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<eudamedExport entity="devices">
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    <basicUdiDi>69454290BL002JB</basicUdiDi>
    <tradeName>Neonatal Phototherapy Bed</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BL20B</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:30:38.046Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429024630</udiDi>
    <basicUdiDi>69454290BL002JB</basicUdiDi>
    <tradeName>Neonatal Phototherapy Bed</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BL20A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:17:01.258Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429024623</udiDi>
    <basicUdiDi>69454290BL002JB</basicUdiDi>
    <tradeName>Neonatal Phototherapy Bed</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BL20</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:16:55.263Z</lastUpdated>
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    <udiDi>06945429024067</udiDi>
    <basicUdiDi>69454290BL003JD</basicUdiDi>
    <tradeName>Infant Phototherapy Equipment</tradeName>
    <deviceName>Infant Phototherapy Equipment</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BL60A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:16:51.650Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429024050</udiDi>
    <basicUdiDi>69454290BL003JD</basicUdiDi>
    <tradeName>Infant Phototherapy Equipment</tradeName>
    <deviceName>Infant Phototherapy Equipment</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BL60</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:16:46.143Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429021189</udiDi>
    <basicUdiDi>69454290BL001J9</basicUdiDi>
    <tradeName>Infant Phototherapy Equipment</tradeName>
    <deviceName>Infant Phototherapy Equipment</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BL70A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:12:32.280Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429021172</udiDi>
    <basicUdiDi>69454290BL001J9</basicUdiDi>
    <tradeName>Infant Phototherapy Equipment</tradeName>
    <deviceName>Infant Phototherapy Equipment</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BL70</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:12:30.360Z</lastUpdated>
  </row>
  <row>
    <udiDi>06920716304695</udiDi>
    <basicUdiDi>69207163XHZ-002QQ</basicUdiDi>
    <tradeName>Neonate Bilirubin Phototherapy Equipment</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo David Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009962</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XHZ-200A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T14:43:52.883Z</lastUpdated>
  </row>
  <row>
    <udiDi>06920716304718</udiDi>
    <basicUdiDi>69207163XHZ-001QN</basicUdiDi>
    <tradeName>Neonate Bilirubin Phototherapy Equipment</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo David Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009962</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XHZ-90S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T14:43:52.854Z</lastUpdated>
  </row>
  <row>
    <udiDi>06920716305104</udiDi>
    <basicUdiDi>69207163NBB-0018N</basicUdiDi>
    <tradeName>Neonate Bilirubin Phototherapy Equipment</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo David Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009962</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NBB-II</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T14:43:52.530Z</lastUpdated>
  </row>
  <row>
    <udiDi>06920716305111</udiDi>
    <basicUdiDi>69207163XHZ-001QN</basicUdiDi>
    <tradeName>Neonate Bilirubin Phototherapy Equipment</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo David Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009962</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XHZ-90</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T14:43:52.510Z</lastUpdated>
  </row>
  <row>
    <udiDi>06920716305128</udiDi>
    <basicUdiDi>69207163XHZ-001QN</basicUdiDi>
    <tradeName>Neonate Bilirubin Phototherapy Equipment</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo David Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009962</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XHZ-90L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T14:43:52.490Z</lastUpdated>
  </row>
  <row>
    <udiDi>06920716305197</udiDi>
    <basicUdiDi>69207163XHZ-001QN</basicUdiDi>
    <tradeName>Neonate Bilirubin Phototherapy Equipment</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo David Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009962</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XHZ-90P</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T14:43:52.335Z</lastUpdated>
  </row>
  <row>
    <udiDi>06920716305203</udiDi>
    <basicUdiDi>69207163NBB-0018N</basicUdiDi>
    <tradeName>Neonate Bilirubin Phototherapy Equipment</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo David Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009962</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NBB-III</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T14:43:52.308Z</lastUpdated>
  </row>
  <row>
    <udiDi>06920716305210</udiDi>
    <basicUdiDi>69207163NBB-0018N</basicUdiDi>
    <tradeName>Neonate Bilirubin Phototherapy Equipment</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo David Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009962</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NBB-IV</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T14:43:52.294Z</lastUpdated>
  </row>
  <row>
    <udiDi>06920716305456</udiDi>
    <basicUdiDi>69207163YG-001DZ</basicUdiDi>
    <tradeName>Neonate Bilirubin Phototherapy Equipment</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo David Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009962</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YG-III</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T14:43:51.857Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840682116541</udiDi>
    <basicUdiDi>8406821BUG00394HW</basicUdiDi>
    <tradeName>Giraffe Blue Spot PT Lite</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Datex-Ohmeda Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002206</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>M1231533</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:04:35.474Z</lastUpdated>
  </row>
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    <udiDi>00840682116572</udiDi>
    <basicUdiDi>8406821BUG00394HW</basicUdiDi>
    <tradeName>Giraffe Blue Spot PT Lite</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Datex-Ohmeda Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002206</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>M1224917</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:04:35.456Z</lastUpdated>
  </row>
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    <udiDi>00840682143493</udiDi>
    <basicUdiDi>8406821BUG00394HW</basicUdiDi>
    <tradeName>Giraffe Blue Spot PT Lite</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Datex-Ohmeda Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002206</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M1225067</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:04:09.015Z</lastUpdated>
  </row>
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    <udiDi>08695406312202</udiDi>
    <basicUdiDi>8695406000PTP3</basicUdiDi>
    <tradeName>maviLed Phototherapy Device Overhead Only</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ASTEKMED MEDIKAL IC VE DIS TIC AS</manufacturerName>
    <manufacturerSrn>TR-MF-000018605</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>31220</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T19:44:44.351Z</lastUpdated>
  </row>
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