<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-R146142P</udiDi>
    <basicUdiDi>B-R146142P</basicUdiDi>
    <tradeName>D-R146142P</tradeName>
    <deviceName>Hypersensitive C-Reactive Protein (hs-CRP) 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>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R14614</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:02:09.902Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R146132M</udiDi>
    <basicUdiDi>B-R146132M</basicUdiDi>
    <tradeName>D-R146132M</tradeName>
    <deviceName>Hypersensitive C-Reactive Protein (hs-CRP) 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>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R14613</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:02:09.095Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R146122K</udiDi>
    <basicUdiDi>B-R146122K</basicUdiDi>
    <tradeName>D-R146122K</tradeName>
    <deviceName>Hypersensitive C-Reactive Protein (hs-CRP) 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>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R14612</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:02:08.284Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R146112H</udiDi>
    <basicUdiDi>B-R146112H</basicUdiDi>
    <tradeName>D-R146112H</tradeName>
    <deviceName>Hypersensitive C-Reactive Protein (hs-CRP) 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>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R14611</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:02:04.279Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R145142J</udiDi>
    <basicUdiDi>B-R145142J</basicUdiDi>
    <tradeName>D-R145142J</tradeName>
    <deviceName>Serum Amyloid A Protein (SAA) 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>W0103030399</emdnCode>
    <emdnDescription>ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R14514</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:02:03.476Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R145132G</udiDi>
    <basicUdiDi>B-R145132G</basicUdiDi>
    <tradeName>D-R145132G</tradeName>
    <deviceName>Serum Amyloid A Protein (SAA) 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>W0103030399</emdnCode>
    <emdnDescription>ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R14513</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:02:02.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R145122E</udiDi>
    <basicUdiDi>B-R145122E</basicUdiDi>
    <tradeName>D-R145122E</tradeName>
    <deviceName>Serum Amyloid A Protein (SAA) 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>W0103030399</emdnCode>
    <emdnDescription>ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R14512</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:02:01.986Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R144132B</udiDi>
    <basicUdiDi>B-R144132B</basicUdiDi>
    <tradeName>D-R144132B</tradeName>
    <deviceName>Interleukin 6 (IL-6) 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>W01030609</emdnCode>
    <emdnDescription>INTERLEUKIN 6 (IL-6)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R14413</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:01:57.875Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R1441229</udiDi>
    <basicUdiDi>B-R1441229</basicUdiDi>
    <tradeName>D-R1441229</tradeName>
    <deviceName>Interleukin 6 (IL-6) 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>W01030609</emdnCode>
    <emdnDescription>INTERLEUKIN 6 (IL-6)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R14412</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:01:57.077Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R145112C</udiDi>
    <basicUdiDi>B-R145112C</basicUdiDi>
    <tradeName>D-R145112C</tradeName>
    <deviceName>Serum Amyloid A Protein (SAA) 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>W0103030399</emdnCode>
    <emdnDescription>ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R14511</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:01:56.272Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R144142D</udiDi>
    <basicUdiDi>B-R144142D</basicUdiDi>
    <tradeName>D-R144142D</tradeName>
    <deviceName>Interleukin 6 (IL-6) 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>W01030609</emdnCode>
    <emdnDescription>INTERLEUKIN 6 (IL-6)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R14414</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:01:55.606Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R1441127</udiDi>
    <basicUdiDi>B-R1441127</basicUdiDi>
    <tradeName>D-R1441127</tradeName>
    <deviceName>Interleukin 6 (IL-6) 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>W01030609</emdnCode>
    <emdnDescription>INTERLEUKIN 6 (IL-6)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R14411</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:01:38.613Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R1431428</udiDi>
    <basicUdiDi>B-R1431428</basicUdiDi>
    <tradeName>D-R1431428</tradeName>
    <deviceName>Procalcitonin (PCT) 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>W0102069013</emdnCode>
    <emdnDescription>PROCALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R14314</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:01:38.304Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R1431326</udiDi>
    <basicUdiDi>B-R1431326</basicUdiDi>
    <tradeName>D-R1431326</tradeName>
    <deviceName>Procalcitonin (PCT) 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>W0102069013</emdnCode>
    <emdnDescription>PROCALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R14313</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:01:37.028Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R1431224</udiDi>
    <basicUdiDi>B-R1431224</basicUdiDi>
    <tradeName>D-R1431224</tradeName>
    <deviceName>Procalcitonin (PCT) 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>W0102069013</emdnCode>
    <emdnDescription>PROCALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R14312</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:01:36.217Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R1431122</udiDi>
    <basicUdiDi>B-R1431122</basicUdiDi>
    <tradeName>D-R1431122</tradeName>
    <deviceName>Procalcitonin (PCT) 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>W0102069013</emdnCode>
    <emdnDescription>PROCALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R14311</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:01:32.210Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R1421423</udiDi>
    <basicUdiDi>B-R1421423</basicUdiDi>
    <tradeName>D-R1421423</tradeName>
    <deviceName>Anti-Mullerian Hormone (AMH) 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>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R14214</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:01:31.457Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R14213ZW</udiDi>
    <basicUdiDi>B-R14213ZW</basicUdiDi>
    <tradeName>D-R14213ZW</tradeName>
    <deviceName>Anti-Mullerian Hormone (AMH) 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>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R14213</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:01:30.855Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R14212ZU</udiDi>
    <basicUdiDi>B-R14212ZU</basicUdiDi>
    <tradeName>D-R14212ZU</tradeName>
    <deviceName>Anti-Mullerian Hormone (AMH) 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>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R14212</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:01:29.901Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R14211ZS</udiDi>
    <basicUdiDi>B-R14211ZS</basicUdiDi>
    <tradeName>D-R14211ZS</tradeName>
    <deviceName>Anti-Mullerian Hormone (AMH) 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>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R14211</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:01:25.822Z</lastUpdated>
  </row>
</eudamedExport>