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<eudamedExport entity="devices">
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    <udiDi>00860010246207</udiDi>
    <basicUdiDi>08600102462BBIITRI001AN</basicUdiDi>
    <tradeName>FIAPresto  FIAVet</tradeName>
    <deviceName>Time-resolved immunofluorescence analyzer</deviceName>
    <manufacturerName>Bifour Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034957</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020192</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIAPresto™, FIAPresto™II, FIAPresto™III， FIAVet™, FIAVet™II, FIAVet™III (Bifour/Vetfor)</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:53:10.356Z</lastUpdated>
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    <udiDi>00860008666390</udiDi>
    <basicUdiDi>08600086663URAR024Z</basicUdiDi>
    <tradeName>HTI CL-500</tradeName>
    <deviceName>HTI CL-500</deviceName>
    <manufacturerName>High Technology Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000036184</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W020101020101</emdnCode>
    <emdnDescription>URINE STRIP READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL-500</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:52:39.140Z</lastUpdated>
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  <row>
    <udiDi>00860008666383</udiDi>
    <basicUdiDi>08600086663URAR014X</basicUdiDi>
    <tradeName>HTI CL-50 Plus</tradeName>
    <deviceName>HTI CL-50 Plus</deviceName>
    <manufacturerName>High Technology Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000036184</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W020101020101</emdnCode>
    <emdnDescription>URINE STRIP READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL-50</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:52:38.351Z</lastUpdated>
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    <udiDi>00860000930987</udiDi>
    <basicUdiDi>086000093099000011UM</basicUdiDi>
    <tradeName>BeVigilant™ Reader</tradeName>
    <deviceName>BeVigilant™ Reader</deviceName>
    <manufacturerName>Vigilant Biosciences, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013534</manufacturerSrn>
    <authorisedRepresentativeName>Vigilant Biosciences GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000028648</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020201</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9000011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:50:08.510Z</lastUpdated>
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  <row>
    <udiDi>00860000930963</udiDi>
    <basicUdiDi>086000093099000002UL</basicUdiDi>
    <tradeName>BeVigilant™ Reader</tradeName>
    <deviceName>BeVigilant™ Reader</deviceName>
    <manufacturerName>Vigilant Biosciences, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013534</manufacturerSrn>
    <authorisedRepresentativeName>Vigilant Biosciences GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000028648</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020201</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9000002</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:50:07.678Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850050841005</udiDi>
    <basicUdiDi>086000093094000005S5</basicUdiDi>
    <tradeName>OraFusion Software</tradeName>
    <deviceName>OraFusion Software</deviceName>
    <manufacturerName>Vigilant Biosciences, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013534</manufacturerSrn>
    <authorisedRepresentativeName>Vigilant Biosciences GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000028648</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069082</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4000005</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:48:38.789Z</lastUpdated>
  </row>
  <row>
    <udiDi>30850076346103</udiDi>
    <basicUdiDi>0850076346Lumini-CET</basicUdiDi>
    <tradeName>CLIA-go Pro Chemiluminescence Immunoassay Analyzer</tradeName>
    <deviceName>CLIA-go Pro Chemiluminescence Immunoassay Analyzer</deviceName>
    <manufacturerName>Healgen Life Science LLC</manufacturerName>
    <manufacturerSrn>US-MF-000043017</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>W0201020299</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GR-036</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:36:48.676Z</lastUpdated>
  </row>
  <row>
    <udiDi>10850076346598</udiDi>
    <basicUdiDi>0850076346OG-G260C6J</basicUdiDi>
    <tradeName>Multi-channel Immunofluorescence Analyzer</tradeName>
    <deviceName>Multi-channel Immunofluorescence Analyzer</deviceName>
    <manufacturerName>Healgen Life Science LLC</manufacturerName>
    <manufacturerSrn>US-MF-000043017</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>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OG-G260C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:36:33.730Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816879023046</udiDi>
    <basicUdiDi>081687902NOVACCKX</basicUdiDi>
    <tradeName>Wash Buffer</tradeName>
    <deviceName>NOVEOS® Immunoassay System Accessories</deviceName>
    <manufacturerName>Hycor Biomedical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000031449</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63165</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:23:22.757Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816879022995</udiDi>
    <basicUdiDi>081687902NOVINST37</basicUdiDi>
    <tradeName>NOVEOS® Immunoassay System</tradeName>
    <deviceName>NOVEOS® Immunoassay System</deviceName>
    <manufacturerName>Hycor Biomedical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000031449</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020192</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63000</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:23:20.203Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870024448</udiDi>
    <basicUdiDi>081687002IN006-3UR</basicUdiDi>
    <tradeName>00816870024448</tradeName>
    <deviceName>Autoplex® G3 ELISA &amp; CLIA Analyzer</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IN006-3</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:23:18.562Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870020082</udiDi>
    <basicUdiDi>081687002IN006-2UP</basicUdiDi>
    <tradeName>00816870020082</tradeName>
    <deviceName>Autoplex® G2 ELISA &amp; CLIA Analyzer</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IN006-2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:22:55.148Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870020075</udiDi>
    <basicUdiDi>081687002IN006ZU</basicUdiDi>
    <tradeName>00816870020075</tradeName>
    <deviceName>Autoplex® ELISA &amp; CLIA Analyzer</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IN006</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:22:55.120Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870020068</udiDi>
    <basicUdiDi>081687002IN013ZR</basicUdiDi>
    <tradeName>00816870020068</tradeName>
    <deviceName>PrisMatic® ELISA Analyzer</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020201</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IN013</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:22:54.630Z</lastUpdated>
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  <row>
    <udiDi>00816870020051</udiDi>
    <basicUdiDi>081687002IN00925</basicUdiDi>
    <tradeName>00816870020051</tradeName>
    <deviceName>NeoEldex® ELISA Analyzer</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020201</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IN009</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:22:50.527Z</lastUpdated>
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    <udiDi>00816870020013</udiDi>
    <basicUdiDi>081687002IN00823</basicUdiDi>
    <tradeName>00816870020013</tradeName>
    <deviceName>LuMatic® CLIA Analyzer</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020201</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IN008</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:22:46.828Z</lastUpdated>
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    <udiDi>00816870020006</udiDi>
    <basicUdiDi>081687002IN010ZK</basicUdiDi>
    <tradeName>00816870020006</tradeName>
    <deviceName>NeoLumax® CLIA Analyzer</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020201</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IN010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:22:45.040Z</lastUpdated>
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    <udiDi>00816776020025</udiDi>
    <basicUdiDi>081677602MSTKPF0802BU</basicUdiDi>
    <tradeName>Acquity</tradeName>
    <deviceName>Waters IVD Systems</deviceName>
    <manufacturerName>Waters Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000025801</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201050201</emdnCode>
    <emdnDescription>HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>186015000IVD</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:22:13.126Z</lastUpdated>
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    <udiDi>00811403019984</udiDi>
    <basicUdiDi>0811403010DDPROLYTEQY</basicUdiDi>
    <tradeName>00811403019984</tradeName>
    <deviceName>ProLyte Electrolyte Analyzer</deviceName>
    <manufacturerName>Diamond Diagnostics Inc</manufacturerName>
    <manufacturerSrn>US-MF-000035435</manufacturerSrn>
    <authorisedRepresentativeName>Diamond Diagnostics Inc. Magyarországi Fióktelepe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034351</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201040201</emdnCode>
    <emdnDescription>ION SELECTIVE ELECTROLYTE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0-DD-PROLYTE</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:04:51.848Z</lastUpdated>
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    <udiDi>00811403010042</udiDi>
    <basicUdiDi>0811403010DDUNITYUB</basicUdiDi>
    <tradeName>ISE Analyzer</tradeName>
    <deviceName>Diamond Unity ISE Module</deviceName>
    <manufacturerName>Diamond Diagnostics Inc</manufacturerName>
    <manufacturerSrn>US-MF-000035435</manufacturerSrn>
    <authorisedRepresentativeName>Diamond Diagnostics Inc. Magyarországi Fióktelepe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034351</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201040201</emdnCode>
    <emdnDescription>ION SELECTIVE ELECTROLYTE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0-DD-Unity</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:59:38.278Z</lastUpdated>
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