<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05411967002542</udiDi>
    <basicUdiDi>5411967SPMGS135</basicUdiDi>
    <tradeName>SpermMar Test IgG antiserum</tradeName>
    <deviceName>SpermMar Test IgG Single kit</deviceName>
    <manufacturerName>FertiPro</manufacturerName>
    <manufacturerSrn>BE-MF-000000313</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102109013</emdnCode>
    <emdnDescription>SPERM ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SPMG_A</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:59:56.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>05411967002566</udiDi>
    <basicUdiDi>5411967SPMAS127</basicUdiDi>
    <tradeName>SpermMar Test IgA Single kit</tradeName>
    <deviceName>SpermMar Test IgA Single kit</deviceName>
    <manufacturerName>FertiPro</manufacturerName>
    <manufacturerSrn>BE-MF-000000313</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102109013</emdnCode>
    <emdnDescription>SPERM ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SPMA_S</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:52:04.737Z</lastUpdated>
  </row>
  <row>
    <udiDi>05411967001354</udiDi>
    <basicUdiDi>5411967SPMGC1ZJ</basicUdiDi>
    <tradeName>SpermMar Test IgG Complete kit</tradeName>
    <deviceName>SpermMar Test IgG Complete kit</deviceName>
    <manufacturerName>FertiPro</manufacturerName>
    <manufacturerSrn>BE-MF-000000313</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102109013</emdnCode>
    <emdnDescription>SPERM ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SPMG_C</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:51:56.735Z</lastUpdated>
  </row>
  <row>
    <udiDi>05411967001347</udiDi>
    <basicUdiDi>5411967SPMAC1YL</basicUdiDi>
    <tradeName>SpermMar Test IgA Complete kit</tradeName>
    <deviceName>SpermMar Test IgA Complete kit</deviceName>
    <manufacturerName>FertiPro</manufacturerName>
    <manufacturerSrn>BE-MF-000000313</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102109013</emdnCode>
    <emdnDescription>SPERM ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SPMA_C</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:51:56.059Z</lastUpdated>
  </row>
  <row>
    <udiDi>05411967000036</udiDi>
    <basicUdiDi>5411967SPMGS135</basicUdiDi>
    <tradeName>SpermMar Test IgG Single kit</tradeName>
    <deviceName>SpermMar Test IgG Single kit</deviceName>
    <manufacturerName>FertiPro</manufacturerName>
    <manufacturerSrn>BE-MF-000000313</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102109013</emdnCode>
    <emdnDescription>SPERM ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SPMG_S</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:51:37.909Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A5093</udiDi>
    <basicUdiDi>B-A5093</basicUdiDi>
    <tradeName>D-A5093</tradeName>
    <deviceName>INDICAID™ Antisperm Antibody Test</deviceName>
    <manufacturerName>Phase Scientific International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000025791</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102109013</emdnCode>
    <emdnDescription>SPERM ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INDICAID™ Antisperm Antibody Test</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:43:47.783Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-693757990302PS</udiDi>
    <basicUdiDi>B-693757990302PS</basicUdiDi>
    <tradeName>Fast Diagnostic Screening Test for Sperm Concentration</tradeName>
    <deviceName>Fast Diagnostic Screening Test for Sperm Concentration</deviceName>
    <manufacturerName>Nantong EgensBiotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021561</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102109013</emdnCode>
    <emdnDescription>SPERM ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JZMD cassette</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:48:41.104Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-107FE</udiDi>
    <basicUdiDi>B-6-107FE</basicUdiDi>
    <tradeName>D-6-107FE</tradeName>
    <deviceName>Anti-Spermatozoa IgG Assay Kit (Chemiluminescent Microparticle Immunoassay)</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102109013</emdnCode>
    <emdnDescription>SPERM ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: USIA00000183M, USIA00000184M"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:07:53.818Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-108FG</udiDi>
    <basicUdiDi>B-6-108FG</basicUdiDi>
    <tradeName>D-6-108FG</tradeName>
    <deviceName>Anti-Spermatozoa IgM Assay Kit(Chemiluminescent Microparticle Immunoassay)</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102109013</emdnCode>
    <emdnDescription>SPERM ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: USIA00000181M, USIA00000182M"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:07:52.218Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GASPE-902a6U</udiDi>
    <basicUdiDi>B-GASPE-902a6U</basicUdiDi>
    <tradeName>Male Fertility Rapid Test Cassette (Semen)</tradeName>
    <deviceName>Male Fertility Rapid Test Cassette (Semen)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102109013</emdnCode>
    <emdnDescription>SPERM ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GASPE-902a</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:14:51.953Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049325012288</udiDi>
    <basicUdiDi>B-04049325012288</basicUdiDi>
    <tradeName>anti-Sperm Ab ELISA</tradeName>
    <deviceName>anti-Sperm Ab ELISA</deviceName>
    <manufacturerName>IBL International GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000015709</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102109013</emdnCode>
    <emdnDescription>SPERM ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE52001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:11:20.696Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049325001640</udiDi>
    <basicUdiDi>B-04049325001640</basicUdiDi>
    <tradeName>Spermatozoa-Ab ELISA</tradeName>
    <deviceName>Spermatozoa-Ab ELISA</deviceName>
    <manufacturerName>IBL International GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000015709</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102109013</emdnCode>
    <emdnDescription>SPERM ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE52029</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:08:02.036Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970522640913</udiDi>
    <basicUdiDi>B-06970522640913</basicUdiDi>
    <tradeName>Anti-sperm antibody IgM (ASA-IgM) Dectection Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Anti-sperm antibody IgM (ASA-IgM) Dectection Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102109013</emdnCode>
    <emdnDescription>SPERM ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DB0501</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:45:33.613Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970522640791</udiDi>
    <basicUdiDi>B-06970522640791</basicUdiDi>
    <tradeName>Anti-sperm antibody IgG (ASA-IgG) Dectection Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Anti-sperm antibody IgG (ASA-IgG) Dectection Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102109013</emdnCode>
    <emdnDescription>SPERM ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DB0401</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:45:32.411Z</lastUpdated>
  </row>
  <row>
    <udiDi>05411967002559</udiDi>
    <basicUdiDi>5411967SPMGS135</basicUdiDi>
    <tradeName>SpermMar Test IgG Latex bead solution</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FertiPro</manufacturerName>
    <manufacturerSrn>BE-MF-000000313</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102109013</emdnCode>
    <emdnDescription>SPERM ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SPMG_L</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-24T20:51:29.752Z</lastUpdated>
  </row>
</eudamedExport>