<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>+ENOU1906NOU0A</udiDi>
    <basicUdiDi>B-+ENOU1906NOU0A</basicUdiDi>
    <tradeName>Surgical handpiece 1:1</tradeName>
    <deviceName>Surgical handpiece</deviceName>
    <manufacturerName>NOUVAG AG</manufacturerName>
    <manufacturerSrn>CH-MF-000018882</manufacturerSrn>
    <authorisedRepresentativeName>Nouvag Dental- und Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005643</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12149080</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1906nou</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:04:11.667Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENOU1905NOU09</udiDi>
    <basicUdiDi>B-+ENOU1905NOU09</basicUdiDi>
    <tradeName>Surgical handpiece 1:1</tradeName>
    <deviceName>Surgical handpiece</deviceName>
    <manufacturerName>NOUVAG AG</manufacturerName>
    <manufacturerSrn>CH-MF-000018882</manufacturerSrn>
    <authorisedRepresentativeName>Nouvag Dental- und Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005643</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12149080</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1905nou</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:04:07.647Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENOU1904NOU08</udiDi>
    <basicUdiDi>B-+ENOU1904NOU08</basicUdiDi>
    <tradeName>Surgical handpiece 1:1</tradeName>
    <deviceName>Surgical handpiece</deviceName>
    <manufacturerName>NOUVAG AG</manufacturerName>
    <manufacturerSrn>CH-MF-000018882</manufacturerSrn>
    <authorisedRepresentativeName>Nouvag Dental- und Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005643</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12149080</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1904nou</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:04:06.847Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENOU1903NOU07</udiDi>
    <basicUdiDi>B-+ENOU1903NOU07</basicUdiDi>
    <tradeName>Surgical handpiece 1:1</tradeName>
    <deviceName>Surgical handpiece</deviceName>
    <manufacturerName>NOUVAG AG</manufacturerName>
    <manufacturerSrn>CH-MF-000018882</manufacturerSrn>
    <authorisedRepresentativeName>Nouvag Dental- und Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005643</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12149080</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1903nou</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:04:06.051Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENOU1710NOU03</udiDi>
    <basicUdiDi>B-+ENOU1710NOU03</basicUdiDi>
    <tradeName>Surgical handpiece 1:1</tradeName>
    <deviceName>Surgical handpiece</deviceName>
    <manufacturerName>NOUVAG AG</manufacturerName>
    <manufacturerSrn>CH-MF-000018882</manufacturerSrn>
    <authorisedRepresentativeName>Nouvag Dental- und Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005643</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12149080</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1710nou</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:04:05.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057507851606</udiDi>
    <basicUdiDi>805750785P28FZ12149002ZP</basicUdiDi>
    <tradeName>pro 28F</tradeName>
    <deviceName>Pro28F</deviceName>
    <manufacturerName>Puma Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000047643</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149002</emdnCode>
    <emdnDescription>AUDIOMETRIC CHAMBERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>pro 28F</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:08:58.202Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973574190085</udiDi>
    <basicUdiDi>697357419NP01PB</basicUdiDi>
    <tradeName>Earwax removal and ear examination tools</tradeName>
    <deviceName>Earwax removal and ear examination tools</deviceName>
    <manufacturerName>Wudao Pu (Shenzhen) Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000056790</manufacturerSrn>
    <authorisedRepresentativeName>Debao International GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000046097</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:09:09.205Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971355353063</udiDi>
    <basicUdiDi>697135535305694</basicUdiDi>
    <tradeName>Single Use Sheath</tradeName>
    <deviceName>Single Use Sheath</deviceName>
    <manufacturerName>Shenzhen Besdata Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000018921</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149085</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SH-BS001</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:59:50.159Z</lastUpdated>
  </row>
  <row>
    <udiDi>05711117227550</udiDi>
    <basicUdiDi>5711117_P-0000498_SY</basicUdiDi>
    <tradeName>Sanibel REM Probe Tubes</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DGS Diagnostics A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000020570</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149085</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8533301</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:07:05.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>05711117221053</udiDi>
    <basicUdiDi>5711117_P-0000500_R2</basicUdiDi>
    <tradeName>Sanibel Infant EarCup Hydrogel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DGS Diagnostics A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000020570</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12140385</emdnCode>
    <emdnDescription>EVOKED POTENTIAL AUDIOMETRY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8522011</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:07:05.288Z</lastUpdated>
  </row>
  <row>
    <udiDi>05711117199659</udiDi>
    <basicUdiDi>5711117_P-0000495_SP</basicUdiDi>
    <tradeName>Sanibel Pediatric OAE  foam ear tips</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DGS Diagnostics A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000020570</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149085</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8102682</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:07:03.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>05711117180572</udiDi>
    <basicUdiDi>5711117_P-0000496_SS</basicUdiDi>
    <tradeName>Sanibel TM Electrode</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DGS Diagnostics A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000020570</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12140385</emdnCode>
    <emdnDescription>EVOKED POTENTIAL AUDIOMETRY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8049550</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:07:02.248Z</lastUpdated>
  </row>
  <row>
    <udiDi>05711117095913</udiDi>
    <basicUdiDi>5711117_P-0000508_RS</basicUdiDi>
    <tradeName>Sanibel Pinch clip cables</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DGS Diagnostics A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000020570</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12140380</emdnCode>
    <emdnDescription>EVOKED POTENTIAL AUDIOMETRY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8500390</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:06:56.892Z</lastUpdated>
  </row>
  <row>
    <udiDi>05711117026504</udiDi>
    <basicUdiDi>5711117_P-0000501_R5</basicUdiDi>
    <tradeName>Sanibel Assortment Box BET25</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DGS Diagnostics A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000020570</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149085</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8012838</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:06:55.300Z</lastUpdated>
  </row>
  <row>
    <udiDi>00860003469811</udiDi>
    <basicUdiDi>08600034698hearTestMR</basicUdiDi>
    <tradeName>hearTest</tradeName>
    <deviceName>hearTest</deviceName>
    <manufacturerName>hearX SA (Pty) Ltd</manufacturerName>
    <manufacturerSrn>ZA-MF-000031452</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z121401</emdnCode>
    <emdnDescription>AUDIOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>hearTest (audiometer)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:50:41.346Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971355353070</udiDi>
    <basicUdiDi>697135535305694</basicUdiDi>
    <tradeName>Single Use Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Besdata Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000018921</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149085</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SH-BS002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:44:57.767Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971355353087</udiDi>
    <basicUdiDi>697135535305694</basicUdiDi>
    <tradeName>Single Use Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Besdata Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000018921</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149085</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SH-BS003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:44:57.115Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971355353094</udiDi>
    <basicUdiDi>697135535305694</basicUdiDi>
    <tradeName>Single Use Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Besdata Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000018921</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149085</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SH-BS004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:44:56.522Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851289007330</udiDi>
    <basicUdiDi>0851289007DE508QR</basicUdiDi>
    <tradeName>00851289007330</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Firefly Global</manufacturerName>
    <manufacturerSrn>US-MF-000020015</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DE508</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:34:29.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851289007101</udiDi>
    <basicUdiDi>0851289007DE570QW</basicUdiDi>
    <tradeName>00851289007101</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Firefly Global</manufacturerName>
    <manufacturerSrn>US-MF-000020015</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DE570</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:34:02.792Z</lastUpdated>
  </row>
</eudamedExport>