<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05055445928759</udiDi>
    <basicUdiDi>50554459DIAGNOSTUV</basicUdiDi>
    <tradeName>Apollo Standard Otoscope Set Complete With Reusable Speculum of Ø 2.5 mm, Ø 3.5 mm, Ø 4.5 mm, Ø 5.5 mm and Ø 9.0 mm and Spare Bulb</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surtex Instruments Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI-742-00</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-19T05:35:55.662Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055445928742</udiDi>
    <basicUdiDi>50554459DIAGNOSTUV</basicUdiDi>
    <tradeName>Apollo Standard Universal EENT Diagnostic Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surtex Instruments Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI-740-00</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-19T05:35:54.779Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055445928728</udiDi>
    <basicUdiDi>50554459DIAGNOSTUV</basicUdiDi>
    <tradeName>Corona Premium Otoscope Set Include 7 Each Specula of 2.5 mm and 4.0 mm and 1 Spare Bulb Packed in Hard Case</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surtex Instruments Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI-732-00</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-19T05:35:53.862Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055445928711</udiDi>
    <basicUdiDi>50554459DIAGNOSTUV</basicUdiDi>
    <tradeName>Corona Premium EENT Diagnostic Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surtex Instruments Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI-730-00</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-19T05:35:52.961Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055272717960</udiDi>
    <basicUdiDi>50552727SPECULATV</basicUdiDi>
    <tradeName>TUBE OF DISPOSABLE SPECULA</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>Z12149080</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1513-P-5020</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-06-19T04:15:50.006Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055272717892</udiDi>
    <basicUdiDi>50552727SPECULATV</basicUdiDi>
    <tradeName>DISPOSABLE SPECULA 5.5MM (PK OF 100)</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>Z12149080</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1501-P-5330</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-06-19T04:15:48.167Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055272717885</udiDi>
    <basicUdiDi>50552727SPECULATV</basicUdiDi>
    <tradeName>DISPOSABLE SPECULA 4.5MM (PK OF 100)</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>Z12149080</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1501-P-5322</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-06-19T04:15:47.277Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055272717878</udiDi>
    <basicUdiDi>50552727SPECULATV</basicUdiDi>
    <tradeName>DISPOSABLE SPECULA 3.5MM (PK OF 100)</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>Z12149080</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1501-P-5314</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-06-19T04:15:46.365Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055272717861</udiDi>
    <basicUdiDi>50552727SPECULATV</basicUdiDi>
    <tradeName>DISPOSABLE SPECULA 2.5MM (PK OF 100)</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>Z12149080</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1501-P-5306</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-06-19T04:15:45.492Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055272716734</udiDi>
    <basicUdiDi>50552727SPECULATV</basicUdiDi>
    <tradeName>JAZZ 2MM SPECULUM (PK of 100)</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>Z12149080</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1514-P-7087</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-06-19T04:14:51.656Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055272713344</udiDi>
    <basicUdiDi>50552727SPECULATV</basicUdiDi>
    <tradeName>JAZZ 2.5MM/4.0MM DISPOSABLE SPECULUM (PK - 5 of EACH)</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>Z12149080</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1514-P-7132</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-06-19T04:11:32.465Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055272713337</udiDi>
    <basicUdiDi>50552727SPECULATV</basicUdiDi>
    <tradeName>JAZZ 5MM SPECULUM (PK of 100)</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>Z12149080</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1514-P-7124</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-06-19T04:11:31.556Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055272713320</udiDi>
    <basicUdiDi>50552727SPECULATV</basicUdiDi>
    <tradeName>JAZZ 4MM SPECULUM (PK of 100)</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>Z12149080</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1514-P-7116</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-06-19T04:11:30.708Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055272713313</udiDi>
    <basicUdiDi>50552727SPECULATV</basicUdiDi>
    <tradeName>JAZZ 3MM SPECULUM (PK of 100)</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>Z12149080</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1514-P-7108</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-06-19T04:11:29.759Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055272713306</udiDi>
    <basicUdiDi>50552727SPECULATV</basicUdiDi>
    <tradeName>JAZZ 2.5MM SPECULUM (PK of 100)</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>Z12149080</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1514-P-7095</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-06-19T04:11:28.893Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055272713238</udiDi>
    <basicUdiDi>50552727OTOSCOPESVJ</basicUdiDi>
    <tradeName>JAZZ BULB OTOSCOPE SET</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-1179</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-19T04:11:27.123Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055272703017</udiDi>
    <basicUdiDi>50552727SPECULATV</basicUdiDi>
    <tradeName>SPECULA DISPENSER UNIT</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>Z12149080</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1964-P-2000</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-06-19T04:07:44.513Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055272702294</udiDi>
    <basicUdiDi>50552727SPECULATV</basicUdiDi>
    <tradeName>SET OF PERMANENT SPECULA</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>Z12149080</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1599-P-7229</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-06-19T04:07:12.101Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055272702003</udiDi>
    <basicUdiDi>50552727SPECULATV</basicUdiDi>
    <tradeName>"DISPOSABLE SPECULA 6X 3.5MM/6X 5.5MM (PK OF 12)"</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>Z12149080</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1513-P-7026</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-06-19T04:06:51.554Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055272701969</udiDi>
    <basicUdiDi>50552727SPECULATV</basicUdiDi>
    <tradeName>SPECULUM NO.5 REUSABLE 8.0MM</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>Z12149080</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1512-P-7040</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-06-19T04:06:47.953Z</lastUpdated>
  </row>
</eudamedExport>