<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05711117225952</udiDi>
    <basicUdiDi>5711117_P-0000507_RP</basicUdiDi>
    <tradeName>CIR insert earphone</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DGS Diagnostics A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000020570</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149080</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8528954</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:47:26.349Z</lastUpdated>
  </row>
  <row>
    <udiDi>05711117221671</udiDi>
    <basicUdiDi>5711117_P-0000504_RE</basicUdiDi>
    <tradeName>DD45</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DGS Diagnostics A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000020570</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149080</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8010879</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:47:25.550Z</lastUpdated>
  </row>
  <row>
    <udiDi>05711117219586</udiDi>
    <basicUdiDi>5711117_P-0000503_RB</basicUdiDi>
    <tradeName>B-81</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DGS Diagnostics A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000020570</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149080</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8104119</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:47:24.734Z</lastUpdated>
  </row>
  <row>
    <udiDi>05711117192056</udiDi>
    <basicUdiDi>5711117_P-0000502_R8</basicUdiDi>
    <tradeName>B71</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DGS Diagnostics A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000020570</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149080</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8102514</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:47:23.932Z</lastUpdated>
  </row>
  <row>
    <udiDi>05214002308087</udiDi>
    <basicUdiDi>5214002308ENTC0102VZ</basicUdiDi>
    <tradeName>Examination cabinet</tradeName>
    <deviceName>Examination cabinet</deviceName>
    <manufacturerName>ΠΑΠΠΑΣ Ν. &amp; ΣΙΑ ΟΕ</manufacturerName>
    <manufacturerSrn>GR-MF-000016242</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z121402</emdnCode>
    <emdnDescription>ENT TREATMENT UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ENTC0102</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:11:56.675Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060485270775</udiDi>
    <basicUdiDi>506048527GMACCOTOQ2</basicUdiDi>
    <tradeName>05060485270775</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GM Instruments Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020565</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC300-OTS</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:19:47.837Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060485270041</udiDi>
    <basicUdiDi>506048527GMNVRHIN52</basicUdiDi>
    <tradeName>05060485270041</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GM Instruments Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020565</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149008</emdnCode>
    <emdnDescription>RHINOANEMOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NV1-PC</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:19:45.428Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060485270027</udiDi>
    <basicUdiDi>506048527GMA1ACOUFS</basicUdiDi>
    <tradeName>A1 ACOUSTIC RHINOMETER CLINICAL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GM Instruments Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020565</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149009</emdnCode>
    <emdnDescription>RHINOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A1-C</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:19:43.821Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055272701853</udiDi>
    <basicUdiDi>50552727SPECULATV</basicUdiDi>
    <tradeName>DISPOSABLE SPECULA 3.5MM (PK OF 500)</tradeName>
    <deviceName>OTOSCOPE SPECULA</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>MDR 2017/745</legislation>
    <emdnCode>Z12149080</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1501-P-5170</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:40:37.069Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719890209382</udiDi>
    <basicUdiDi>471989020OSCK93XUE</basicUdiDi>
    <tradeName>Fibre Diagnostic Otoscope</tradeName>
    <deviceName>Otoscope</deviceName>
    <manufacturerName>CHIN KOU MEDICAL INSTRUMENT CO., LTD.</manufacturerName>
    <manufacturerSrn>TW-MF-000042725</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK-938</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:32:30.952Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262365080011</udiDi>
    <basicUdiDi>42623650813496452590000JJ</basicUdiDi>
    <tradeName>AT-research</tradeName>
    <deviceName>Audiometers: AT-research, AT2000</deviceName>
    <manufacturerName>AURITEC Medizindiagnostische Systeme GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000023154</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z121401</emdnCode>
    <emdnDescription>AUDIOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10710000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:27:39.791Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719890209399</udiDi>
    <basicUdiDi>471989020OSCK93XUE</basicUdiDi>
    <tradeName>Fibre Diagnostic Otoscope</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CHIN KOU MEDICAL INSTRUMENT CO., LTD.</manufacturerName>
    <manufacturerSrn>TW-MF-000042725</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK-939</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:47:44.929Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719890209405</udiDi>
    <basicUdiDi>471989020OSCK93XUE</basicUdiDi>
    <tradeName>Fibre Diagnostic Otoscope</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CHIN KOU MEDICAL INSTRUMENT CO., LTD.</manufacturerName>
    <manufacturerSrn>TW-MF-000042725</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK-938A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:47:11.498Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719890209412</udiDi>
    <basicUdiDi>471989020OSCK93XUE</basicUdiDi>
    <tradeName>Fibre Diagnostic Otoscope</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CHIN KOU MEDICAL INSTRUMENT CO., LTD.</manufacturerName>
    <manufacturerSrn>TW-MF-000042725</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK-939A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:47:10.776Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719890209429</udiDi>
    <basicUdiDi>471989020OSCK93XUE</basicUdiDi>
    <tradeName>Radiantlite</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CHIN KOU MEDICAL INSTRUMENT CO., LTD.</manufacturerName>
    <manufacturerSrn>TW-MF-000042725</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK-S908</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:47:10.080Z</lastUpdated>
  </row>
  <row>
    <udiDi>04048551196342</udiDi>
    <basicUdiDi>4048551001441TM</basicUdiDi>
    <tradeName>04048551196342</tradeName>
    <deviceName>Probes/Bougies/Dilators</deviceName>
    <manufacturerName>KARL STORZ SE &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005723</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149080</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>745708</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:26:56.485Z</lastUpdated>
  </row>
  <row>
    <udiDi>04048551196502</udiDi>
    <basicUdiDi>4048551001447TZ</basicUdiDi>
    <tradeName>04048551196502</tradeName>
    <deviceName>Probes/Bougies/Dilators</deviceName>
    <manufacturerName>KARL STORZ SE &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005723</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149080</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>745847</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:26:54.202Z</lastUpdated>
  </row>
  <row>
    <udiDi>04035873011422</udiDi>
    <basicUdiDi>4035873120101029S</basicUdiDi>
    <tradeName>OTOSCOPES</tradeName>
    <deviceName>Otoscope</deviceName>
    <manufacturerName>Henke-Sass, Wolf GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005531</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>89550240</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T14:23:02.824Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770025150000</udiDi>
    <basicUdiDi>3770025150LOGAUDIOPODV7</basicUdiDi>
    <tradeName>iAudiogram®</tradeName>
    <deviceName>AudioPod®</deviceName>
    <manufacturerName>MY MEDICAL ASSISTANT</manufacturerName>
    <manufacturerSrn>FR-MF-000019847</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149092</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iAudiogram®</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:06:30.311Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760449430277</udiDi>
    <basicUdiDi>376044943FVAIRE.01DC</basicUdiDi>
    <tradeName>TKM</tradeName>
    <deviceName>FAUTEUIL VESTIBULAIRE</deviceName>
    <manufacturerName>technic kine medicale</manufacturerName>
    <manufacturerSrn>FR-MF-000052186</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12140401</emdnCode>
    <emdnDescription>VESTIBULAR ASSESSMENT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FVAIRE.01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:55:17.387Z</lastUpdated>
  </row>
</eudamedExport>