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<eudamedExport entity="devices">
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    <udiDi>06920234700221</udiDi>
    <basicUdiDi>69202347BRED002CL</basicUdiDi>
    <tradeName>Kit for determination of the DNA fragmentation level in spermatozoa (SCD method)</tradeName>
    <deviceName>Kit for determination of the DNA fragmentation level in spermatozoa (SCD method)</deviceName>
    <manufacturerName>BRED Life Science Technology Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000037518</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010302</emdnCode>
    <emdnDescription>ROMANOWSKY STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10 tests/kit</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:16:53.419Z</lastUpdated>
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  <row>
    <udiDi>06430074451714</udiDi>
    <basicUdiDi>6430074451002118W</basicUdiDi>
    <tradeName>May-Grünwald solution</tradeName>
    <deviceName>May-Grünwald solution</deviceName>
    <manufacturerName>Reagena Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000002804</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010302</emdnCode>
    <emdnDescription>ROMANOWSKY STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>180211</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T05:59:07.162Z</lastUpdated>
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  <row>
    <udiDi>06430074451103</udiDi>
    <basicUdiDi>64300744510011999</basicUdiDi>
    <tradeName>Giemsa solution</tradeName>
    <deviceName>Giemsa solution</deviceName>
    <manufacturerName>Reagena Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000002804</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010302</emdnCode>
    <emdnDescription>ROMANOWSKY STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>180119</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T05:59:05.568Z</lastUpdated>
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  <row>
    <udiDi>14719874742895</udiDi>
    <basicUdiDi>471987474R11PT</basicUdiDi>
    <tradeName>LensHooke® Sperm Double Strand DNA Fragmentation Rapid Test Kit (SDFR assay)</tradeName>
    <deviceName>LensHooke® Sperm Double Strand DNA Fragmentation Rapid Test Kit (SDFR assay)</deviceName>
    <manufacturerName>Bonraybio Co., LTD.</manufacturerName>
    <manufacturerSrn>TW-MF-000029512</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010302</emdnCode>
    <emdnDescription>ROMANOWSKY STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R11 Plus</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:20:36.742Z</lastUpdated>
  </row>
  <row>
    <udiDi>14719874742512</udiDi>
    <basicUdiDi>471987474CR0QE</basicUdiDi>
    <tradeName>LensHooke® Prestained Morphology Slide</tradeName>
    <deviceName>LensHooke® Prestained Morphology Slide</deviceName>
    <manufacturerName>Bonraybio Co., LTD.</manufacturerName>
    <manufacturerSrn>TW-MF-000029512</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010302</emdnCode>
    <emdnDescription>ROMANOWSKY STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR0</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:20:35.143Z</lastUpdated>
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  <row>
    <udiDi>04022536111841</udiDi>
    <basicUdiDi>4061841109204SF</basicUdiDi>
    <tradeName>Giemsa’s azur eosin methylene blue solution for microscopy</tradeName>
    <deviceName>Giemsa's azur eosin methylene blue solution for microscopy</deviceName>
    <manufacturerName>Merck KGaA</manufacturerName>
    <manufacturerSrn>DE-MF-000018777</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010302</emdnCode>
    <emdnDescription>ROMANOWSKY STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1092040100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T17:40:23.889Z</lastUpdated>
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  <row>
    <udiDi>03858888822026</udiDi>
    <basicUdiDi>385889212HPC3010302HMCA</basicUdiDi>
    <tradeName>Bio-Diff komplet, 3x500 mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioGnost Ltd.</manufacturerName>
    <manufacturerSrn>HR-MF-000022153</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010302</emdnCode>
    <emdnDescription>ROMANOWSKY STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BD-K-500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:04:20.254Z</lastUpdated>
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  <row>
    <udiDi>03858888822033</udiDi>
    <basicUdiDi>385889212HPC3010302HMCA</basicUdiDi>
    <tradeName>Bio-Diff komplet, 3x1000 mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioGnost Ltd.</manufacturerName>
    <manufacturerSrn>HR-MF-000022153</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010302</emdnCode>
    <emdnDescription>ROMANOWSKY STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BD-K-1L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:04:20.243Z</lastUpdated>
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  <row>
    <udiDi>03858888822095</udiDi>
    <basicUdiDi>385889212HPC3010302HMCA</basicUdiDi>
    <tradeName>Giemsa otopina, 100 mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioGnost Ltd.</manufacturerName>
    <manufacturerSrn>HR-MF-000022153</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010302</emdnCode>
    <emdnDescription>ROMANOWSKY STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GM-OT-100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:04:20.146Z</lastUpdated>
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  <row>
    <udiDi>03858888822101</udiDi>
    <basicUdiDi>385889212HPC3010302HMCA</basicUdiDi>
    <tradeName>Giemsa otopina, 500 mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioGnost Ltd.</manufacturerName>
    <manufacturerSrn>HR-MF-000022153</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010302</emdnCode>
    <emdnDescription>ROMANOWSKY STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GM-OT-500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:04:20.136Z</lastUpdated>
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  <row>
    <udiDi>03858888822118</udiDi>
    <basicUdiDi>385889212HPC3010302HMCA</basicUdiDi>
    <tradeName>Giemsa otopina, 1000 mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioGnost Ltd.</manufacturerName>
    <manufacturerSrn>HR-MF-000022153</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010302</emdnCode>
    <emdnDescription>ROMANOWSKY STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GM-OT-1L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:04:20.122Z</lastUpdated>
  </row>
  <row>
    <udiDi>03858888822125</udiDi>
    <basicUdiDi>385889212HPC3010302HMCA</basicUdiDi>
    <tradeName>Hayemova otopina, 100 mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioGnost Ltd.</manufacturerName>
    <manufacturerSrn>HR-MF-000022153</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010302</emdnCode>
    <emdnDescription>ROMANOWSKY STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HY-OT-100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:04:20.105Z</lastUpdated>
  </row>
  <row>
    <udiDi>03858888822132</udiDi>
    <basicUdiDi>385889212HPC3010302HMCA</basicUdiDi>
    <tradeName>Hayemova otopina, 500 mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioGnost Ltd.</manufacturerName>
    <manufacturerSrn>HR-MF-000022153</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010302</emdnCode>
    <emdnDescription>ROMANOWSKY STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HY-OT-500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:04:20.089Z</lastUpdated>
  </row>
  <row>
    <udiDi>03858888822262</udiDi>
    <basicUdiDi>385889212HPC3010302HMCA</basicUdiDi>
    <tradeName>Leishman otopina, 100 mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioGnost Ltd.</manufacturerName>
    <manufacturerSrn>HR-MF-000022153</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010302</emdnCode>
    <emdnDescription>ROMANOWSKY STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LE-OT-100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:04:19.951Z</lastUpdated>
  </row>
  <row>
    <udiDi>03858888822279</udiDi>
    <basicUdiDi>385889212HPC3010302HMCA</basicUdiDi>
    <tradeName>Leishman otopina, 500 mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioGnost Ltd.</manufacturerName>
    <manufacturerSrn>HR-MF-000022153</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010302</emdnCode>
    <emdnDescription>ROMANOWSKY STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LE-OT-500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:04:19.938Z</lastUpdated>
  </row>
  <row>
    <udiDi>03858888822286</udiDi>
    <basicUdiDi>385889212HPC3010302HMCA</basicUdiDi>
    <tradeName>Leishman otopina, 1000 mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioGnost Ltd.</manufacturerName>
    <manufacturerSrn>HR-MF-000022153</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010302</emdnCode>
    <emdnDescription>ROMANOWSKY STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LE-OT-1L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:04:19.921Z</lastUpdated>
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  <row>
    <udiDi>03858888822316</udiDi>
    <basicUdiDi>385889212HPC3010302HMCA</basicUdiDi>
    <tradeName>May-Gruenwald otopina, 100 mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioGnost Ltd.</manufacturerName>
    <manufacturerSrn>HR-MF-000022153</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010302</emdnCode>
    <emdnDescription>ROMANOWSKY STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MG-OT-100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:04:19.888Z</lastUpdated>
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  <row>
    <udiDi>03858888822323</udiDi>
    <basicUdiDi>385889212HPC3010302HMCA</basicUdiDi>
    <tradeName>May-Gruenwald otopina, 500 mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioGnost Ltd.</manufacturerName>
    <manufacturerSrn>HR-MF-000022153</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010302</emdnCode>
    <emdnDescription>ROMANOWSKY STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MG-OT-500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:04:19.876Z</lastUpdated>
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    <udiDi>03858888822330</udiDi>
    <basicUdiDi>385889212HPC3010302HMCA</basicUdiDi>
    <tradeName>May-Gruenwald otopina, 1000 mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioGnost Ltd.</manufacturerName>
    <manufacturerSrn>HR-MF-000022153</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010302</emdnCode>
    <emdnDescription>ROMANOWSKY STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MG-OT-1L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:04:19.858Z</lastUpdated>
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  <row>
    <udiDi>03858888822392</udiDi>
    <basicUdiDi>385889212HPC3010302HMCA</basicUdiDi>
    <tradeName>Tuerkova otopina, 100 mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioGnost Ltd.</manufacturerName>
    <manufacturerSrn>HR-MF-000022153</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010302</emdnCode>
    <emdnDescription>ROMANOWSKY STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TU-OT-100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:04:19.815Z</lastUpdated>
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