<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04605979401566</udiDi>
    <basicUdiDi>B-04605979401566</basicUdiDi>
    <tradeName>DS-EIA-GONADOTROPIN-FSH</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RPC Diagnostic Systems Ltd.</manufacturerName>
    <manufacturerSrn>RU-MF-000043555</manufacturerSrn>
    <authorisedRepresentativeName>AB Diagnostic Systems GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000025750</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102050104</emdnCode>
    <emdnDescription>FOLLICLE STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>RH-151/1.1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:47:24.964Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971390434895</udiDi>
    <basicUdiDi>69713904304017Q</basicUdiDi>
    <tradeName>HOKAPI™ FSH</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0102050104</emdnCode>
    <emdnDescription>FOLLICLE STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010401401</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:49:50.291Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971390434901</udiDi>
    <basicUdiDi>69713904304017Q</basicUdiDi>
    <tradeName>HOKAPI™ FSH</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0102050104</emdnCode>
    <emdnDescription>FOLLICLE STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010401101</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:49:50.270Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973864380028</udiDi>
    <basicUdiDi>6978364380004FA</basicUdiDi>
    <tradeName>06973864380028</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chemclin Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009729</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050104</emdnCode>
    <emdnDescription>FOLLICLE STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05010301372</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:13:29.691Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973864380035</udiDi>
    <basicUdiDi>6978364380004FA</basicUdiDi>
    <tradeName>06973864380035</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chemclin Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009729</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050104</emdnCode>
    <emdnDescription>FOLLICLE STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05010301332</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:13:29.673Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973864380042</udiDi>
    <basicUdiDi>6978364380004FA</basicUdiDi>
    <tradeName>06973864380042</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chemclin Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009729</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050104</emdnCode>
    <emdnDescription>FOLLICLE STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05010301342</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:13:29.656Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975577177568</udiDi>
    <basicUdiDi>697015090000027H4</basicUdiDi>
    <tradeName>AutoLumo FSH Calibrators</tradeName>
    <deviceName></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>W0102050104</emdnCode>
    <emdnDescription>FOLLICLE STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA080501</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:27:56.671Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976485025408</udiDi>
    <basicUdiDi>697648502FSHVN</basicUdiDi>
    <tradeName>Pylon FSH</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ET Healthcare (Suzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000039448</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050104</emdnCode>
    <emdnDescription>FOLLICLE STIMULATING HORMONE</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>20-2217	100 tests/kit</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:06:32.745Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976485025415</udiDi>
    <basicUdiDi>697648502FSHVN</basicUdiDi>
    <tradeName>Pylon FSH</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ET Healthcare (Suzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000039448</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050104</emdnCode>
    <emdnDescription>FOLLICLE STIMULATING HORMONE</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>30-2217	200 tests/kit</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:06:32.717Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465235029</udiDi>
    <basicUdiDi>697846523HormoneB08J5</basicUdiDi>
    <tradeName>Follicle Stimulating Hormone Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050104</emdnCode>
    <emdnDescription>FOLLICLE STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2×50 test</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:38:52.940Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465237757</udiDi>
    <basicUdiDi>697846523HormoneB08J5</basicUdiDi>
    <tradeName>Follicle Stimulating Hormone Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050104</emdnCode>
    <emdnDescription>FOLLICLE STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:38:49.731Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465237764</udiDi>
    <basicUdiDi>697846523HormoneB08J5</basicUdiDi>
    <tradeName>Follicle Stimulating Hormone Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050104</emdnCode>
    <emdnDescription>FOLLICLE STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 tests</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:38:49.714Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465237771</udiDi>
    <basicUdiDi>697846523HormoneB08J5</basicUdiDi>
    <tradeName>Follicle Stimulating Hormone Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050104</emdnCode>
    <emdnDescription>FOLLICLE STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:38:49.693Z</lastUpdated>
  </row>
</eudamedExport>