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<eudamedExport entity="devices">
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    <udiDi>05904815542302</udiDi>
    <basicUdiDi>59048155423_MONAKO56</basicUdiDi>
    <tradeName>System MONAKO</tradeName>
    <deviceName>System MONAKO</deviceName>
    <manufacturerName>Sieć Badawcza Łukasiewicz - Krakowski Instytut Technologiczny</manufacturerName>
    <manufacturerSrn>PL-MF-000001669</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080101</emdnCode>
    <emdnDescription>FOETAL MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05904815542302</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:53:45.873Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904292005031</udiDi>
    <basicUdiDi>5904292005031YQ</basicUdiDi>
    <tradeName>PINIT</tradeName>
    <deviceName>Bladder scanner</deviceName>
    <manufacturerName>Echo-Son SA</manufacturerName>
    <manufacturerSrn>PL-MF-000004830</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080304</emdnCode>
    <emdnDescription>ULTRASONIC BLADDER VOLUME SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5904292005031</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:30:50.861Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903641127943</udiDi>
    <basicUdiDi>59036411279PREGNABITCLR9</basicUdiDi>
    <tradeName>Pregnabit Cloud</tradeName>
    <deviceName>Pregnabit Cloud</deviceName>
    <manufacturerName>Nestmedic S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002204</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1208010401</emdnCode>
    <emdnDescription>COMPLETE CARDIOTOCOGRAPHIC TELEMETRY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00002</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:06:19.117Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903641127929</udiDi>
    <basicUdiDi>59036411279PREGNABITPROYA</basicUdiDi>
    <tradeName>Pregnabit Pro</tradeName>
    <deviceName>Pregnabit Pro</deviceName>
    <manufacturerName>Nestmedic S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002204</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1208010401</emdnCode>
    <emdnDescription>COMPLETE CARDIOTOCOGRAPHIC TELEMETRY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00001</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:06:18.325Z</lastUpdated>
  </row>
  <row>
    <udiDi>05713315011252</udiDi>
    <basicUdiDi>5713315NA000204W</basicUdiDi>
    <tradeName>neoBLUE blanket Small pad</tradeName>
    <deviceName>neoBLUE blanket LED Phototherapy System</deviceName>
    <manufacturerName>Natus Medical Denmark ApS</manufacturerName>
    <manufacturerSrn>DK-MF-000001617</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>006898</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:13:16.998Z</lastUpdated>
  </row>
  <row>
    <udiDi>05713315011214</udiDi>
    <basicUdiDi>5713315TA000017Y</basicUdiDi>
    <tradeName>05713315011214</tradeName>
    <deviceName>neoBLUE nova</deviceName>
    <manufacturerName>Natus Medical Denmark ApS</manufacturerName>
    <manufacturerSrn>DK-MF-000001617</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>018213</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:13:14.589Z</lastUpdated>
  </row>
  <row>
    <udiDi>05708265015030</udiDi>
    <basicUdiDi>57082651017-1ZW</basicUdiDi>
    <tradeName>LiNA Xcise</tradeName>
    <deviceName>LiNA Xcise</deviceName>
    <manufacturerName>LiNA Medical AG</manufacturerName>
    <manufacturerSrn>CH-MF-000046832</manufacturerSrn>
    <authorisedRepresentativeName>LiNA Medical Polska Sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000039364</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080204</emdnCode>
    <emdnDescription>MORCELLATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MOR-1515-1-I</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:09:47.757Z</lastUpdated>
  </row>
  <row>
    <udiDi>05600802300138</udiDi>
    <basicUdiDi>560080230P-001P3</basicUdiDi>
    <tradeName>Neonate Bilirubin Phototherapy Equipment</tradeName>
    <deviceName>Neonate Bilirubin Phototherapy Equipment</deviceName>
    <manufacturerName>DAVID MEDICAL EUROPE, UNIPESSOAL LDA</manufacturerName>
    <manufacturerSrn>PT-MF-000042894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P-500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:41:29.323Z</lastUpdated>
  </row>
  <row>
    <udiDi>05600802300107</udiDi>
    <basicUdiDi>560080230W-001RG</basicUdiDi>
    <tradeName>. Infant Radiant Warmer</tradeName>
    <deviceName>Infant Radiant Warmer</deviceName>
    <manufacturerName>DAVID MEDICAL EUROPE, UNIPESSOAL LDA</manufacturerName>
    <manufacturerSrn>PT-MF-000042894</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>W-600</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:41:28.531Z</lastUpdated>
  </row>
  <row>
    <udiDi>05600802300022</udiDi>
    <basicUdiDi>560080230N-001ND</basicUdiDi>
    <tradeName>Infant Incubator</tradeName>
    <deviceName>Infant Incubator</deviceName>
    <manufacturerName>DAVID MEDICAL EUROPE, UNIPESSOAL LDA</manufacturerName>
    <manufacturerSrn>PT-MF-000042894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1208040301</emdnCode>
    <emdnDescription>FIXED NEONATAL INCUBATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N-520</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:41:27.714Z</lastUpdated>
  </row>
  <row>
    <udiDi>05600802300121</udiDi>
    <basicUdiDi>560080230P-001P3</basicUdiDi>
    <tradeName>Neonate Bilirubin Phototherapy Equipment</tradeName>
    <deviceName>Neonate Bilirubin Phototherapy Equipment</deviceName>
    <manufacturerName>DAVID MEDICAL EUROPE, UNIPESSOAL LDA</manufacturerName>
    <manufacturerSrn>PT-MF-000042894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P-300</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:30:23.754Z</lastUpdated>
  </row>
  <row>
    <udiDi>05600802300091</udiDi>
    <basicUdiDi>560080230W-001RG</basicUdiDi>
    <tradeName>Infant Radiant Warmer</tradeName>
    <deviceName>Infant Radiant Warmer</deviceName>
    <manufacturerName>DAVID MEDICAL EUROPE, UNIPESSOAL LDA</manufacturerName>
    <manufacturerSrn>PT-MF-000042894</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>W-500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:30:22.964Z</lastUpdated>
  </row>
  <row>
    <udiDi>05600802300077</udiDi>
    <basicUdiDi>560080230T-001QF</basicUdiDi>
    <tradeName>Transport Incubator</tradeName>
    <deviceName>Transport Incubator</deviceName>
    <manufacturerName>DAVID MEDICAL EUROPE, UNIPESSOAL LDA</manufacturerName>
    <manufacturerSrn>PT-MF-000042894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1208040302</emdnCode>
    <emdnDescription>MOBILE NEONATAL INCUBATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T-800</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:30:22.153Z</lastUpdated>
  </row>
  <row>
    <udiDi>05600802300015</udiDi>
    <basicUdiDi>560080230N-001ND</basicUdiDi>
    <tradeName>Infant Incubator</tradeName>
    <deviceName>Infant Incubator</deviceName>
    <manufacturerName>DAVID MEDICAL EUROPE, UNIPESSOAL LDA</manufacturerName>
    <manufacturerSrn>PT-MF-000042894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1208040301</emdnCode>
    <emdnDescription>FIXED NEONATAL INCUBATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N-500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:30:21.362Z</lastUpdated>
  </row>
  <row>
    <udiDi>05600802300169</udiDi>
    <basicUdiDi>560080230D-001JX</basicUdiDi>
    <tradeName>Transcutaneous Jaundice Detector</tradeName>
    <deviceName>Transcutaneous Jaundice Detector</deviceName>
    <manufacturerName>DAVID MEDICAL EUROPE, UNIPESSOAL LDA</manufacturerName>
    <manufacturerSrn>PT-MF-000042894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080410</emdnCode>
    <emdnDescription>TRANSCUTANEOUS BILIRUBINOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:25:57.723Z</lastUpdated>
  </row>
  <row>
    <udiDi>05600802300114</udiDi>
    <basicUdiDi>560080230P-001P3</basicUdiDi>
    <tradeName>Neonate Bilirubin Phototherapy Equipment</tradeName>
    <deviceName>Neonate Bilirubin Phototherapy Equipment</deviceName>
    <manufacturerName>DAVID MEDICAL EUROPE, UNIPESSOAL LDA</manufacturerName>
    <manufacturerSrn>PT-MF-000042894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P-200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:25:41.667Z</lastUpdated>
  </row>
  <row>
    <udiDi>05600802300084</udiDi>
    <basicUdiDi>560080230W-001RG</basicUdiDi>
    <tradeName>Infant Radiant Warmer</tradeName>
    <deviceName>Infant Radiant Warmer</deviceName>
    <manufacturerName>DAVID MEDICAL EUROPE, UNIPESSOAL LDA</manufacturerName>
    <manufacturerSrn>PT-MF-000042894</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>W-300</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:25:40.882Z</lastUpdated>
  </row>
  <row>
    <udiDi>05600802300060</udiDi>
    <basicUdiDi>560080230T-001QF</basicUdiDi>
    <tradeName>Transport Incubator</tradeName>
    <deviceName>Transport Incubator</deviceName>
    <manufacturerName>DAVID MEDICAL EUROPE, UNIPESSOAL LDA</manufacturerName>
    <manufacturerSrn>PT-MF-000042894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1208040302</emdnCode>
    <emdnDescription>MOBILE NEONATAL INCUBATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T-500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:25:39.259Z</lastUpdated>
  </row>
  <row>
    <udiDi>05600802300053</udiDi>
    <basicUdiDi>560080230N-002NF</basicUdiDi>
    <tradeName>Infant Incubator</tradeName>
    <deviceName>Infant Incubator</deviceName>
    <manufacturerName>DAVID MEDICAL EUROPE, UNIPESSOAL LDA</manufacturerName>
    <manufacturerSrn>PT-MF-000042894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1208040301</emdnCode>
    <emdnDescription>FIXED NEONATAL INCUBATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N-800</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:25:36.869Z</lastUpdated>
  </row>
  <row>
    <udiDi>05600802300008</udiDi>
    <basicUdiDi>560080230N-001ND</basicUdiDi>
    <tradeName>Infant Incubator</tradeName>
    <deviceName>Infant Incubator</deviceName>
    <manufacturerName>DAVID MEDICAL EUROPE, UNIPESSOAL LDA</manufacturerName>
    <manufacturerSrn>PT-MF-000042894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1208040301</emdnCode>
    <emdnDescription>FIXED NEONATAL INCUBATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N-200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:25:35.258Z</lastUpdated>
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</eudamedExport>