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<eudamedExport entity="devices">
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    <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>08594201470103</udiDi>
    <basicUdiDi>859420147VL22F001MT</basicUdiDi>
    <tradeName>Heated bed for newborns and infants VL-22</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ALFAMEDIC s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000037764</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080407</emdnCode>
    <emdnDescription>NEONATAL RADIANT WARMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VL-22-S-M</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T06:52:44.857Z</lastUpdated>
  </row>
  <row>
    <udiDi>08594201470110</udiDi>
    <basicUdiDi>859420147VL22F001MT</basicUdiDi>
    <tradeName>Heated bed for newborns and infants VL-22</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ALFAMEDIC s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000037764</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080407</emdnCode>
    <emdnDescription>NEONATAL RADIANT WARMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VL-22-S-Z</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T06:52:44.843Z</lastUpdated>
  </row>
  <row>
    <udiDi>08594201470127</udiDi>
    <basicUdiDi>859420147VL22F001MT</basicUdiDi>
    <tradeName>Heated bed for newborns and infants VL-22</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ALFAMEDIC s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000037764</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080407</emdnCode>
    <emdnDescription>NEONATAL RADIANT WARMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VL-22-S-O</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T06:52:44.820Z</lastUpdated>
  </row>
  <row>
    <udiDi>08594201470134</udiDi>
    <basicUdiDi>859420147VL22F001MT</basicUdiDi>
    <tradeName>Heated bed for newborns and infants VL-22</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ALFAMEDIC s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000037764</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080407</emdnCode>
    <emdnDescription>NEONATAL RADIANT WARMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VL-22-G-B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T06:52:44.801Z</lastUpdated>
  </row>
  <row>
    <udiDi>08594201470141</udiDi>
    <basicUdiDi>859420147VL22F001MT</basicUdiDi>
    <tradeName>Heated bed for newborns and infants VL-22</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ALFAMEDIC s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000037764</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080407</emdnCode>
    <emdnDescription>NEONATAL RADIANT WARMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VL-22-G-M</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T06:52:44.780Z</lastUpdated>
  </row>
  <row>
    <udiDi>08594201470158</udiDi>
    <basicUdiDi>859420147VL22F001MT</basicUdiDi>
    <tradeName>Heated bed for newborns and infants VL-22</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ALFAMEDIC s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000037764</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080407</emdnCode>
    <emdnDescription>NEONATAL RADIANT WARMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VL-22-G-Z</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T06:52:44.764Z</lastUpdated>
  </row>
  <row>
    <udiDi>08594201470165</udiDi>
    <basicUdiDi>859420147VL22F001MT</basicUdiDi>
    <tradeName>Heated bed for newborns and infants VL-22</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ALFAMEDIC s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000037764</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080407</emdnCode>
    <emdnDescription>NEONATAL RADIANT WARMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VL-22-G-O</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T06:52:44.744Z</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>04270002246713</udiDi>
    <basicUdiDi>42700022467BettenEM</basicUdiDi>
    <tradeName>Classic 1.2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>vivipar GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008098</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080399</emdnCode>
    <emdnDescription>VARIOUS CHILDBIRTH SUPPORT AND MATERNAL ASSISTANCE INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21.20.000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:26:14.628Z</lastUpdated>
  </row>
  <row>
    <udiDi>04270002246720</udiDi>
    <basicUdiDi>42700022467BettenEM</basicUdiDi>
    <tradeName>Classic 1.4</tradeName>
    <deviceName></deviceName>
    <manufacturerName>vivipar GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008098</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080399</emdnCode>
    <emdnDescription>VARIOUS CHILDBIRTH SUPPORT AND MATERNAL ASSISTANCE INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21.00.000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:26:14.607Z</lastUpdated>
  </row>
</eudamedExport>