<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05055272721455</udiDi>
    <basicUdiDi>50552727OTOSCOPESVJ</basicUdiDi>
    <tradeName>LED FIBRE OPTIC OTO. KIT, AA BATTERY</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Keeler Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000009031</manufacturerSrn>
    <authorisedRepresentativeName>Keeler Europe Distribution, S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001559</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1514-P-1275</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-21T18:35:28.435Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055272721462</udiDi>
    <basicUdiDi>50552727OTOSCOPESVJ</basicUdiDi>
    <tradeName>LED PRACTITIONER OTOSCOPE KIT, AA BATTERY</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Keeler Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000009031</manufacturerSrn>
    <authorisedRepresentativeName>Keeler Europe Distribution, S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001559</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1519-P-1004</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-21T18:35:28.415Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055272721530</udiDi>
    <basicUdiDi>50552727OTOSCOPESVJ</basicUdiDi>
    <tradeName>LED FIBRE OPTIC OTO. KIT, LI-ION BATTERY</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Keeler Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000009031</manufacturerSrn>
    <authorisedRepresentativeName>Keeler Europe Distribution, S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001559</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1514-P-1224</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-21T18:35:28.280Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055272721578</udiDi>
    <basicUdiDi>50552727OTOSCOPESVJ</basicUdiDi>
    <tradeName>FIBER OPTIC OTOSCOPE LED HEAD ONLY</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Keeler Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000009031</manufacturerSrn>
    <authorisedRepresentativeName>Keeler Europe Distribution, S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001559</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1519-P-1005</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-21T18:35:28.249Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055272721608</udiDi>
    <basicUdiDi>50552727OTOSCOPESVJ</basicUdiDi>
    <tradeName>PRACTITIONER OTOSCOPE LED HEAD ONLY</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Keeler Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000009031</manufacturerSrn>
    <authorisedRepresentativeName>Keeler Europe Distribution, S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001559</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1514-P-1282</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-21T18:35:28.217Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055272701983</udiDi>
    <basicUdiDi>50552727OTOSCOPESVJ</basicUdiDi>
    <tradeName>3.6V PRACTITIONER OTO HEAD &amp; BULB</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Keeler Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000009031</manufacturerSrn>
    <authorisedRepresentativeName>Keeler Europe Distribution, S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001559</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1513-P-1054</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T07:44:02.325Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055272701990</udiDi>
    <basicUdiDi>50552727OTOSCOPESVJ</basicUdiDi>
    <tradeName>2.8V PRACTITIONER OTO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Keeler Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000009031</manufacturerSrn>
    <authorisedRepresentativeName>Keeler Europe Distribution, S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001559</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1513-P-1062</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-21T07:44:02.307Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055272702027</udiDi>
    <basicUdiDi>50552727OTOSCOPESVJ</basicUdiDi>
    <tradeName>2.8V VISTA FIBRE-OPTIC OTO HEAD &amp; BULB</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Keeler Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000009031</manufacturerSrn>
    <authorisedRepresentativeName>Keeler Europe Distribution, S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001559</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1514-P-1064</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-06-21T07:44:02.280Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055272702034</udiDi>
    <basicUdiDi>50552727OTOSCOPESVJ</basicUdiDi>
    <tradeName>3.6V BULB FIBRE-OPTIC OTOSCOPE (Head Only)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Keeler Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000009031</manufacturerSrn>
    <authorisedRepresentativeName>Keeler Europe Distribution, S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001559</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1514-P-1072</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T07:44:02.257Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055272702041</udiDi>
    <basicUdiDi>50552727OTOSCOPESVJ</basicUdiDi>
    <tradeName>SLIMLINE 2.8V FIBRE-OPTIC OTO IN CASE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Keeler Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000009031</manufacturerSrn>
    <authorisedRepresentativeName>Keeler Europe Distribution, S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001559</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1514-P-1136</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-06-21T07:44:02.237Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055272702058</udiDi>
    <basicUdiDi>50552727OTOSCOPESVJ</basicUdiDi>
    <tradeName>SLIMLINE 3.6V FIBRE-OPTIC OTO IN CASE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Keeler Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000009031</manufacturerSrn>
    <authorisedRepresentativeName>Keeler Europe Distribution, S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001559</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1514-P-1144</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-21T07:44:02.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055272702089</udiDi>
    <basicUdiDi>50552727OTOSCOPESVJ</basicUdiDi>
    <tradeName>2.8V STANDARD OTO IN CARTON</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Keeler Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000009031</manufacturerSrn>
    <authorisedRepresentativeName>Keeler Europe Distribution, S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001559</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1516-P-1025</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-21T07:44:02.196Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055272702119</udiDi>
    <basicUdiDi>50552727OTOSCOPESVJ</basicUdiDi>
    <tradeName>SLIMLINE 2.8V STANDARD OTO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Keeler Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000009031</manufacturerSrn>
    <authorisedRepresentativeName>Keeler Europe Distribution, S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001559</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1518-P-1001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-21T07:44:02.171Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055272702126</udiDi>
    <basicUdiDi>50552727OTOSCOPESVJ</basicUdiDi>
    <tradeName>SLIMLINE 3.6V STANDARD OTO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Keeler Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000009031</manufacturerSrn>
    <authorisedRepresentativeName>Keeler Europe Distribution, S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001559</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1518-P-1002</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-21T07:44:02.149Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055272702133</udiDi>
    <basicUdiDi>50552727OTOSCOPESVJ</basicUdiDi>
    <tradeName>SLIMLINE 2.8V PRACTITIONER OTO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Keeler Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000009031</manufacturerSrn>
    <authorisedRepresentativeName>Keeler Europe Distribution, S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001559</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1519-P-1001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-21T07:44:02.128Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055272702140</udiDi>
    <basicUdiDi>50552727OTOSCOPESVJ</basicUdiDi>
    <tradeName>3.6V PRACTITIONER OTO IN CASE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Keeler Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000009031</manufacturerSrn>
    <authorisedRepresentativeName>Keeler Europe Distribution, S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001559</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1519-P-1002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-21T07:44:02.096Z</lastUpdated>
  </row>
  <row>
    <udiDi>05713315009631</udiDi>
    <basicUdiDi>5713315NA001024Z</basicUdiDi>
    <tradeName>Madsen Zodiac</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Natus Medical Denmark ApS</manufacturerName>
    <manufacturerSrn>DK-MF-000001617</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12149005</emdnCode>
    <emdnDescription>IMPEDANCE METERS FOR THE AUDITORY SYSTEM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-04-16324</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-20T23:24:47.987Z</lastUpdated>
  </row>
  <row>
    <udiDi>05713315009624</udiDi>
    <basicUdiDi>5713315NA001024Z</basicUdiDi>
    <tradeName>Madsen Zodiac</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Natus Medical Denmark ApS</manufacturerName>
    <manufacturerSrn>DK-MF-000001617</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12149005</emdnCode>
    <emdnDescription>IMPEDANCE METERS FOR THE AUDITORY SYSTEM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-04-16323</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-20T23:24:46.803Z</lastUpdated>
  </row>
  <row>
    <udiDi>05713315009617</udiDi>
    <basicUdiDi>5713315NA001024Z</basicUdiDi>
    <tradeName>Madsen Zodiac</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Natus Medical Denmark ApS</manufacturerName>
    <manufacturerSrn>DK-MF-000001617</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12149005</emdnCode>
    <emdnDescription>IMPEDANCE METERS FOR THE AUDITORY SYSTEM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-04-16322</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-20T23:24:45.602Z</lastUpdated>
  </row>
  <row>
    <udiDi>05713315009594</udiDi>
    <basicUdiDi>5713315NA001024Z</basicUdiDi>
    <tradeName>Madsen Zodiac</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Natus Medical Denmark ApS</manufacturerName>
    <manufacturerSrn>DK-MF-000001617</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12149005</emdnCode>
    <emdnDescription>IMPEDANCE METERS FOR THE AUDITORY SYSTEM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-04-16320</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-20T23:24:44.399Z</lastUpdated>
  </row>
</eudamedExport>