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<eudamedExport entity="devices">
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    <udiDi>03770033463000</udiDi>
    <basicUdiDi>3770033463FETOLY4K</basicUdiDi>
    <tradeName>03770033463000</tradeName>
    <deviceName>FETOLY-HEART</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-HEART</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:14:20.092Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770024341034</udiDi>
    <basicUdiDi>3770024341SuspectS6</basicUdiDi>
    <tradeName>Sonio Suspect</tradeName>
    <deviceName>Sonio Suspect</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>v1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:05:39.823Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770024341027</udiDi>
    <basicUdiDi>3770024341DetectMM</basicUdiDi>
    <tradeName>Sonio Detect</tradeName>
    <deviceName>Sonio Detect</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>v1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:05:39.030Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970706360637</udiDi>
    <basicUdiDi>B-06970706360637</basicUdiDi>
    <tradeName>TOCO Fetal transducer</tradeName>
    <deviceName>TOCO Fetal transducer</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>MDD</legislation>
    <emdnCode>Z12080101</emdnCode>
    <emdnDescription>FOETAL MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FTC-SL03</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-30T05:21:06.382Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970706360620</udiDi>
    <basicUdiDi>B-06970706360620</basicUdiDi>
    <tradeName>TOCO Fetal transducer</tradeName>
    <deviceName>TOCO Fetal transducer</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>MDD</legislation>
    <emdnCode>Z12080101</emdnCode>
    <emdnDescription>FOETAL MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FTC-SL02</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-30T05:21:05.184Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970706360613</udiDi>
    <basicUdiDi>B-06970706360613</basicUdiDi>
    <tradeName>TOCO Fetal transducer</tradeName>
    <deviceName>TOCO Fetal transducer</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>MDD</legislation>
    <emdnCode>Z12080101</emdnCode>
    <emdnDescription>FOETAL MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FTC-SL01</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-30T05:20:59.179Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970706360606</udiDi>
    <basicUdiDi>B-06970706360606</basicUdiDi>
    <tradeName>TOCO Fetal transducer</tradeName>
    <deviceName>TOCO Fetal transducer</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>MDD</legislation>
    <emdnCode>Z12080101</emdnCode>
    <emdnDescription>FOETAL MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FTC-SC02</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-30T05:20:57.976Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970706360583</udiDi>
    <basicUdiDi>B-06970706360583</basicUdiDi>
    <tradeName>TOCO Fetal transducer</tradeName>
    <deviceName>TOCO Fetal transducer</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>MDD</legislation>
    <emdnCode>Z12080101</emdnCode>
    <emdnDescription>FOETAL MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FTC-SC01</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-30T05:20:56.773Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970706360576</udiDi>
    <basicUdiDi>B-06970706360576</basicUdiDi>
    <tradeName>TOCO Fetal transducer</tradeName>
    <deviceName>TOCO Fetal transducer</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>MDD</legislation>
    <emdnCode>Z12080101</emdnCode>
    <emdnDescription>FOETAL MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FTC-AL01</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-30T05:20:55.578Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970706360569</udiDi>
    <basicUdiDi>B-06970706360569</basicUdiDi>
    <tradeName>TOCO Fetal transducer</tradeName>
    <deviceName>TOCO Fetal transducer</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>MDD</legislation>
    <emdnCode>Z12080101</emdnCode>
    <emdnDescription>FOETAL MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FTC-GE02</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-30T05:20:49.573Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970706360552</udiDi>
    <basicUdiDi>B-06970706360552</basicUdiDi>
    <tradeName>TOCO Fetal transducer</tradeName>
    <deviceName>TOCO Fetal transducer</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>MDD</legislation>
    <emdnCode>Z12080101</emdnCode>
    <emdnDescription>FOETAL MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FTC-GE01</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-30T05:20:48.367Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970706360545</udiDi>
    <basicUdiDi>B-06970706360545</basicUdiDi>
    <tradeName>TOCO Fetal transducer</tradeName>
    <deviceName>TOCO Fetal transducer</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>MDD</legislation>
    <emdnCode>Z12080101</emdnCode>
    <emdnDescription>FOETAL MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FTC-PH01</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-30T05:20:47.165Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970706360538</udiDi>
    <basicUdiDi>B-06970706360538</basicUdiDi>
    <tradeName>Ultrasound Fetal transducer</tradeName>
    <deviceName>Ultrasound Fetal transducer</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>MDD</legislation>
    <emdnCode>Z12080101</emdnCode>
    <emdnDescription>FOETAL MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FUS-ED02</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-30T05:20:45.963Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970706360521</udiDi>
    <basicUdiDi>B-06970706360521</basicUdiDi>
    <tradeName>Ultrasound Fetal transducer</tradeName>
    <deviceName>Ultrasound Fetal transducer</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>MDD</legislation>
    <emdnCode>Z12080101</emdnCode>
    <emdnDescription>FOETAL MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FUS-SC04</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-30T05:20:39.964Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970706360514</udiDi>
    <basicUdiDi>B-06970706360514</basicUdiDi>
    <tradeName>Ultrasound Fetal transducer</tradeName>
    <deviceName>Ultrasound Fetal transducer</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>MDD</legislation>
    <emdnCode>Z12080101</emdnCode>
    <emdnDescription>FOETAL MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FUS-AL03</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-30T05:20:38.768Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970706360507</udiDi>
    <basicUdiDi>B-06970706360507</basicUdiDi>
    <tradeName>Ultrasound Fetal transducer</tradeName>
    <deviceName>Ultrasound Fetal transducer</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>MDD</legislation>
    <emdnCode>Z12080101</emdnCode>
    <emdnDescription>FOETAL MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FUS-AL02</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-30T05:20:37.560Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970706360491</udiDi>
    <basicUdiDi>B-06970706360491</basicUdiDi>
    <tradeName>Ultrasound Fetal transducer</tradeName>
    <deviceName>Ultrasound Fetal transducer</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>MDD</legislation>
    <emdnCode>Z12080101</emdnCode>
    <emdnDescription>FOETAL MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FUS-SL03</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-30T05:20:36.359Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970706360484</udiDi>
    <basicUdiDi>B-06970706360484</basicUdiDi>
    <tradeName>Ultrasound Fetal transducer</tradeName>
    <deviceName>Ultrasound Fetal transducer</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>MDD</legislation>
    <emdnCode>Z12080101</emdnCode>
    <emdnDescription>FOETAL MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FUS-SC03</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-30T05:20:30.354Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970706360477</udiDi>
    <basicUdiDi>B-06970706360477</basicUdiDi>
    <tradeName>Ultrasound Fetal transducer</tradeName>
    <deviceName>Ultrasound Fetal transducer</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>MDD</legislation>
    <emdnCode>Z12080101</emdnCode>
    <emdnDescription>FOETAL MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FUS-ED01</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-30T05:20:29.157Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970706360460</udiDi>
    <basicUdiDi>B-06970706360460</basicUdiDi>
    <tradeName>Ultrasound Fetal transducer</tradeName>
    <deviceName>Ultrasound Fetal transducer</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>MDD</legislation>
    <emdnCode>Z12080101</emdnCode>
    <emdnDescription>FOETAL MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FUS-SC02</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-30T05:20:27.950Z</lastUpdated>
  </row>
</eudamedExport>