<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06920716303421</udiDi>
    <basicUdiDi>69207163NE-0018U</basicUdiDi>
    <tradeName>Neonate eyeshade</tradeName>
    <deviceName>Neonate eyeshade</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0201</emdnCode>
    <emdnDescription>PHOTOTHERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NE-B(L)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:06:16.822Z</lastUpdated>
  </row>
  <row>
    <udiDi>05713315011764</udiDi>
    <basicUdiDi>5713315NA0002354</basicUdiDi>
    <tradeName>05713315011764</tradeName>
    <deviceName>Biliband Eye Protector</deviceName>
    <manufacturerName>Natus Medical Denmark ApS</manufacturerName>
    <manufacturerSrn>DK-MF-000001617</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0201</emdnCode>
    <emdnDescription>PHOTOTHERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>900644</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:13:23.403Z</lastUpdated>
  </row>
  <row>
    <udiDi>06920716303445</udiDi>
    <basicUdiDi>69207163NE-0018U</basicUdiDi>
    <tradeName>Neonate eyeshade</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0201</emdnCode>
    <emdnDescription>PHOTOTHERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NE-B(M)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:56:57.799Z</lastUpdated>
  </row>
  <row>
    <udiDi>06920716303469</udiDi>
    <basicUdiDi>69207163NE-0018U</basicUdiDi>
    <tradeName>Neonate eyeshade</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0201</emdnCode>
    <emdnDescription>PHOTOTHERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NE-B(S)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:56:57.609Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817770021834</udiDi>
    <basicUdiDi>081777002EyeMax2CU</basicUdiDi>
    <tradeName>EyeMax 2 Preemie</tradeName>
    <deviceName>EyeMax 2</deviceName>
    <manufacturerName>Maxtec, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003961</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0201</emdnCode>
    <emdnDescription>PHOTOTHERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R300P02</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:00:18.316Z</lastUpdated>
  </row>
  <row>
    <udiDi>06920716303360</udiDi>
    <basicUdiDi>69207163NE-0018U</basicUdiDi>
    <tradeName>Neonate eyeshade</tradeName>
    <deviceName>Neonate eyeshade</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0201</emdnCode>
    <emdnDescription>PHOTOTHERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NE-A(L)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:52:37.948Z</lastUpdated>
  </row>
  <row>
    <udiDi>06920716303407</udiDi>
    <basicUdiDi>69207163NE-0018U</basicUdiDi>
    <tradeName>Neonate eyeshade</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0201</emdnCode>
    <emdnDescription>PHOTOTHERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NE-A(S)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:46:19.380Z</lastUpdated>
  </row>
  <row>
    <udiDi>06920716303384</udiDi>
    <basicUdiDi>69207163NE-0018U</basicUdiDi>
    <tradeName>Neonate eyeshade</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0201</emdnCode>
    <emdnDescription>PHOTOTHERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NE-A(M)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:46:17.417Z</lastUpdated>
  </row>
  <row>
    <udiDi>69570594001286</udiDi>
    <basicUdiDi>69570594YZ001YJ</basicUdiDi>
    <tradeName>69570594001286</tradeName>
    <deviceName>Infant Phototherapy Eye Mask</deviceName>
    <manufacturerName>Shandong Huasai Benquan Biotechnology Company Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000057549</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0201</emdnCode>
    <emdnDescription>PHOTOTHERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-29T20:10:50.073Z</lastUpdated>
  </row>
  <row>
    <udiDi>05713315011771</udiDi>
    <basicUdiDi>5713315NA0002354</basicUdiDi>
    <tradeName>05713315011771</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Natus Medical Denmark ApS</manufacturerName>
    <manufacturerSrn>DK-MF-000001617</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>V0201</emdnCode>
    <emdnDescription>PHOTOTHERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>900643</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-27T13:28:47.929Z</lastUpdated>
  </row>
  <row>
    <udiDi>05713315011788</udiDi>
    <basicUdiDi>5713315NA0002354</basicUdiDi>
    <tradeName>05713315011788</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Natus Medical Denmark ApS</manufacturerName>
    <manufacturerSrn>DK-MF-000001617</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>V0201</emdnCode>
    <emdnDescription>PHOTOTHERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>900642</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-27T13:28:47.906Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817770021841</udiDi>
    <basicUdiDi>081777002EyeMax2CU</basicUdiDi>
    <tradeName>EyeMax 2 Micro 20 pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Maxtec, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003961</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>V0201</emdnCode>
    <emdnDescription>PHOTOTHERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R300P03</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T14:41:38.418Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817770022022</udiDi>
    <basicUdiDi>081777002EyeMax2CU</basicUdiDi>
    <tradeName>EyeMax 2, F&amp;P Regular 20/pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Maxtec, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003961</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>V0201</emdnCode>
    <emdnDescription>PHOTOTHERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R300P01-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T14:41:38.386Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817770022039</udiDi>
    <basicUdiDi>081777002EyeMax2CU</basicUdiDi>
    <tradeName>EyeMax 2, Mediprema Regular 20/pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Maxtec, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003961</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>V0201</emdnCode>
    <emdnDescription>PHOTOTHERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R300P01-002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T14:41:38.355Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817770022046</udiDi>
    <basicUdiDi>081777002EyeMax2CU</basicUdiDi>
    <tradeName>EyeMax 2, Bioptron Regular</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Maxtec, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003961</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>V0201</emdnCode>
    <emdnDescription>PHOTOTHERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R300P01-006</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T14:41:38.315Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817770022053</udiDi>
    <basicUdiDi>081777002EyeMax2CU</basicUdiDi>
    <tradeName>EyeMax 2, Regular USA 20/pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Maxtec, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003961</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>V0201</emdnCode>
    <emdnDescription>PHOTOTHERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R300P01-007</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T14:41:38.286Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817770022060</udiDi>
    <basicUdiDi>081777002EyeMax2CU</basicUdiDi>
    <tradeName>EyeMax 2,Drager Regular MP03772 20/pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Maxtec, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003961</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>V0201</emdnCode>
    <emdnDescription>PHOTOTHERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R300P01-008</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T14:41:38.257Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817770022077</udiDi>
    <basicUdiDi>081777002EyeMax2CU</basicUdiDi>
    <tradeName>EyeMax 2, Ecuador Regular 20/Pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Maxtec, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003961</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>V0201</emdnCode>
    <emdnDescription>PHOTOTHERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R300P01-009</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T14:41:38.223Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817770022084</udiDi>
    <basicUdiDi>081777002EyeMax2CU</basicUdiDi>
    <tradeName>EyeMax 2, F&amp;P Preemie 20/pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Maxtec, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003961</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>V0201</emdnCode>
    <emdnDescription>PHOTOTHERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R300P02-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T14:41:38.196Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817770022091</udiDi>
    <basicUdiDi>081777002EyeMax2CU</basicUdiDi>
    <tradeName>EyeMax 2, Mediprema Preemie 20/Pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Maxtec, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003961</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>V0201</emdnCode>
    <emdnDescription>PHOTOTHERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R300P02-002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T14:41:38.166Z</lastUpdated>
  </row>
</eudamedExport>