<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00850008829581</udiDi>
    <basicUdiDi>0850008829KeplerianLVC3</basicUdiDi>
    <tradeName>OCUTECH® VES®-Explorer 4x BIOPTIC TELESCOPE SYSTEM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ocutech, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000047026</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y210321</emdnCode>
    <emdnDescription>FAR SIGHTEDNESS TELESCOPIC SYSTEMS/SPECTACLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A2504</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:24:11.580Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850008829611</udiDi>
    <basicUdiDi>0850008829KeplerianLVC3</basicUdiDi>
    <tradeName>OCUTECH® VES®-Sport II 4x BIOPTIC TELESCOPE SYSTEM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ocutech, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000047026</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y210321</emdnCode>
    <emdnDescription>FAR SIGHTEDNESS TELESCOPIC SYSTEMS/SPECTACLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A5204</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:24:11.555Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850008829628</udiDi>
    <basicUdiDi>0850008829KeplerianLVC3</basicUdiDi>
    <tradeName>OCUTECH® VES®-Sport II 5x BIOPTIC TELESCOPE SYSTEM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ocutech, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000047026</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y210321</emdnCode>
    <emdnDescription>FAR SIGHTEDNESS TELESCOPIC SYSTEMS/SPECTACLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A5205</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:24:11.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850008829635</udiDi>
    <basicUdiDi>0850008829KeplerianLVC3</basicUdiDi>
    <tradeName>OCUTECH® VES®-Sport II 6x BIOPTIC TELESCOPE SYSTEM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ocutech, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000047026</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y210321</emdnCode>
    <emdnDescription>FAR SIGHTEDNESS TELESCOPIC SYSTEMS/SPECTACLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A5206</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:24:11.535Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850008829642</udiDi>
    <basicUdiDi>0850008829GalileanC49J</basicUdiDi>
    <tradeName>OCUTECH® SightScope 1,7x BIOPTIC TELESCOPE SYSTEM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ocutech, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000047026</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y210321</emdnCode>
    <emdnDescription>FAR SIGHTEDNESS TELESCOPIC SYSTEMS/SPECTACLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A7017</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:24:11.523Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850008829673</udiDi>
    <basicUdiDi>0850008829GalileanC49J</basicUdiDi>
    <tradeName>OCUTECH® SightScope 2,2x BIOPTIC TELESCOPE SYSTEM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ocutech, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000047026</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y210321</emdnCode>
    <emdnDescription>FAR SIGHTEDNESS TELESCOPIC SYSTEMS/SPECTACLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A7022</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:24:11.514Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850008829703</udiDi>
    <basicUdiDi>0850008829GalileanC49J</basicUdiDi>
    <tradeName>OCUTECH® InstaMount/Reveal FE 0,5x BIOPTIC TELESCOPE SYSTEM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ocutech, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000047026</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y210321</emdnCode>
    <emdnDescription>FAR SIGHTEDNESS TELESCOPIC SYSTEMS/SPECTACLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A7225</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:24:11.504Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850008829710</udiDi>
    <basicUdiDi>0850008829GalileanC49J</basicUdiDi>
    <tradeName>OCUTECH® InstaMount/Reveal TS 2,2x BIOPTIC TELESCOPE SYSTEM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ocutech, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000047026</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y210321</emdnCode>
    <emdnDescription>FAR SIGHTEDNESS TELESCOPIC SYSTEMS/SPECTACLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A7234</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:24:11.487Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850008829765</udiDi>
    <basicUdiDi>0850008829GalileanC49J</basicUdiDi>
    <tradeName>OCUTECH® SightScope NearView BIOPTIC TELESCOPE SYSTEM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ocutech, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000047026</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y210321</emdnCode>
    <emdnDescription>FAR SIGHTEDNESS TELESCOPIC SYSTEMS/SPECTACLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A7017.NV</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:24:11.463Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850008829819</udiDi>
    <basicUdiDi>0850008829KeplerianLVC3</basicUdiDi>
    <tradeName>OCUTECH® VES®-Mini 3x BIOPTIC TELESCOPE SYSTEM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ocutech, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000047026</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y210321</emdnCode>
    <emdnDescription>FAR SIGHTEDNESS TELESCOPIC SYSTEMS/SPECTACLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A3003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:24:11.427Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850008997082</udiDi>
    <basicUdiDi>0850008997CHFSXT</basicUdiDi>
    <tradeName>myCordella System Pack - Dutch</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Endotronix, Inc.</manufacturerName>
    <manufacturerSrn>US-PR-000023160</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12039099</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS TO SUPPORT AND MONITOR VITAL SIGNS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100366-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:24:11.406Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850008997099</udiDi>
    <basicUdiDi>0850008997CHFSXT</basicUdiDi>
    <tradeName>myCordella System Pack - German</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Endotronix, Inc.</manufacturerName>
    <manufacturerSrn>US-PR-000023160</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12039099</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS TO SUPPORT AND MONITOR VITAL SIGNS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100366-03</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:24:11.389Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850010298177</udiDi>
    <basicUdiDi>0850010298COR500MG</basicUdiDi>
    <tradeName>CORE 500 Digital Stethoscope - Earpiece</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Eko Health, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034386</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C9005</emdnCode>
    <emdnDescription>PHONENDOSCOPES AND STETHOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAC500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:24:11.185Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850010298245</udiDi>
    <basicUdiDi>0850010298COR500MG</basicUdiDi>
    <tradeName>CORE 500 Digital Stethoscope - Earpiece</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Eko Health, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034386</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C9005</emdnCode>
    <emdnDescription>PHONENDOSCOPES AND STETHOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAC500_FBL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:24:11.173Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850010298252</udiDi>
    <basicUdiDi>0850010298COR500MG</basicUdiDi>
    <tradeName>CORE 500 Digital Stethoscope - Earpiece</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Eko Health, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034386</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C9005</emdnCode>
    <emdnDescription>PHONENDOSCOPES AND STETHOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAC500_FGR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:24:11.161Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850010298269</udiDi>
    <basicUdiDi>0850010298COR500MG</basicUdiDi>
    <tradeName>CORE 500 Digital Stethoscope - Earpiece</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Eko Health, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034386</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C9005</emdnCode>
    <emdnDescription>PHONENDOSCOPES AND STETHOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAC500_FMA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:24:11.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850010298276</udiDi>
    <basicUdiDi>0850010298COR500MG</basicUdiDi>
    <tradeName>CORE 500 Digital Stethoscope - Earpiece</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Eko Health, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034386</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C9005</emdnCode>
    <emdnDescription>PHONENDOSCOPES AND STETHOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAC500_FSA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:24:11.110Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850010298283</udiDi>
    <basicUdiDi>0850010298COR500MG</basicUdiDi>
    <tradeName>CORE 500 Digital Stethoscope - Chestpiece</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Eko Health, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034386</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C9005</emdnCode>
    <emdnDescription>PHONENDOSCOPES AND STETHOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COR500_Black</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:24:11.096Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850010298306</udiDi>
    <basicUdiDi>0850010298COR500MG</basicUdiDi>
    <tradeName>CORE 500 Digital Stethoscope - Earpiece</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Eko Health, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034386</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C9005</emdnCode>
    <emdnDescription>PHONENDOSCOPES AND STETHOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAC500_FRB</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:24:11.083Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850010298313</udiDi>
    <basicUdiDi>0850010298COR500MG</basicUdiDi>
    <tradeName>CORE 500 Digital Stethoscope - Earpiece</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Eko Health, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034386</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C9005</emdnCode>
    <emdnDescription>PHONENDOSCOPES AND STETHOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAC500_FMO</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:24:11.073Z</lastUpdated>
  </row>
</eudamedExport>