<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-R136142G</udiDi>
    <basicUdiDi>B-R136142G</basicUdiDi>
    <tradeName>D-R136142G</tradeName>
    <deviceName>Follicle Stimulating Hormone (FSH) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050104</emdnCode>
    <emdnDescription>FOLLICLE STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R13614</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:59:23.728Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R136132E</udiDi>
    <basicUdiDi>B-R136132E</basicUdiDi>
    <tradeName>D-R136132E</tradeName>
    <deviceName>Follicle Stimulating Hormone (FSH) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050104</emdnCode>
    <emdnDescription>FOLLICLE STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R13613</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:59:21.283Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R136122C</udiDi>
    <basicUdiDi>B-R136122C</basicUdiDi>
    <tradeName>D-R136122C</tradeName>
    <deviceName>Follicle Stimulating Hormone (FSH) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050104</emdnCode>
    <emdnDescription>FOLLICLE STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R13612</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:59:20.470Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R136112A</udiDi>
    <basicUdiDi>B-R136112A</basicUdiDi>
    <tradeName>D-R136112A</tradeName>
    <deviceName>Follicle Stimulating Hormone (FSH) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050104</emdnCode>
    <emdnDescription>FOLLICLE STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R13611</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:59:19.682Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R135142B</udiDi>
    <basicUdiDi>B-R135142B</basicUdiDi>
    <tradeName>D-R135142B</tradeName>
    <deviceName>Luteinizing Hormone (LH) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050105</emdnCode>
    <emdnDescription>LUTEINISING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R13514</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:59:18.896Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R1351329</udiDi>
    <basicUdiDi>B-R1351329</basicUdiDi>
    <tradeName>D-R1351329</tradeName>
    <deviceName>Luteinizing Hormone (LH) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050105</emdnCode>
    <emdnDescription>LUTEINISING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R13513</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:59:14.876Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R1351227</udiDi>
    <basicUdiDi>B-R1351227</basicUdiDi>
    <tradeName>D-R1351227</tradeName>
    <deviceName>Luteinizing Hormone (LH) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050105</emdnCode>
    <emdnDescription>LUTEINISING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R13512</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:59:14.073Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R1351125</udiDi>
    <basicUdiDi>B-R1351125</basicUdiDi>
    <tradeName>D-R1351125</tradeName>
    <deviceName>Luteinizing Hormone (LH) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050105</emdnCode>
    <emdnDescription>LUTEINISING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R13511</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:59:13.271Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R1331523</udiDi>
    <basicUdiDi>B-R1331523</basicUdiDi>
    <tradeName>D-R1331523</tradeName>
    <deviceName>Anti-Thyroglobulin Antibodies (Anti-TG) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100303</emdnCode>
    <emdnDescription>THYROGLOBULIN AUTOANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R13315</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:59:12.473Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R13314ZW</udiDi>
    <basicUdiDi>B-R13314ZW</basicUdiDi>
    <tradeName>D-R13314ZW</tradeName>
    <deviceName>Anti-Thyroglobulin Antibodies (Anti-TG) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100303</emdnCode>
    <emdnDescription>THYROGLOBULIN AUTOANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R13314</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:59:08.469Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R13313ZU</udiDi>
    <basicUdiDi>B-R13313ZU</basicUdiDi>
    <tradeName>D-R13313ZU</tradeName>
    <deviceName>Anti-Thyroglobulin Antibodies (Anti-TG) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100303</emdnCode>
    <emdnDescription>THYROGLOBULIN AUTOANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R13313</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:59:07.803Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R13311ZQ</udiDi>
    <basicUdiDi>B-R13311ZQ</basicUdiDi>
    <tradeName>D-R13311ZQ</tradeName>
    <deviceName>Anti-Thyroglobulin Antibodies (Anti-TG) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100303</emdnCode>
    <emdnDescription>THYROGLOBULIN AUTOANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R13311</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:59:06.873Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R13214ZR</udiDi>
    <basicUdiDi>B-R13214ZR</basicUdiDi>
    <tradeName>D-R13214ZR</tradeName>
    <deviceName>Total Thyroxine (TT4) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020407</emdnCode>
    <emdnDescription>THYROXINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R13214</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:59:06.112Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R13213ZP</udiDi>
    <basicUdiDi>B-R13213ZP</basicUdiDi>
    <tradeName>D-R13213ZP</tradeName>
    <deviceName>Total Thyroxine (TT4) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020407</emdnCode>
    <emdnDescription>THYROXINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R13213</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:59:02.069Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R13212ZM</udiDi>
    <basicUdiDi>B-R13212ZM</basicUdiDi>
    <tradeName>D-R13212ZM</tradeName>
    <deviceName>Total Thyroxine (TT4) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020407</emdnCode>
    <emdnDescription>THYROXINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R13212</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:59:01.407Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R13211ZK</udiDi>
    <basicUdiDi>B-R13211ZK</basicUdiDi>
    <tradeName>D-R13211ZK</tradeName>
    <deviceName>Total Thyroxine (TT4) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020407</emdnCode>
    <emdnDescription>THYROXINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R13211</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:58:46.003Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R13114ZL</udiDi>
    <basicUdiDi>B-R13114ZL</basicUdiDi>
    <tradeName>D-R13114ZL</tradeName>
    <deviceName>Free Thyroxine (FT4) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020402</emdnCode>
    <emdnDescription>FREE THYROXINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R13114</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:58:45.212Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R13113ZJ</udiDi>
    <basicUdiDi>B-R13113ZJ</basicUdiDi>
    <tradeName>D-R13113ZJ</tradeName>
    <deviceName>Free Thyroxine (FT4) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020402</emdnCode>
    <emdnDescription>FREE THYROXINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R13113</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:58:44.405Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R13112ZG</udiDi>
    <basicUdiDi>B-R13112ZG</basicUdiDi>
    <tradeName>D-R13112ZG</tradeName>
    <deviceName>Free Thyroxine (FT4) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020402</emdnCode>
    <emdnDescription>FREE THYROXINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R13112</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:58:43.860Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R13111ZE</udiDi>
    <basicUdiDi>B-R13111ZE</basicUdiDi>
    <tradeName>D-R13111ZE</tradeName>
    <deviceName>Free Thyroxine (FT4) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020402</emdnCode>
    <emdnDescription>FREE THYROXINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R13111</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:58:39.597Z</lastUpdated>
  </row>
</eudamedExport>