<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06939716404977</udiDi>
    <basicUdiDi>697139043040886</basicUdiDi>
    <tradeName>HOKAPI™ HCG</tradeName>
    <deviceName>HOKAPI™ HCG</deviceName>
    <manufacturerName>Suzhou Hokapi Biomedical Engineering Co., Ltd..</manufacturerName>
    <manufacturerSrn>CN-MF-000013723</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050205</emdnCode>
    <emdnDescription>TOTAL HUMAN CHORIONIC GONADOTROPIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010408001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:54:55.012Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975577171900</udiDi>
    <basicUdiDi>697015090000047HA</basicUdiDi>
    <tradeName>AMH  CLIA Microparticles</tradeName>
    <deviceName>AMH CLIA Microparticles</deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMS0501</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:11:55.282Z</lastUpdated>
  </row>
  <row>
    <udiDi>06939716401808</udiDi>
    <basicUdiDi>693971640412LJ</basicUdiDi>
    <tradeName>HOKAPI™ AMH</tradeName>
    <deviceName>HOKAPI™ AMH</deviceName>
    <manufacturerName>Suzhou Hokapi Biomedical Engineering Co., Ltd..</manufacturerName>
    <manufacturerSrn>CN-MF-000013723</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010412401</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:23:35.783Z</lastUpdated>
  </row>
  <row>
    <udiDi>06926802605356</udiDi>
    <basicUdiDi>69268026MD761F0000000013C</basicUdiDi>
    <tradeName>06926802605356</tradeName>
    <deviceName>Total β- Human Chorionic Gonadotropin (CLIA)</deviceName>
    <manufacturerName>MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000005925</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050205</emdnCode>
    <emdnDescription>TOTAL HUMAN CHORIONIC GONADOTROPIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCL05801E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:41:16.197Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391523441193</udiDi>
    <basicUdiDi>539152344IMMA069L</basicUdiDi>
    <tradeName>Multichem AMH</tradeName>
    <deviceName>Multichem AMH</deviceName>
    <manufacturerName>Techno-path Manufacturing Ltd.</manufacturerName>
    <manufacturerSrn>IE-MF-000001822</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM500A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:14:36.140Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260743470737</udiDi>
    <basicUdiDi>426074347.2.13.1.704.5G</basicUdiDi>
    <tradeName>hey mela Schwangerschaftstest</tradeName>
    <deviceName>hey mela Schwangerschaftstest</deviceName>
    <manufacturerName>VELLAP Diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000035636</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050205</emdnCode>
    <emdnDescription>TOTAL HUMAN CHORIONIC GONADOTROPIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2.13.1.715</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:09:00.513Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049325030527</udiDi>
    <basicUdiDi>4049325IVR06080009BU7</basicUdiDi>
    <tradeName>Estriol high sensitive Saliva ELISA</tradeName>
    <deviceName>Estriol high sensitive Saliva ELISA</deviceName>
    <manufacturerName>IBL International GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000015709</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050202</emdnCode>
    <emdnDescription>ESTRIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30121046</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T16:04:25.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590787486</udiDi>
    <basicUdiDi>150995905D00324RC</basicUdiDi>
    <tradeName>AMH Gen II ELISA KIT</tradeName>
    <deviceName>AMH Gen II ELISA KIT</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D00324</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:00:36.673Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590740481</udiDi>
    <basicUdiDi>150995903AccAMHAdFB</basicUdiDi>
    <tradeName>Access AMH Advanced (Reagent Pack)</tradeName>
    <deviceName>Access AMH Advanced (Reagent Pack)</deviceName>
    <manufacturerName>IMMUNOTECH SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000011121</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C629997</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:50:26.247Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590669263</udiDi>
    <basicUdiDi>150995903AccAMHN5</basicUdiDi>
    <tradeName>Access AMH Reagent Pack</tradeName>
    <deviceName>Access AMH Reagent Pack</deviceName>
    <manufacturerName>IMMUNOTECH SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000011121</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B13127</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:49:55.831Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590744380</udiDi>
    <basicUdiDi>150995901A9000TBhCGLA</basicUdiDi>
    <tradeName>Access Total βhCG (Reagent Pack)</tradeName>
    <deviceName>Access Total βhCG (Reagent Pack)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050205</emdnCode>
    <emdnDescription>TOTAL HUMAN CHORIONIC GONADOTROPIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C28645</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:39:38.228Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590702120</udiDi>
    <basicUdiDi>150995901AccEstriol56</basicUdiDi>
    <tradeName>Access Unconjugated Estriol (Reagent Pack)</tradeName>
    <deviceName>Access Unconjugated Estriol (Reagent Pack)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050203</emdnCode>
    <emdnDescription>UNCONJUGATED (FREE) ESTRIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C22255</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:39:20.612Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971390439869</udiDi>
    <basicUdiDi>697139043040988</basicUdiDi>
    <tradeName>HOKAPI™ BETA-HCG</tradeName>
    <deviceName>HOKAPI™ BETA-HCG</deviceName>
    <manufacturerName>Suzhou Hokapi Biomedical Engineering Co., Ltd..</manufacturerName>
    <manufacturerSrn>CN-MF-000013723</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050206</emdnCode>
    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010409101</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:02:18.335Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971390439852</udiDi>
    <basicUdiDi>697139043040988</basicUdiDi>
    <tradeName>HOKAPI™ BETA-HCG</tradeName>
    <deviceName>HOKAPI™ BETA-HCG</deviceName>
    <manufacturerName>Suzhou Hokapi Biomedical Engineering Co., Ltd..</manufacturerName>
    <manufacturerSrn>CN-MF-000013723</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050206</emdnCode>
    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010409401</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:02:12.460Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970871280068</udiDi>
    <basicUdiDi>B-06970871280068</basicUdiDi>
    <tradeName>ONE STEP hCG PREGNANCY TEST</tradeName>
    <deviceName>ONE STEP hCG PREGNANCY TEST</deviceName>
    <manufacturerName>Qingdao AIBO Diagnostic Co., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000041127</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050206</emdnCode>
    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>midstream 12test</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:31:31.106Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970871280051</udiDi>
    <basicUdiDi>B-06970871280051</basicUdiDi>
    <tradeName>ONE STEP hCG PREGNANCY TEST</tradeName>
    <deviceName>ONE STEP hCG PREGNANCY TEST</deviceName>
    <manufacturerName>Qingdao AIBO Diagnostic Co., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000041127</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050206</emdnCode>
    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>midstream 1test</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:31:25.103Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970664751652</udiDi>
    <basicUdiDi>B-06970664751652</basicUdiDi>
    <tradeName>06970664751652</tradeName>
    <deviceName>Anti-Müllerian Hormone Rapid Test Kit (FIA)</deviceName>
    <manufacturerName>BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC</manufacturerName>
    <manufacturerSrn>CN-MF-000019125</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25Tests/Kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:33:14.552Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970522649589</udiDi>
    <basicUdiDi>B-06970522649589</basicUdiDi>
    <tradeName>Anti-Mullerian Hormone (AMH) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Anti-Mullerian Hormone (AMH) Assay 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>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL1402</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:48:42.151Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970522649558</udiDi>
    <basicUdiDi>B-06970522649558</basicUdiDi>
    <tradeName>Progesterone (Prog) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Progesterone (Prog) Assay 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>W0102050204</emdnCode>
    <emdnDescription>ESTRONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL1602</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:48:34.937Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970522649008</udiDi>
    <basicUdiDi>B-06970522649008</basicUdiDi>
    <tradeName>Inhibin-B(INHB) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Inhibin-B(INHB) Assay 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>W0102050214</emdnCode>
    <emdnDescription>INHIBIN A/B (PRENATAL SCREENING)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL2201</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:47:56.554Z</lastUpdated>
  </row>
</eudamedExport>