<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-R038122B</udiDi>
    <basicUdiDi>B-R038122B</basicUdiDi>
    <tradeName>D-R038122B</tradeName>
    <deviceName>Total Protein Assay Reagent Kit (Biuret Method)</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>W01010230</emdnCode>
    <emdnDescription>TOTAL PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R03812</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-21T04:32:04.794Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R0371226</udiDi>
    <basicUdiDi>B-R0371226</basicUdiDi>
    <tradeName>D-R0371226</tradeName>
    <deviceName>Albumin Assay Reagent Kit (BCG Method)</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>W01010201</emdnCode>
    <emdnDescription>ALBUMIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R03712</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-21T04:32:04.014Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R03512ZR</udiDi>
    <basicUdiDi>B-R03512ZR</basicUdiDi>
    <tradeName>D-R03512ZR</tradeName>
    <deviceName>High Density Lipoprotein Cholesterol Assay Reagent Kit (Direct-Select Inhibitory Method)</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>W01010215</emdnCode>
    <emdnDescription>HIGH DENSITY LIPOPROTEIN CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R03512</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-21T04:32:01.606Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R03112Z5</udiDi>
    <basicUdiDi>B-R03112Z5</basicUdiDi>
    <tradeName>D-R03112Z5</tradeName>
    <deviceName>Uric Acid Assay Reagent Kit (Uricase Method)</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>W01010232</emdnCode>
    <emdnDescription>URIC ACID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R03112</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-21T04:32:00.798Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R0291229</udiDi>
    <basicUdiDi>B-R0291229</basicUdiDi>
    <tradeName>D-R0291229</tradeName>
    <deviceName>Urea Assay Reagent Kit (Urease-GLDH Method)</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>W0101060106</emdnCode>
    <emdnDescription>UREA TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R02912</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-21T04:31:59.991Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R02412ZD</udiDi>
    <basicUdiDi>B-R02412ZD</basicUdiDi>
    <tradeName>D-R02412ZD</tradeName>
    <deviceName>Glucose Assay Reagent Kit (Glucose Oxidase Method)</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>W01010213</emdnCode>
    <emdnDescription>GLUCOSE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R02412</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-21T04:31:59.199Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R02212Z3</udiDi>
    <basicUdiDi>B-R02212Z3</basicUdiDi>
    <tradeName>D-R02212Z3</tradeName>
    <deviceName>Lactate Dehydrogenase Assay Reagent Kit (Lactate Substrate Method)</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>W01010121</emdnCode>
    <emdnDescription>LACTATE DEHYDROGENASE ISOENZYMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R02212</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-21T04:31:55.192Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R02112YW</udiDi>
    <basicUdiDi>B-R02112YW</basicUdiDi>
    <tradeName>D-R02112YW</tradeName>
    <deviceName>Alkaline Phosphatase Assay Reagent Kit (NPP-AMP Buffer Method)</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>W01010106</emdnCode>
    <emdnDescription>ALKALINE PHOSPHATASE ISOENZYMES (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R02112</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-21T04:31:54.396Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R01712ZM</udiDi>
    <basicUdiDi>B-R01712ZM</basicUdiDi>
    <tradeName>D-R01712ZM</tradeName>
    <deviceName>Aspartate Aminotransferase Assay Reagent Kit (Aspartate Method)</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>W01010110</emdnCode>
    <emdnDescription>ASPARTATE AMINO-TRANSFERASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R01712</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-21T04:31:53.604Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R01512ZB</udiDi>
    <basicUdiDi>B-R01512ZB</basicUdiDi>
    <tradeName>D-R01512ZB</tradeName>
    <deviceName>Alanine Aminotransferase Assay Reagent Kit (Alanine Method)</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>W01010103</emdnCode>
    <emdnDescription>ALANINE AMINO-TRANSFERASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R01512</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-21T04:31:52.789Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R1341528</udiDi>
    <basicUdiDi>B-R1341528</basicUdiDi>
    <tradeName>D-R1341528</tradeName>
    <deviceName>Antibody to Thyroid Peroxidase (Anti-TPO) 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>W0102100301</emdnCode>
    <emdnDescription>THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R13415</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-20T03:35:54.794Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R0281224</udiDi>
    <basicUdiDi>B-R0281224</basicUdiDi>
    <tradeName>D-R0281224</tradeName>
    <deviceName>Triglycerides Assay Reagent Kit (GPO-PAP Method)</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>W01010231</emdnCode>
    <emdnDescription>TRIGLYCERIDES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R02812</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-20T03:35:53.200Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RT-7600SV</udiDi>
    <basicUdiDi>B-RT-7600SV</basicUdiDi>
    <tradeName>D-RT-7600SV</tradeName>
    <deviceName>Auto Hematology Analyzer</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>W0202010201</emdnCode>
    <emdnDescription>AUTOMATED 3 PART HEMATOLOGY ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RT-7600</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:32:43.944Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R2231527</udiDi>
    <basicUdiDi>B-R2231527</basicUdiDi>
    <tradeName>D-R2231527</tradeName>
    <deviceName>Soluble Growth Stimulation Expression Gene 2 Protein (ST2) 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>W0102060404</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR II</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R22315</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:25:38.445Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R2231323</udiDi>
    <basicUdiDi>B-R2231323</basicUdiDi>
    <tradeName>D-R2231323</tradeName>
    <deviceName>Soluble Growth Stimulation Expression Gene 2 Protein (ST2) 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>W0102060404</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR II</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R22313</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:25:34.423Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R2231425</udiDi>
    <basicUdiDi>B-R2231425</basicUdiDi>
    <tradeName>D-R2231425</tradeName>
    <deviceName>Soluble Growth Stimulation Expression Gene 2 Protein (ST2) 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>W0102060404</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR II</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R22314</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:25:33.623Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R22312ZW</udiDi>
    <basicUdiDi>B-R22312ZW</basicUdiDi>
    <tradeName>D-R22312ZW</tradeName>
    <deviceName>Soluble Growth Stimulation Expression Gene 2 Protein (ST2) 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>W0102060404</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR II</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R22312</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:25:32.826Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R22311ZU</udiDi>
    <basicUdiDi>B-R22311ZU</basicUdiDi>
    <tradeName>D-R22311ZU</tradeName>
    <deviceName>Soluble Growth Stimulation Expression Gene 2 Protein (ST2) 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>W0102060404</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR II</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R22311</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:25:32.022Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R22214ZV</udiDi>
    <basicUdiDi>B-R22214ZV</basicUdiDi>
    <tradeName>D-R22214ZV</tradeName>
    <deviceName>High-Sensitivity Cardiac Troponin T (hs-cTnT) 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>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R22214</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:25:26.416Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R22213ZT</udiDi>
    <basicUdiDi>B-R22213ZT</basicUdiDi>
    <tradeName>D-R22213ZT</tradeName>
    <deviceName>High-Sensitivity Cardiac Troponin T (hs-cTnT) 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>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R22213</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:25:25.627Z</lastUpdated>
  </row>
</eudamedExport>