantech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000013859</manufacturerSrn>
    <authorisedRepresentativeName>Medten EU ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000034434</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080101</emdnCode>
    <emdnDescription>FOETAL MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FUS-PA01</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-25T13:25:56.684Z</lastUpdated>
  </row>
</eudamedExport>