<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05714464104376</udiDi>
    <basicUdiDi>57144640-HI-00053-RB</basicUdiDi>
    <tradeName>Bernafon</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SBO Hearing A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000001270</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y2145060101</emdnCode>
    <emdnDescription>BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>258712</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:14:42.477Z</lastUpdated>
  </row>
  <row>
    <udiDi>05714464103492</udiDi>
    <basicUdiDi>57144640-HI-00052-R8</basicUdiDi>
    <tradeName>Audika</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SBO Hearing A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000001270</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y2145060101</emdnCode>
    <emdnDescription>BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>258599</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:14:41.664Z</lastUpdated>
  </row>
  <row>
    <udiDi>05713315010798</udiDi>
    <basicUdiDi>5713315NA0002456</basicUdiDi>
    <tradeName>1072 Hi Pro 2</tradeName>
    <deviceName>1072 HI-PRO 2 Hearing Instrument Programmer</deviceName>
    <manufacturerName>Natus Medical Denmark ApS</manufacturerName>
    <manufacturerSrn>DK-MF-000001617</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214599</emdnCode>
    <emdnDescription>HEARING AIDS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-04-14800</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:13:12.985Z</lastUpdated>
  </row>
  <row>
    <udiDi>05713315003301</udiDi>
    <basicUdiDi>5713315NA000885Y</basicUdiDi>
    <tradeName>REM Test tubes, 1.1mm (50 pcs.)</tradeName>
    <deviceName>REM Test tubes, 1.1mm (50 pcs.)</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>Y214599</emdnCode>
    <emdnDescription>HEARING AIDS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-62-35100</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:12:51.374Z</lastUpdated>
  </row>
  <row>
    <udiDi>05713315001192</udiDi>
    <basicUdiDi>5713315NA000875W</basicUdiDi>
    <tradeName>1053 Freefit</tradeName>
    <deviceName>1053 Charger for Freefit</deviceName>
    <manufacturerName>Natus Medical Denmark ApS</manufacturerName>
    <manufacturerSrn>DK-MF-000001617</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214599</emdnCode>
    <emdnDescription>HEARING AIDS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-69-39207</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:12:48.983Z</lastUpdated>
  </row>
  <row>
    <udiDi>05707131332967</udiDi>
    <basicUdiDi>57144640-AC-00034-GH</basicUdiDi>
    <tradeName>Oticon</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SBO Hearing A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000001270</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214580</emdnCode>
    <emdnDescription>HEARING AIDS OR HEARING DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>178509</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:09:36.538Z</lastUpdated>
  </row>
  <row>
    <udiDi>05707131279545</udiDi>
    <basicUdiDi>57144640-DAIA-00046-N4</basicUdiDi>
    <tradeName>SBO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SBO Hearing A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000001270</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214580</emdnCode>
    <emdnDescription>HEARING AIDS OR HEARING DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>142207</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:09:34.935Z</lastUpdated>
  </row>
  <row>
    <udiDi>05707131274618</udiDi>
    <basicUdiDi>57144640-FMA-00043-9X</basicUdiDi>
    <tradeName>SBO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SBO Hearing A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000001270</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214580</emdnCode>
    <emdnDescription>HEARING AIDS OR HEARING DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>142328</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:09:30.930Z</lastUpdated>
  </row>
  <row>
    <udiDi>05707131369345</udiDi>
    <basicUdiDi>57071313-RMIC-00020-8Z</basicUdiDi>
    <tradeName>Oticon</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SBO Hearing A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000001270</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214580</emdnCode>
    <emdnDescription>HEARING AIDS OR HEARING DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>191009</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:59:18.248Z</lastUpdated>
  </row>
  <row>
    <udiDi>05707131369215</udiDi>
    <basicUdiDi>57071313-STR-00041-WY</basicUdiDi>
    <tradeName>Oticon Medical</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SBO Hearing A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000001270</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214580</emdnCode>
    <emdnDescription>HEARING AIDS OR HEARING DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>204557</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:59:14.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>05707131250827</udiDi>
    <basicUdiDi>57071313-PA-00003-KU</basicUdiDi>
    <tradeName>Oticon</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SBO Hearing A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000001270</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214580</emdnCode>
    <emdnDescription>HEARING AIDS OR HEARING DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>127837</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:59:13.439Z</lastUpdated>
  </row>
  <row>
    <udiDi>05700002304735</udiDi>
    <basicUdiDi>57000023047EpiCareQ2</basicUdiDi>
    <tradeName>epi-Care free 4G</tradeName>
    <deviceName>Epi-Care</deviceName>
    <manufacturerName>Danish Care Technology ApS</manufacturerName>
    <manufacturerSrn>DK-MF-000049214</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y215199</emdnCode>
    <emdnDescription>ALARM SYSTEMS + SIGNALING, INDICATION AND REMINDER AIDS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1010082</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:56:28.390Z</lastUpdated>
  </row>
  <row>
    <udiDi>05700002304728</udiDi>
    <basicUdiDi>57000023047EpiCareQ2</basicUdiDi>
    <tradeName>Epi-Care free 868</tradeName>
    <deviceName>Epi-Care</deviceName>
    <manufacturerName>Danish Care Technology ApS</manufacturerName>
    <manufacturerSrn>DK-MF-000049214</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y215199</emdnCode>
    <emdnDescription>ALARM SYSTEMS + SIGNALING, INDICATION AND REMINDER AIDS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1010084</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:48:49.607Z</lastUpdated>
  </row>
  <row>
    <udiDi>05700002278609</udiDi>
    <basicUdiDi>57000022786HekaBesWK</basicUdiDi>
    <tradeName>HEKA Bes</tradeName>
    <deviceName>HEKA Bes</deviceName>
    <manufacturerName>Challenge APS</manufacturerName>
    <manufacturerSrn>DK-MF-000035625</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y214224</emdnCode>
    <emdnDescription>AUGMENTATIVE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HekaBes</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:48:37.591Z</lastUpdated>
  </row>
  <row>
    <udiDi>05600652071813</udiDi>
    <basicUdiDi>56006520718Aidflex87</basicUdiDi>
    <tradeName>Aidflex G9-mk</tradeName>
    <deviceName>Aidflex G9-mk</deviceName>
    <manufacturerName>CAREPATH UNIPESSOAL, LDA</manufacturerName>
    <manufacturerSrn>PT-MF-000048454</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y210924</emdnCode>
    <emdnDescription>ARM SUPPORTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G9-mk</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:21:51.546Z</lastUpdated>
  </row>
  <row>
    <udiDi>05207210000324</udiDi>
    <basicUdiDi>5207210upperlimb99999A3</basicUdiDi>
    <tradeName>HUMERAL BRACE SARMIENTO</tradeName>
    <deviceName>FUNCTIONAL ELBOW BRACE WITH ROM TELESCOPIC AND PALMAR SUPPORT</deviceName>
    <manufacturerName>Α. ΣΑΛΕΜΗΣ &amp; ΣΙΑ ΕΕ - MEDICAL BRACE</manufacturerName>
    <manufacturerSrn>GR-MF-000021796</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y210924</emdnCode>
    <emdnDescription>ARM SUPPORTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MB.2160/M</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:43:24.676Z</lastUpdated>
  </row>
  <row>
    <udiDi>05207210000317</udiDi>
    <basicUdiDi>5207210upperlimb99999A3</basicUdiDi>
    <tradeName>HUMERAL BRACE SARMIENTO</tradeName>
    <deviceName>FUNCTIONAL ELBOW BRACE WITH ROM TELESCOPIC AND PALMAR SUPPORT</deviceName>
    <manufacturerName>Α. ΣΑΛΕΜΗΣ &amp; ΣΙΑ ΕΕ - MEDICAL BRACE</manufacturerName>
    <manufacturerSrn>GR-MF-000021796</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y210924</emdnCode>
    <emdnDescription>ARM SUPPORTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MB.2160/L</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:40:07.080Z</lastUpdated>
  </row>
  <row>
    <udiDi>05065007755044</udiDi>
    <basicUdiDi>5065007755HS449</basicUdiDi>
    <tradeName>Dolphin ScreenReader</tradeName>
    <deviceName>Dolphin ScreenReader</deviceName>
    <manufacturerName>Dolphin Computer Access Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000024252</manufacturerSrn>
    <authorisedRepresentativeName>SENSUS Consulting Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000020337</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y210606</emdnCode>
    <emdnDescription>OCR SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HS4K</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:15:35.271Z</lastUpdated>
  </row>
  <row>
    <udiDi>05065007755020</udiDi>
    <basicUdiDi>5065007755LS44V</basicUdiDi>
    <tradeName>SuperNova Magnifier</tradeName>
    <deviceName>SuperNova Magnifier</deviceName>
    <manufacturerName>Dolphin Computer Access Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000024252</manufacturerSrn>
    <authorisedRepresentativeName>SENSUS Consulting Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000020337</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y210609</emdnCode>
    <emdnDescription>MAGNIFIERS FOR PERSONAL COMPUTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LS4K</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:15:34.150Z</lastUpdated>
  </row>
  <row>
    <udiDi>05065007755013</udiDi>
    <basicUdiDi>5065007755PS45H</basicUdiDi>
    <tradeName>SuperNova Magnifier and Speech</tradeName>
    <deviceName>SuperNova Magnifier &amp; Speech</deviceName>
    <manufacturerName>Dolphin Computer Access Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000024252</manufacturerSrn>
    <authorisedRepresentativeName>SENSUS Consulting Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000020337</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y210606</emdnCode>
    <emdnDescription>OCR SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS4K</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:15:33.348Z</lastUpdated>
  </row>
</eudamedExport>