<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00850018561099</udiDi>
    <basicUdiDi>0850018561Therapy1B2</basicUdiDi>
    <tradeName>Wee Sight Transilluminator</tradeName>
    <deviceName>Wee Sight Transilluminator</deviceName>
    <manufacturerName>International Biomedical</manufacturerName>
    <manufacturerSrn>US-MF-000017330</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W0202030202</emdnCode>
    <emdnDescription>TRANSILLUMINATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>989805603761</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:18:45.367Z</lastUpdated>
  </row>
  <row>
    <udiDi>10812594013079</udiDi>
    <basicUdiDi>081259401N55500MV</basicUdiDi>
    <tradeName>NeoGlo® Disposable Transilluminator - White Lights</tradeName>
    <deviceName>NeoGlo® Disposable</deviceName>
    <manufacturerName>Neotech Products LLC</manufacturerName>
    <manufacturerSrn>US-MF-000001895</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W0202030202</emdnCode>
    <emdnDescription>TRANSILLUMINATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N5536WH</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:14:28.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812594012594</udiDi>
    <basicUdiDi>081259401N55100M9</basicUdiDi>
    <tradeName>NeoGlo® Blue Transilluminator</tradeName>
    <deviceName>NeoGlo®</deviceName>
    <manufacturerName>Neotech Products LLC</manufacturerName>
    <manufacturerSrn>US-MF-000001895</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W0202030202</emdnCode>
    <emdnDescription>TRANSILLUMINATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N555BL</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:12:36.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>09354330000577</udiDi>
    <basicUdiDi>B-09354330000577</basicUdiDi>
    <tradeName>STARGEL10 SATELLITE READER</tradeName>
    <deviceName>STARGEL10 SATELLITE READER</deviceName>
    <manufacturerName>Haemokinesis Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000033867</manufacturerSrn>
    <authorisedRepresentativeName>Compliance Management Solutions Europe LTD</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BG-AR-000020809</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0202030201</emdnCode>
    <emdnDescription>IMMUNOHEMATOLOGY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GT2015</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:50:18.577Z</lastUpdated>
  </row>
  <row>
    <udiDi>10812594013086</udiDi>
    <basicUdiDi>081259401N55500MV</basicUdiDi>
    <tradeName>NeoGlo® Disposable Transilluminator - Red Lights</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Neotech Products LLC</manufacturerName>
    <manufacturerSrn>US-MF-000001895</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W0202030202</emdnCode>
    <emdnDescription>TRANSILLUMINATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N5536RD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:37:50.799Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195893880973</udiDi>
    <basicUdiDi>B-00195893880973</basicUdiDi>
    <tradeName>Veinlite EMSPRO</tradeName>
    <deviceName>VeinLite EMSPRO</deviceName>
    <manufacturerName>Translite, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000029360</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>W0202030202</emdnCode>
    <emdnDescription>TRANSILLUMINATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VEMSPRO</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:08:26.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195893754281</udiDi>
    <basicUdiDi>B-00195893754281</basicUdiDi>
    <tradeName>Veinlite LEDX</tradeName>
    <deviceName>Veinlite LEDX</deviceName>
    <manufacturerName>Translite, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000029360</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>W0202030202</emdnCode>
    <emdnDescription>TRANSILLUMINATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VLEDX</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:08:25.629Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195893452019</udiDi>
    <basicUdiDi>B-00195893452019</basicUdiDi>
    <tradeName>Veinlite LED+</tradeName>
    <deviceName>Veinlite LED+</deviceName>
    <manufacturerName>Translite, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000029360</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>W0202030202</emdnCode>
    <emdnDescription>TRANSILLUMINATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VLED+</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:08:21.627Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195893253494</udiDi>
    <basicUdiDi>B-00195893253494</basicUdiDi>
    <tradeName>Veinlite PEDI2</tradeName>
    <deviceName>VeinLite PEDI2</deviceName>
    <manufacturerName>Translite, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000029360</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>W0202030202</emdnCode>
    <emdnDescription>TRANSILLUMINATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VPEDI2</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:08:15.231Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195893005314</udiDi>
    <basicUdiDi>B-00195893005314</basicUdiDi>
    <tradeName>Veinlite NEO</tradeName>
    <deviceName>Veinlite NEO</deviceName>
    <manufacturerName>Translite, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000029360</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>W0202030202</emdnCode>
    <emdnDescription>TRANSILLUMINATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VNEO</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:08:11.227Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436583730959</udiDi>
    <basicUdiDi>843658373DGREADERNET77</basicUdiDi>
    <tradeName>DG Reader Net</tradeName>
    <deviceName>DG Reader Net</deviceName>
    <manufacturerName>Diagnostic Grifols, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000784</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202030201</emdnCode>
    <emdnDescription>IMMUNOHEMATOLOGY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>210700</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:45:09.103Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975068491005</udiDi>
    <basicUdiDi>6975068492010020T8</basicUdiDi>
    <tradeName>Dry Fluoroimmunoassay Analyzer</tradeName>
    <deviceName>Dry Fluoroimmunoassay Analyzer</deviceName>
    <manufacturerName>WWHS Biotech.Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000027179</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202030201</emdnCode>
    <emdnDescription>IMMUNOHEMATOLOGY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP088.B1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:03:27.719Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975068490251</udiDi>
    <basicUdiDi>6975068492010010T5</basicUdiDi>
    <tradeName>Dry Fluoroimmunoassay Analyzer</tradeName>
    <deviceName>Dry Fluoroimmunoassay Analyzer</deviceName>
    <manufacturerName>WWHS Biotech.Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000027179</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202030201</emdnCode>
    <emdnDescription>IMMUNOHEMATOLOGY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP011.B1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:03:23.737Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973596010507</udiDi>
    <basicUdiDi>697359601Neo-VistaCJ</basicUdiDi>
    <tradeName>Neo-Vista</tradeName>
    <deviceName>Neo-Vista</deviceName>
    <manufacturerName>Conlett Technology Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000002101</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W0202030202</emdnCode>
    <emdnDescription>TRANSILLUMINATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRANS1</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:47:57.499Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973596010200</udiDi>
    <basicUdiDi>697359601VistaPlusF4</basicUdiDi>
    <tradeName>Vista Plus</tradeName>
    <deviceName>Vista Plus</deviceName>
    <manufacturerName>Conlett Technology Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000002101</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W0202030202</emdnCode>
    <emdnDescription>TRANSILLUMINATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRANS2</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:47:44.694Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812594012679</udiDi>
    <basicUdiDi>081259401N55100M9</basicUdiDi>
    <tradeName>NeoGlo® Aqua Transilluminator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Neotech Products LLC</manufacturerName>
    <manufacturerSrn>US-MF-000001895</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W0202030202</emdnCode>
    <emdnDescription>TRANSILLUMINATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N555AQ</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-19T19:48:48.964Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812594012662</udiDi>
    <basicUdiDi>081259401N55100M9</basicUdiDi>
    <tradeName>NeoGlo® Bright Pink Transilluminator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Neotech Products LLC</manufacturerName>
    <manufacturerSrn>US-MF-000001895</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W0202030202</emdnCode>
    <emdnDescription>TRANSILLUMINATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N555BP</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-19T19:48:40.912Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812594012617</udiDi>
    <basicUdiDi>081259401N55100M9</basicUdiDi>
    <tradeName>NeoGlo® Rose Transilluminator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Neotech Products LLC</manufacturerName>
    <manufacturerSrn>US-MF-000001895</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W0202030202</emdnCode>
    <emdnDescription>TRANSILLUMINATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N5555PK</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-19T19:48:40.157Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812594012686</udiDi>
    <basicUdiDi>081259401N55100M9</basicUdiDi>
    <tradeName>NeoGlo® Violet Transilluminator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Neotech Products LLC</manufacturerName>
    <manufacturerSrn>US-MF-000001895</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W0202030202</emdnCode>
    <emdnDescription>TRANSILLUMINATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N555VL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-19T19:48:36.003Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812594012655</udiDi>
    <basicUdiDi>081259401N55100M9</basicUdiDi>
    <tradeName>NeoGlo® White Transilluminator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Neotech Products LLC</manufacturerName>
    <manufacturerSrn>US-MF-000001895</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W0202030202</emdnCode>
    <emdnDescription>TRANSILLUMINATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N555WH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-19T19:48:35.595Z</lastUpdated>
  </row>
</eudamedExport>