<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08500176511420</udiDi>
    <basicUdiDi>0850017651142SF</basicUdiDi>
    <tradeName>DERMLITE</tradeName>
    <deviceName>DL4/DL200 USB Cable</deviceName>
    <manufacturerName>DermLite LLC</manufacturerName>
    <manufacturerSrn>US-MF-000005170</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040108</emdnCode>
    <emdnDescription>DERMATOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MUSB</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:16:08.114Z</lastUpdated>
  </row>
  <row>
    <udiDi>08500176511284</udiDi>
    <basicUdiDi>0850017651128SM</basicUdiDi>
    <tradeName>DERMLITE</tradeName>
    <deviceName>IceCap for DL4 &amp; Foto X, 100-pack</deviceName>
    <manufacturerName>DermLite LLC</manufacturerName>
    <manufacturerSrn>US-MF-000005170</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040108</emdnCode>
    <emdnDescription>DERMATOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICDL4-100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:16:06.534Z</lastUpdated>
  </row>
  <row>
    <udiDi>08500176511116</udiDi>
    <basicUdiDi>0850017651111S4</basicUdiDi>
    <tradeName>DERMLITE</tradeName>
    <deviceName>IceCap for DL200, 100-pack</deviceName>
    <manufacturerName>DermLite LLC</manufacturerName>
    <manufacturerSrn>US-MF-000005170</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040108</emdnCode>
    <emdnDescription>DERMATOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICDL200-100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:16:05.710Z</lastUpdated>
  </row>
  <row>
    <udiDi>08500176511048</udiDi>
    <basicUdiDi>0850017651104S7</basicUdiDi>
    <tradeName>DERMLITE</tradeName>
    <deviceName>DermLite GL Battery</deviceName>
    <manufacturerName>DermLite LLC</manufacturerName>
    <manufacturerSrn>US-MF-000005170</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040108</emdnCode>
    <emdnDescription>DERMATOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GLB</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:16:04.111Z</lastUpdated>
  </row>
  <row>
    <udiDi>08500176510744</udiDi>
    <basicUdiDi>0850017651074SP</basicUdiDi>
    <tradeName>DERMLITE</tradeName>
    <deviceName>DL200/Lumio S Drawstring Pouch</deviceName>
    <manufacturerName>DermLite LLC</manufacturerName>
    <manufacturerSrn>US-MF-000005170</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040108</emdnCode>
    <emdnDescription>DERMATOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DSP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:16:01.722Z</lastUpdated>
  </row>
  <row>
    <udiDi>08500176510508</udiDi>
    <basicUdiDi>0850017651050S9</basicUdiDi>
    <tradeName>DERMLITE</tradeName>
    <deviceName>MagnetiConnect Adapter - 62 mm</deviceName>
    <manufacturerName>DermLite LLC</manufacturerName>
    <manufacturerSrn>US-MF-000005170</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040108</emdnCode>
    <emdnDescription>DERMATOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DLMC-62</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:16:00.866Z</lastUpdated>
  </row>
  <row>
    <udiDi>08500176510676</udiDi>
    <basicUdiDi>0850017651067SS</basicUdiDi>
    <tradeName>DERMLITE</tradeName>
    <deviceName>MagnetiConnect for Nikon 1 AW1</deviceName>
    <manufacturerName>DermLite LLC</manufacturerName>
    <manufacturerSrn>US-MF-000005170</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040108</emdnCode>
    <emdnDescription>DERMATOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DLMC-N1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:16:00.863Z</lastUpdated>
  </row>
  <row>
    <udiDi>08500176510430</udiDi>
    <basicUdiDi>0850017651043SC</basicUdiDi>
    <tradeName>DERMLITE</tradeName>
    <deviceName>MagnetiConnect Adapter - 52 mm</deviceName>
    <manufacturerName>DermLite LLC</manufacturerName>
    <manufacturerSrn>US-MF-000005170</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040108</emdnCode>
    <emdnDescription>DERMATOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DLMC-52</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:16:00.819Z</lastUpdated>
  </row>
  <row>
    <udiDi>08500176510362</udiDi>
    <basicUdiDi>0850017651036SF</basicUdiDi>
    <tradeName>DERMLITE</tradeName>
    <deviceName>MagnetiConnect Adapter - 37 mm</deviceName>
    <manufacturerName>DermLite LLC</manufacturerName>
    <manufacturerSrn>US-MF-000005170</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040108</emdnCode>
    <emdnDescription>DERMATOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DLMC-37</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:15:53.540Z</lastUpdated>
  </row>
  <row>
    <udiDi>08500176510294</udiDi>
    <basicUdiDi>0850017651029SJ</basicUdiDi>
    <tradeName>DERMLITE</tradeName>
    <deviceName>MagnetiConnect for all phone/tablet adapters</deviceName>
    <manufacturerName>DermLite LLC</manufacturerName>
    <manufacturerSrn>US-MF-000005170</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040108</emdnCode>
    <emdnDescription>DERMATOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DLMC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:15:51.929Z</lastUpdated>
  </row>
  <row>
    <udiDi>08500176510126</udiDi>
    <basicUdiDi>0850017651012RZ</basicUdiDi>
    <tradeName>DERMLITE</tradeName>
    <deviceName>DL2 Silicone Sleeve</deviceName>
    <manufacturerName>DermLite LLC</manufacturerName>
    <manufacturerSrn>US-MF-000005170</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040108</emdnCode>
    <emdnDescription>DERMATOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DLIISS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:15:51.128Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850013533015</udiDi>
    <basicUdiDi>0850013533SYSXXZL</basicUdiDi>
    <tradeName>TrakCare England</tradeName>
    <deviceName>IntelliCare</deviceName>
    <manufacturerName>InterSystems Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000048003</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040192</emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TCENXX</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:11:36.848Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002554580</udiDi>
    <basicUdiDi>0827002CVI022FA</basicUdiDi>
    <tradeName>Charger for Doppler Blood Flow Monitor</tradeName>
    <deviceName>Charger for Doppler Blood Flow Monitor</deviceName>
    <manufacturerName>Cook Vandergrift Inc</manufacturerName>
    <manufacturerSrn>US-MF-000002657</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040111</emdnCode>
    <emdnDescription>BLOOD FLOW METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DP-M350-CHG1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:46:57.515Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002316324</udiDi>
    <basicUdiDi>0827002CVI021F8</basicUdiDi>
    <tradeName>Doppler Blood Flow Monitor Channel/Cable Verifier</tradeName>
    <deviceName>Doppler Blood Flow Monitor Channel/Cable Verifier</deviceName>
    <manufacturerName>Cook Vandergrift Inc</manufacturerName>
    <manufacturerSrn>US-MF-000002657</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040111</emdnCode>
    <emdnDescription>BLOOD FLOW METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DP-MCV01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:46:56.716Z</lastUpdated>
  </row>
  <row>
    <udiDi>00814088020146</udiDi>
    <basicUdiDi>081408802AE-1001027LR</basicUdiDi>
    <tradeName>ivWatch Patient Monitor</tradeName>
    <deviceName>ivWatch Patient Monitor</deviceName>
    <manufacturerName>ivWatch, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000001531</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040192</emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AE-1001022</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:17:49.180Z</lastUpdated>
  </row>
  <row>
    <udiDi>00814088020122</udiDi>
    <basicUdiDi>081408802AE-1001003LB</basicUdiDi>
    <tradeName>ivWatch Extension Module</tradeName>
    <deviceName>ivWatch Extension Module</deviceName>
    <manufacturerName>ivWatch, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000001531</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040192</emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AE-1001003</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:17:48.393Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613389915006</udiDi>
    <basicUdiDi>07613389UTMST4</basicUdiDi>
    <tradeName>SilentCloud Mobile App 1.5.8</tradeName>
    <deviceName>Sonova tinnitus management system</deviceName>
    <manufacturerName>Sonova AG</manufacturerName>
    <manufacturerSrn>CH-MF-000015958</manufacturerSrn>
    <authorisedRepresentativeName>Sonova Deutschland GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006322</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040192</emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>088-0033-00010</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:11:14.613Z</lastUpdated>
  </row>
  <row>
    <udiDi>00763000724610</udiDi>
    <basicUdiDi>0763000B00028438N</basicUdiDi>
    <tradeName>00763000724610</tradeName>
    <deviceName>Samsung Smart MDI</deviceName>
    <manufacturerName>Medtronic MINIMED</manufacturerName>
    <manufacturerSrn>US-PR-000014565</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1204011502</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MMT-5113JWY</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:08:01.584Z</lastUpdated>
  </row>
  <row>
    <udiDi>00763000413484</udiDi>
    <basicUdiDi>0763000B00012167E</basicUdiDi>
    <tradeName>00763000413484</tradeName>
    <deviceName>Guardian 4 Sensor</deviceName>
    <manufacturerName>Medtronic MINIMED</manufacturerName>
    <manufacturerSrn>US-PR-000014565</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1204011502</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MMT-7040D1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:06:09.975Z</lastUpdated>
  </row>
  <row>
    <udiDi>00763000381080</udiDi>
    <basicUdiDi>0763000B00004147D</basicUdiDi>
    <tradeName>00763000381080</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medtronic MINIMED</manufacturerName>
    <manufacturerSrn>US-MF-000023100</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12040180</emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MMT-385</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:06:03.580Z</lastUpdated>
  </row>
</eudamedExport>