<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>
  <row>
    <udiDi>00817770022107</udiDi>
    <basicUdiDi>081777002EyeMax2CU</basicUdiDi>
    <tradeName>EyeMax 2, Preemie 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>R300P02-006</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T14:41:38.137Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817770022114</udiDi>
    <basicUdiDi>081777002EyeMax2CU</basicUdiDi>
    <tradeName>EyeMax 2, Drager Preemie MP03771 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>R300P02-007</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T14:41:38.108Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817770022121</udiDi>
    <basicUdiDi>081777002EyeMax2CU</basicUdiDi>
    <tradeName>EyeMax 2, Ecuador 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>R300P02-008</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T14:41:38.080Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817770022138</udiDi>
    <basicUdiDi>081777002EyeMax2CU</basicUdiDi>
    <tradeName>EyeMax 2, Mediprema 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>R300P03-002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T14:41:38.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817770022145</udiDi>
    <basicUdiDi>081777002EyeMax2CU</basicUdiDi>
    <tradeName>EyeMax 2, Micro 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>R300P03-006</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T14:41:38.016Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817770022152</udiDi>
    <basicUdiDi>081777002EyeMax2CU</basicUdiDi>
    <tradeName>EyeMax 2, Drager Micro MP03770 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>R300P03-007</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T14:41:37.988Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817770022169</udiDi>
    <basicUdiDi>081777002EyeMax2CU</basicUdiDi>
    <tradeName>EyeMax 2, Ecuador 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>R300P03-008</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T14:41:37.947Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817770022411</udiDi>
    <basicUdiDi>081777002EyeMax2CU</basicUdiDi>
    <tradeName>EYEMAX 2, F&amp;P 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>R300P03-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T14:41:37.798Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817770025818</udiDi>
    <basicUdiDi>081777002EyeMax2CU</basicUdiDi>
    <tradeName>EyeMax 2 Micro 20/pack Italian</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>R300P03-004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T14:41:37.706Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817770025825</udiDi>
    <basicUdiDi>081777002EyeMax2CU</basicUdiDi>
    <tradeName>EyeMax 2 Preemie 20/pack Italian</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>R300P02-004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T14:41:37.666Z</lastUpdated>
  </row>
</eudamedExport>