<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00810039380529</udiDi>
    <basicUdiDi>081003938LDX0009YG</basicUdiDi>
    <tradeName>LDX</tradeName>
    <deviceName>Cholestech LDX™ Analyzer</deviceName>
    <manufacturerName>Alere San Diego, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008348</manufacturerSrn>
    <authorisedRepresentativeName>Abbott Rapid Dx International Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000091</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>14-875</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:38:25.827Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978527670003</udiDi>
    <basicUdiDi>06978527BK-EL****NP</basicUdiDi>
    <tradeName>Elisa Microplate Reader</tradeName>
    <deviceName>Elisa Microplate Reader</deviceName>
    <manufacturerName>Biobase Biogrand Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030480</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020201</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BK-EL10A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:17:03.317Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974546543397</udiDi>
    <basicUdiDi>0697454654M0300YN</basicUdiDi>
    <tradeName>Aucheer iSort 300 Dry fluorescence immunoassay analyzer</tradeName>
    <deviceName>Aucheer iSort 300 Dry fluorescence immunoassay analyzer</deviceName>
    <manufacturerName>NINGBO AUCHEER BIOTECHNOLOGY CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000038081</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020201</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0300</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:15:35.987Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974546541232</udiDi>
    <basicUdiDi>0697454654L0300YB</basicUdiDi>
    <tradeName>Aucheer iRaTe 300 Dry fluorescence immunoassay analyzer</tradeName>
    <deviceName>Aucheer iRaTe 300 Dry fluorescence immunoassay analyzer</deviceName>
    <manufacturerName>NINGBO AUCHEER BIOTECHNOLOGY CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000038081</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020201</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L0300</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:15:13.513Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768012334</udiDi>
    <basicUdiDi>0405686902111UT</basicUdiDi>
    <tradeName>N Cuvette Segments for BN ProSpec</tradeName>
    <deviceName>IVDR_27_MAR EB_A_BN_PS_Cuv</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020285</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446539</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:38:03.570Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768012297</udiDi>
    <basicUdiDi>0405686902112UV</basicUdiDi>
    <tradeName>N Evaporation Caps for Control Vials (2.5 mL)</tradeName>
    <deviceName>IVDR_27_MAR EB_A_N_Eva_Caps</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020285</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446534</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:38:02.754Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768012174</udiDi>
    <basicUdiDi>0405686902110UR</basicUdiDi>
    <tradeName>N Predilution Wells</tradeName>
    <deviceName>IVDR_27_MAR EB_A_N_Predil_Well</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020285</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446521</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:37:57.134Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414006239</udiDi>
    <basicUdiDi>0405686900854W2</basicUdiDi>
    <tradeName>Atellica NEPH 630 System</tradeName>
    <deviceName>IVDR_27_MAR EB_A_INST_ANEPH630</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020204</emdnCode>
    <emdnDescription>NEPHELOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11239861</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:12:25.206Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414002903</udiDi>
    <basicUdiDi>0405686900856W6</basicUdiDi>
    <tradeName>BN II System</tradeName>
    <deviceName>IVDR_27_MAR EB_A_INST_BNII</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020204</emdnCode>
    <emdnDescription>NEPHELOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11254820</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:12:24.410Z</lastUpdated>
  </row>
  <row>
    <udiDi>00382904409104</udiDi>
    <basicUdiDi>038290JFFJQZFU8P</basicUdiDi>
    <tradeName>BD PhoenixSpec</tradeName>
    <deviceName>BD PhoenixSpec™ Nephelometer</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000018910</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020204</emdnCode>
    <emdnDescription>NEPHELOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>440910</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:34:01.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>111938738460</udiDi>
    <basicUdiDi>PP13707READER74</basicUdiDi>
    <tradeName>111938738460</tradeName>
    <deviceName>Ledetect96</deviceName>
    <manufacturerName>biomed Dr. Wieser GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000028269</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020201</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Many</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:43:56.119Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-iNSTAXPLORPF8</udiDi>
    <basicUdiDi>B-iNSTAXPLORPF8</basicUdiDi>
    <tradeName>iNSTA XPLOR® P</tradeName>
    <deviceName>iNSTA XPLOR P PA 001</deviceName>
    <manufacturerName>STRUmed Solutions Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023119</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201020204</emdnCode>
    <emdnDescription>NEPHELOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iNSTA XPLOR® P PA 001</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:19:48.957Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978274250411</udiDi>
    <basicUdiDi>6978274250000DG</basicUdiDi>
    <tradeName>Rapid Test Reader</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ACtest Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049724</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020201</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>aca-A02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:54:52.460Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810047983880</udiDi>
    <basicUdiDi>0810047980004BGG</basicUdiDi>
    <tradeName>Dry-type Fluorescent Immunoassay Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Acro Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017832</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020201</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AFR-ACO600</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:13:41.028Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768012303</udiDi>
    <basicUdiDi>0405686902112UV</basicUdiDi>
    <tradeName>N Evaporation Caps for Reagent Vials (5 ml)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020285</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446535</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:13:21.168Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810186842857</udiDi>
    <basicUdiDi>0810047980015AGN</basicUdiDi>
    <tradeName>Lateral Flow (LF) Portable Reader</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Acro Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017832</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020201</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACA101</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:13:08.504Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977338230482</udiDi>
    <basicUdiDi>697733823000HDS</basicUdiDi>
    <tradeName>06977338230482</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newlink Biotech co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045176</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020201</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L21-LR300</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:13:08.214Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810164510280</udiDi>
    <basicUdiDi>0810164510000MZ</basicUdiDi>
    <tradeName>Fluorescence Immunoasasy Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aceso Laboratories, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045175</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020201</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EQB01-FI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:13:04.087Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810164510297</udiDi>
    <basicUdiDi>0810164510000MZ</basicUdiDi>
    <tradeName>Fluorescence Immunoasasy Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aceso Laboratories, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045175</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020201</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EQD01-FI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:12:52.485Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810164511218</udiDi>
    <basicUdiDi>0810164510000MZ</basicUdiDi>
    <tradeName>Fluorescence Immunoasasy Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aceso Laboratories, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045175</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020201</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EQE01-FI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:12:42.274Z</lastUpdated>
  </row>
</eudamedExport>