<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00379497005899</udiDi>
    <basicUdiDi>0379497ELNAKClCaQL</basicUdiDi>
    <tradeName>EasyLyte Neo Analyzer</tradeName>
    <deviceName>EasyLyte Neo Analyzer</deviceName>
    <manufacturerName>Medica Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000037250</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201040201</emdnCode>
    <emdnDescription>ION SELECTIVE ELECTROLYTE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30030</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:22:23.678Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195226000924</udiDi>
    <basicUdiDi>0195226000924R3</basicUdiDi>
    <tradeName>GEM Premier 7000 with iQM3</tradeName>
    <deviceName>GEM Premier 7000 with iQM3</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201040102</emdnCode>
    <emdnDescription>BLOOD GAS ANALYSERS - WITH ADDITIONAL PARAMETERS (pH, pO2, pCO2, Hct + metabolites + electrolytes, CO-oximeter parameters and coagulation parameters)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00000015279</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:05:25.436Z</lastUpdated>
  </row>
  <row>
    <udiDi>00894472000732</udiDi>
    <basicUdiDi>00894472GD704644</basicUdiDi>
    <tradeName>OPTI CCA -TS2 Blood Gas Analyzer</tradeName>
    <deviceName>OPTI CCA - TS2</deviceName>
    <manufacturerName>OPTI Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027152</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201040101</emdnCode>
    <emdnDescription>BLOOD GAS ANALYSERS - WITH CLASSIC PROFILE (pH, pO2, pCO2, HCT + electrolytes)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GD7046</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:40:09.970Z</lastUpdated>
  </row>
  <row>
    <udiDi>00894472000152</udiDi>
    <basicUdiDi>00894472GD70133M</basicUdiDi>
    <tradeName>OPTI CCA -TS Blood Gas Analyzer</tradeName>
    <deviceName>OPTI CCA- TS</deviceName>
    <manufacturerName>OPTI Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027152</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201040101</emdnCode>
    <emdnDescription>BLOOD GAS ANALYSERS - WITH CLASSIC PROFILE (pH, pO2, pCO2, HCT + electrolytes)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GD7013</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:40:09.173Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EG-MF-000032515KP</udiDi>
    <basicUdiDi>B-EG-MF-000032515KP</basicUdiDi>
    <tradeName>NS Biotec electrolyte analyzer</tradeName>
    <deviceName>electrolyte analyzer</deviceName>
    <manufacturerName>NS BIOTEC</manufacturerName>
    <manufacturerSrn>EG-MF-000032515</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201040201</emdnCode>
    <emdnDescription>ION SELECTIVE ELECTROLYTE ANALYSERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>EA205</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:46:50.330Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47215H2</udiDi>
    <basicUdiDi>B-47215H2</basicUdiDi>
    <tradeName>SPOTCHEM EL (SE-1520)</tradeName>
    <deviceName>SPOTCHEM EL (SE-1520)</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201040201</emdnCode>
    <emdnDescription>ION SELECTIVE ELECTROLYTE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>47215</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:57:48.744Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47214GY</udiDi>
    <basicUdiDi>B-47214GY</basicUdiDi>
    <tradeName>SPOTCHEM EL (SE-1520)</tradeName>
    <deviceName>SPOTCHEM EL (SE-1520)</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201040201</emdnCode>
    <emdnDescription>ION SELECTIVE ELECTROLYTE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>47214</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:57:46.329Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47204GV</udiDi>
    <basicUdiDi>B-47204GV</basicUdiDi>
    <tradeName>SPOTCHEM EL (SE-1520)</tradeName>
    <deviceName>SPOTCHEM EL (SE-1520)</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201040201</emdnCode>
    <emdnDescription>ION SELECTIVE ELECTROLYTE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>47204</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:57:37.526Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972337852205</udiDi>
    <basicUdiDi>B-16972337852205</basicUdiDi>
    <tradeName>16972337852205</tradeName>
    <deviceName>i-Check Cartridge</deviceName>
    <manufacturerName>B&amp;E BIO-TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000023256</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201040185</emdnCode>
    <emdnDescription>BLOOD GAS ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BG3</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:50:11.367Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972337852199</udiDi>
    <basicUdiDi>B-16972337852199</basicUdiDi>
    <tradeName>16972337852199</tradeName>
    <deviceName>i-Check Cartridge</deviceName>
    <manufacturerName>B&amp;E BIO-TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000023256</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201040185</emdnCode>
    <emdnDescription>BLOOD GAS ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BE3</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:50:10.574Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972337852182</udiDi>
    <basicUdiDi>B-16972337852182</basicUdiDi>
    <tradeName>16972337852182</tradeName>
    <deviceName>i-Check Cartridge</deviceName>
    <manufacturerName>B&amp;E BIO-TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000023256</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201040185</emdnCode>
    <emdnDescription>BLOOD GAS ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BG7</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:50:06.562Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972873820235</udiDi>
    <basicUdiDi>B-06972873820235</basicUdiDi>
    <tradeName>06972873820235</tradeName>
    <deviceName>Blood Gas Electrolyte Analyzer</deviceName>
    <manufacturerName>Shenzhen Cornley Bio-Medical Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017322</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201040102</emdnCode>
    <emdnDescription>BLOOD GAS ANALYSERS - WITH ADDITIONAL PARAMETERS (pH, pO2, pCO2, Hct + metabolites + electrolytes, CO-oximeter parameters and coagulation parameters)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Vitagas 5E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:09:20.042Z</lastUpdated>
  </row>
  <row>
    <udiDi>03661540304088</udiDi>
    <basicUdiDi>B-03661540304088</basicUdiDi>
    <tradeName>03661540304088</tradeName>
    <deviceName>ChloroChek® Chloridometer® Sweat Chloride Analyzer</deviceName>
    <manufacturerName>ELITechGroup Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000006942</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201040203</emdnCode>
    <emdnDescription>CHLORIDE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Model 3400</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T14:16:54.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>89061707101336</udiDi>
    <basicUdiDi>890617071AVMAX3JB</basicUdiDi>
    <tradeName>MAXLYTE</tradeName>
    <deviceName>Electrolyte Analyzer</deviceName>
    <manufacturerName>Avecon Healthcare Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000040691</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010499</emdnCode>
    <emdnDescription>BLOOD GAS ANALYSIS / ELECTROLYTE INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Maxlyte 3</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:50:24.437Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806712901152</udiDi>
    <basicUdiDi>8806712POCBGAL002XL</basicUdiDi>
    <tradeName>i-SmartCare 10 Blood Gas Analyzer</tradeName>
    <deviceName>i-SmartCare 10 Blood Gas Analyzer</deviceName>
    <manufacturerName>i-SENS, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009173</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201040101</emdnCode>
    <emdnDescription>BLOOD GAS ANALYSERS - WITH CLASSIC PROFILE (pH, pO2, pCO2, HCT + electrolytes)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCBGAL002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:43:42.660Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806712901091</udiDi>
    <basicUdiDi>8806712POCBGAL001XJ</basicUdiDi>
    <tradeName>i-Smart 300 Blood Gas Analyzer</tradeName>
    <deviceName>i-Smart 300 Blood Gas Analyzer</deviceName>
    <manufacturerName>i-SENS, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009173</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201040101</emdnCode>
    <emdnDescription>BLOOD GAS ANALYSERS - WITH CLASSIC PROFILE (pH, pO2, pCO2, HCT + electrolytes)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCBGAL001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:43:41.043Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806712900926</udiDi>
    <basicUdiDi>8806712POCEAL002EF</basicUdiDi>
    <tradeName>i-Smart 30 PRO Electrolyte Analyzer</tradeName>
    <deviceName>i-Smart 30 PRO Electrolyte Analyzer</deviceName>
    <manufacturerName>i-SENS, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009173</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201040201</emdnCode>
    <emdnDescription>ION SELECTIVE ELECTROLYTE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCEAL002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:43:38.648Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806712900896</udiDi>
    <basicUdiDi>8806712POCEAL001ED</basicUdiDi>
    <tradeName>i-Smart 30 Electrolyte Analyzer</tradeName>
    <deviceName>i-Smart 30 Electrolyte Analyzer</deviceName>
    <manufacturerName>i-SENS, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009173</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201040201</emdnCode>
    <emdnDescription>ION SELECTIVE ELECTROLYTE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCEAL001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:43:36.232Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699226000196</udiDi>
    <basicUdiDi>86992260UCF2011TW</basicUdiDi>
    <tradeName>CFΔ  Collection System</tradeName>
    <deviceName>SWEAT CHLORIDE ANALYZER / TERDE KLOR ANALİZÖRÜ</deviceName>
    <manufacturerName>UTSAT SAĞLIK TEKNOLOJİLERİ SANAYİ TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000016643</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201040203</emdnCode>
    <emdnDescription>CHLORIDE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UCF2011</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T16:09:12.821Z</lastUpdated>
  </row>
  <row>
    <udiDi>08426951293865</udiDi>
    <basicUdiDi>84269512938659Z</basicUdiDi>
    <tradeName>GEM Premier ChemSTAT</tradeName>
    <deviceName>GEM Premier ChemSTAT</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201040102</emdnCode>
    <emdnDescription>BLOOD GAS ANALYSERS - WITH ADDITIONAL PARAMETERS (pH, pO2, pCO2, Hct + metabolites + electrolytes, CO-oximeter parameters and coagulation parameters)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00044000000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:14:06.879Z</lastUpdated>
  </row>
</eudamedExport>