<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00812432020996</udiDi>
    <basicUdiDi>B-00812432020996</basicUdiDi>
    <tradeName>00812432020996</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lumitex Medical Devices, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000030520</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5813128</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:23:11.190Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812432020989</udiDi>
    <basicUdiDi>B-00812432020989</basicUdiDi>
    <tradeName>00812432020989</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lumitex Medical Devices, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000030520</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5813127</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:23:10.382Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812432020958</udiDi>
    <basicUdiDi>B-00812432020958</basicUdiDi>
    <tradeName>00812432020958</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lumitex Medical Devices, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000030520</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2108683-001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:23:06.378Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812432020804</udiDi>
    <basicUdiDi>B-00812432020804</basicUdiDi>
    <tradeName>00812432020804</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lumitex Medical Devices, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000030520</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2108736-001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:23:05.598Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812432020729</udiDi>
    <basicUdiDi>B-00812432020729</basicUdiDi>
    <tradeName>00812432020729</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lumitex Medical Devices, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000030520</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2108666-001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:23:04.774Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812432020484</udiDi>
    <basicUdiDi>B-00812432020484</basicUdiDi>
    <tradeName>00812432020484</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lumitex Medical Devices, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000030520</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2106573-001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:22:59.978Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908025930017</udiDi>
    <basicUdiDi>8908025930B7006UX</basicUdiDi>
    <tradeName>Bilitron 7006</tradeName>
    <deviceName>Double Surface Phototherapy Unit</deviceName>
    <manufacturerName>Fanem Medical Devices India Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000039532</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>FANEM-CTL-7006</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:09:08.012Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908025930000</udiDi>
    <basicUdiDi>8908025930BS20064B</basicUdiDi>
    <tradeName>Bilitron Sky 2006</tradeName>
    <deviceName>Single Surface Phototherapy Unit</deviceName>
    <manufacturerName>Fanem Medical Devices India Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000039532</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>FANEM-CTL-2006</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:09:07.233Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908022817038</udiDi>
    <basicUdiDi>8908022817AVIBPLLPHV2</basicUdiDi>
    <tradeName>AVI/AVI Healthcare</tradeName>
    <deviceName>Phototherapy Units</deviceName>
    <manufacturerName>AVI Healthcare Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000014676</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>--</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:08:28.751Z</lastUpdated>
  </row>
  <row>
    <udiDi>87208653770014</udiDi>
    <basicUdiDi>8720865377PhototherapyY7</basicUdiDi>
    <tradeName>Jauni</tradeName>
    <deviceName>Jauni System Kit</deviceName>
    <manufacturerName>Bilihome B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000025535</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>230115.JSK</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:10:38.390Z</lastUpdated>
  </row>
  <row>
    <udiDi>08695406000055</udiDi>
    <basicUdiDi>8695406000PTP3</basicUdiDi>
    <tradeName>maviLed Phototherapy Device</tradeName>
    <deviceName>maviLED Phototherapy Device</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>30220</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:43:39.964Z</lastUpdated>
  </row>
  <row>
    <udiDi>08594216240432</udiDi>
    <basicUdiDi>859421624FTL-620JX</basicUdiDi>
    <tradeName>INFANT PHOTOTHERAPEUTIC DEVICE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TSE spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000026442</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FTL-620</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:51:51.506Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840682117401</udiDi>
    <basicUdiDi>8406821BUG00395HY</basicUdiDi>
    <tradeName>Lullaby LED Phototherapy System</tradeName>
    <deviceName>Lullaby LED Phototherapy System</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>2052663-001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:55:46.677Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278022233</udiDi>
    <basicUdiDi>8406821BUG00394HW</basicUdiDi>
    <tradeName>Giraffe Blue Spot PT Lite</tradeName>
    <deviceName>Giraffe Blue Spot PT Lite</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>M1238506</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:50:38.224Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290015630054</udiDi>
    <basicUdiDi>729001563082000000058</basicUdiDi>
    <tradeName>BiliWrap</tradeName>
    <deviceName>BiliWrap , Phototherapy system</deviceName>
    <manufacturerName>Gerium Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000016697</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>820000000</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T22:18:30.989Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974805202065</udiDi>
    <basicUdiDi>697480520BL50DD8</basicUdiDi>
    <tradeName>06974805202065</tradeName>
    <deviceName>Infant Phototherapy Units</deviceName>
    <manufacturerName>Zhengzhou Dison Instrument and Meter Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021558</manufacturerSrn>
    <authorisedRepresentativeName>Share info GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005132</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BL-50D</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:32:34.132Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974805202072</udiDi>
    <basicUdiDi>697480520BL200D8P</basicUdiDi>
    <tradeName>06974805202072</tradeName>
    <deviceName>Infant Phototherapy Units</deviceName>
    <manufacturerName>Zhengzhou Dison Instrument and Meter Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021558</manufacturerSrn>
    <authorisedRepresentativeName>Share info GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005132</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BL-200D</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:30:14.017Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260598172008</udiDi>
    <basicUdiDi>42605981720BILISWADDLERK5</basicUdiDi>
    <tradeName>BiliSwaddler</tradeName>
    <deviceName>BiliSwadddler</deviceName>
    <manufacturerName>conceptnatal</manufacturerName>
    <manufacturerSrn>DE-MF-000010321</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20-00-100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:49:33.640Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278265074</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>M1236303</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T14:39:49.693Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429062045</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>BL20C</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:30:40.052Z</lastUpdated>
  </row>
</eudamedExport>