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<eudamedExport entity="devices">
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    <udiDi>08806128310562</udiDi>
    <basicUdiDi>88061283AGM2100MDV</basicUdiDi>
    <tradeName>GlucoDr.™ Blood Glucose Test Meter</tradeName>
    <deviceName>AGM-2100 Blood Glucose Test Meter</deviceName>
    <manufacturerName>All Medicus Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020833</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AGM-2100-M1-P1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:59:31.142Z</lastUpdated>
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  <row>
    <udiDi>08800065166008</udiDi>
    <basicUdiDi>88000651HAAHM000C8</basicUdiDi>
    <tradeName>CERA-STAT™ 4000 Analyzer</tradeName>
    <deviceName>CERA-STAT™ 4000 Analyzer</deviceName>
    <manufacturerName>GC MEDIS Corp.</manufacturerName>
    <manufacturerSrn>KR-MF-000012638</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS400M10</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:58:47.115Z</lastUpdated>
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    <udiDi>08800038500426</udiDi>
    <basicUdiDi>88000385CZFFNAL8</basicUdiDi>
    <tradeName>HURO PATH® Filter (FNA)</tradeName>
    <deviceName>HURO PATH® Filter (FNA)</deviceName>
    <manufacturerName>CelltraZone Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000026492</manufacturerSrn>
    <authorisedRepresentativeName>Javitech Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000045915</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02069085</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AFFNA001</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:58:38.236Z</lastUpdated>
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    <udiDi>08800038500419</udiDi>
    <basicUdiDi>88000385CZFSTDNZ</basicUdiDi>
    <tradeName>HURO PATH® Filter</tradeName>
    <deviceName>HURO PATH® Filter</deviceName>
    <manufacturerName>CelltraZone Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000026492</manufacturerSrn>
    <authorisedRepresentativeName>Javitech Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000045915</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02069085</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AFSTD001</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:58:37.443Z</lastUpdated>
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  <row>
    <udiDi>08800038500341</udiDi>
    <basicUdiDi>88000385CZEPREPSM</basicUdiDi>
    <tradeName>E-Prep Plus</tradeName>
    <deviceName>Sample processing instruments</deviceName>
    <manufacturerName>CelltraZone Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000026492</manufacturerSrn>
    <authorisedRepresentativeName>Javitech Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000045915</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02069099</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>ALBCCZ002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:58:32.638Z</lastUpdated>
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  <row>
    <udiDi>08800038500327</udiDi>
    <basicUdiDi>88000385CZHUROTVX</basicUdiDi>
    <tradeName>HURO PATH® T</tradeName>
    <deviceName>Sample processing instruments</deviceName>
    <manufacturerName>CelltraZone Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000026492</manufacturerSrn>
    <authorisedRepresentativeName>Javitech Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000045915</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02069099</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ALBCCZ003</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:58:31.840Z</lastUpdated>
  </row>
  <row>
    <udiDi>08719189137811</udiDi>
    <basicUdiDi>8719189137FRNK5AQW</basicUdiDi>
    <tradeName>Starrsed ILXS 220-240 Vac</tradeName>
    <deviceName>Starrsed ILXS</deviceName>
    <manufacturerName>RR Mechatronics Manufacturing BV</manufacturerName>
    <manufacturerSrn>NL-MF-000023105</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029001</emdnCode>
    <emdnDescription>ERYTHROCYTE SEDIMENTATION RATE DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A0032301</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:52:29.805Z</lastUpdated>
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  <row>
    <udiDi>08719189137798</udiDi>
    <basicUdiDi>8719189137HDA8BCGH</basicUdiDi>
    <tradeName>Starrsed NSTA 230V/240V</tradeName>
    <deviceName>Starrsed NSTA</deviceName>
    <manufacturerName>RR Mechatronics Manufacturing BV</manufacturerName>
    <manufacturerSrn>NL-MF-000023105</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029001</emdnCode>
    <emdnDescription>ERYTHROCYTE SEDIMENTATION RATE DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A0030113</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:52:12.938Z</lastUpdated>
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  <row>
    <udiDi>08719189137484</udiDi>
    <basicUdiDi>8719189137XH61THP4</basicUdiDi>
    <tradeName>RPI-ECO21 230V</tradeName>
    <deviceName>RPI</deviceName>
    <manufacturerName>RR Mechatronics Manufacturing BV</manufacturerName>
    <manufacturerSrn>NL-MF-000023105</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02079002</emdnCode>
    <emdnDescription>DILUTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A0021595</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:52:06.515Z</lastUpdated>
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    <udiDi>08719189137330</udiDi>
    <basicUdiDi>8719189137A385ZC87</basicUdiDi>
    <tradeName>Starrsed TL 230V</tradeName>
    <deviceName>Starrsed TL</deviceName>
    <manufacturerName>RR Mechatronics Manufacturing BV</manufacturerName>
    <manufacturerSrn>NL-MF-000023105</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029001</emdnCode>
    <emdnDescription>ERYTHROCYTE SEDIMENTATION RATE DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TLAX109100</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:52:04.115Z</lastUpdated>
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  <row>
    <udiDi>08719189137088</udiDi>
    <basicUdiDi>8719189137PH257CGN</basicUdiDi>
    <tradeName>Interrliner XN1 FRL 230V</tradeName>
    <deviceName>Interrliner</deviceName>
    <manufacturerName>RR Mechatronics Manufacturing BV</manufacturerName>
    <manufacturerSrn>NL-MF-000023105</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029001</emdnCode>
    <emdnDescription>ERYTHROCYTE SEDIMENTATION RATE DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EHST109621</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:51:51.312Z</lastUpdated>
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    <udiDi>08719189137033</udiDi>
    <basicUdiDi>8719189137YLN25BSV</basicUdiDi>
    <tradeName>Starrsed RS 230V Sysmex Low profile with inserts</tradeName>
    <deviceName>Starrsed RS</deviceName>
    <manufacturerName>RR Mechatronics Manufacturing BV</manufacturerName>
    <manufacturerSrn>NL-MF-000023105</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029001</emdnCode>
    <emdnDescription>ERYTHROCYTE SEDIMENTATION RATE DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VERA109900</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:51:49.714Z</lastUpdated>
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    <udiDi>08718469360642</udiDi>
    <basicUdiDi>871846936ngsengineX5</basicUdiDi>
    <tradeName>NGSengine®</tradeName>
    <deviceName>NGSengine</deviceName>
    <manufacturerName>Genome Diagnostics B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000453</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050192</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4949940, 4949740, 4949840, 4949640</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:44:32.748Z</lastUpdated>
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    <udiDi>08684595032268</udiDi>
    <basicUdiDi>868459503MH57</basicUdiDi>
    <tradeName>Micro Heater Incubator</tradeName>
    <deviceName>Mini Immunofluorescence Analyzer</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>VMH1001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:28:54.365Z</lastUpdated>
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    <udiDi>08684595032251</udiDi>
    <basicUdiDi>868459503FIAProMiniR3</basicUdiDi>
    <tradeName>FIAPro™ Mini Immunofluorescence Analyzer</tradeName>
    <deviceName>Mini Immunofluorescence Analyzer</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>VMFIA1006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:28:52.763Z</lastUpdated>
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    <udiDi>08681820382075</udiDi>
    <basicUdiDi>868182038CYTSQ</basicUdiDi>
    <tradeName>Single Cytology Funnel with White Filter</tradeName>
    <deviceName>Cytology Funnel</deviceName>
    <manufacturerName>Biyosistem Medikal Limited Sirketi</manufacturerName>
    <manufacturerSrn>TR-MF-000037366</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02069004</emdnCode>
    <emdnDescription>CYTOCENTRIFUGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HCT-SNG-0W50</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:22:52.984Z</lastUpdated>
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    <udiDi>08681820380651</udiDi>
    <basicUdiDi>868182038BLDQC</basicUdiDi>
    <tradeName>Microtome Blade, Specimen, Cut-S35</tradeName>
    <deviceName>Microtome Blade</deviceName>
    <manufacturerName>Biyosistem Medikal Limited Sirketi</manufacturerName>
    <manufacturerSrn>TR-MF-000037366</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202059085</emdnCode>
    <emdnDescription>VARIOUS PROCESSING INSTRUMENTS FOR HYSTOLOGY / CYTOLOGY - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HMC-S35-0050</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:22:44.156Z</lastUpdated>
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    <udiDi>08595696305772</udiDi>
    <basicUdiDi>859569630077R4</basicUdiDi>
    <tradeName>croGENE Real-Time PCR System</tradeName>
    <deviceName>croGENE Real-Time PCR System</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050199</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CGRT6/96</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:17:37.062Z</lastUpdated>
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    <udiDi>08594211580014</udiDi>
    <basicUdiDi>859421158LCGQC</basicUdiDi>
    <tradeName>LUCIA Cytogenetics, version 4.2</tradeName>
    <deviceName>LUCIA Cytogenetics</deviceName>
    <manufacturerName>Laboratory Imaging s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000025008</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202050392</emdnCode>
    <emdnDescription>LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:17:23.237Z</lastUpdated>
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    <udiDi>04260563550350</udiDi>
    <basicUdiDi>4260563550237VS</basicUdiDi>
    <tradeName>MH Guide</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Molecular Health GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000012861</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050192</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1000000141</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:55:18.469Z</lastUpdated>
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