<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-R188143V</udiDi>
    <basicUdiDi>B-R188143V</basicUdiDi>
    <tradeName>D-R188143V</tradeName>
    <deviceName>Toxoplasma Gondii Antibody IgG (Toxo IgG) 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 Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050102</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY IGG</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>R18814</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:24:21.664Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R188133T</udiDi>
    <basicUdiDi>B-R188133T</basicUdiDi>
    <tradeName>D-R188133T</tradeName>
    <deviceName>Toxoplasma Gondii Antibody IgG (Toxo IgG) 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 Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050102</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY IGG</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>R18813</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:24:20.858Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R188163Z</udiDi>
    <basicUdiDi>B-R188163Z</basicUdiDi>
    <tradeName>D-R188163Z</tradeName>
    <deviceName>Toxoplasma Gondii Antibody IgG (Toxo IgG) 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 Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050102</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY IGG</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>R18816</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:24:20.059Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R188153X</udiDi>
    <basicUdiDi>B-R188153X</basicUdiDi>
    <tradeName>D-R188153X</tradeName>
    <deviceName>Toxoplasma Gondii Antibody IgG (Toxo IgG) 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 Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050102</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY IGG</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>R18815</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:24:19.651Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R188123R</udiDi>
    <basicUdiDi>B-R188123R</basicUdiDi>
    <tradeName>D-R188123R</tradeName>
    <deviceName>Toxoplasma Gondii Antibody IgG (Toxo IgG) 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 Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050102</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY IGG</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>R18812</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:24:02.407Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R188113P</udiDi>
    <basicUdiDi>B-R188113P</basicUdiDi>
    <tradeName>D-R188113P</tradeName>
    <deviceName>Toxoplasma Gondii Antibody IgG (Toxo IgG) 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 Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050102</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY IGG</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>R18811</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:24:01.638Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R184163D</udiDi>
    <basicUdiDi>B-R184163D</basicUdiDi>
    <tradeName>D-R184163D</tradeName>
    <deviceName>Toxoplasma Gondii Antibody IgM (Toxo IgM) 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 Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050103</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY IGM</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>R18416</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:23:41.587Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R184153B</udiDi>
    <basicUdiDi>B-R184153B</basicUdiDi>
    <tradeName>D-R184153B</tradeName>
    <deviceName>Toxoplasma Gondii Antibody IgM (Toxo IgM) 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 Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050103</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY IGM</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>R18415</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:23:40.787Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R1841439</udiDi>
    <basicUdiDi>B-R1841439</basicUdiDi>
    <tradeName>D-R1841439</tradeName>
    <deviceName>Toxoplasma Gondii Antibody IgM (Toxo IgM) 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 Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050103</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY IGM</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>R18414</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:23:36.781Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R1841337</udiDi>
    <basicUdiDi>B-R1841337</basicUdiDi>
    <tradeName>D-R1841337</tradeName>
    <deviceName>Toxoplasma Gondii Antibody IgM (Toxo IgM) 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 Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050103</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY IGM</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>R18413</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:23:35.984Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R1841235</udiDi>
    <basicUdiDi>B-R1841235</basicUdiDi>
    <tradeName>D-R1841235</tradeName>
    <deviceName>Toxoplasma Gondii Antibody IgM (Toxo IgM) 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 Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050103</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY IGM</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>R18412</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:23:35.655Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R1841133</udiDi>
    <basicUdiDi>B-R1841133</basicUdiDi>
    <tradeName>D-R1841133</tradeName>
    <deviceName>Toxoplasma Gondii Antibody IgM (Toxo IgM) 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 Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050103</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY IGM</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>R18411</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:23:35.290Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GKPD140XA</udiDi>
    <basicUdiDi>B-GKPD140XA</basicUdiDi>
    <tradeName>Toxoplasma gondii IgG/IgM Ab Rapid Test Kit</tradeName>
    <deviceName>Toxoplasma gondii IgG/IgM Ab Rapid Test Kit</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050101</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD140</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:38:18.294Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCTOX(IgM)-302aBR</udiDi>
    <basicUdiDi>B-GCTOX(IgM)-302aBR</basicUdiDi>
    <tradeName>Toxoplasma gondii (Toxo) IgM Rapid Test</tradeName>
    <deviceName>Toxoplasma gondii (Toxo) IgM Rapid Test</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050103</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCTOX(IgM)-302a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:32:39.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCTOX(IgG/IgM)-302a4G</udiDi>
    <basicUdiDi>B-GCTOX(IgG/IgM)-302a4G</basicUdiDi>
    <tradeName>Toxoplasma gondii (Toxo) IgG/IgM Rapid Test</tradeName>
    <deviceName>Toxoplasma gondii (Toxo) IgG/IgM Rapid Test</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050101</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCTOX(IgG/IgM)-302a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:32:38.698Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCTOX(IgG)-302a8K</udiDi>
    <basicUdiDi>B-GCTOX(IgG)-302a8K</basicUdiDi>
    <tradeName>Toxoplasma gondii (Toxo) IgG Rapid Test</tradeName>
    <deviceName>Toxoplasma gondii (Toxo) IgG Rapid Test</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050102</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCTOX(IgG)-302a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:32:34.705Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4415117GL</udiDi>
    <basicUdiDi>B-EIM4415117GL</basicUdiDi>
    <tradeName>D-EIM4415117GL</tradeName>
    <deviceName>Chemiluminescent Immunoassay Assay Kits for TOXO IgM</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050103</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4415117</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:58:36.046Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4415116GJ</udiDi>
    <basicUdiDi>B-EIM4415116GJ</basicUdiDi>
    <tradeName>D-EIM4415116GJ</tradeName>
    <deviceName>Chemiluminescent Immunoassay Assay Kits for TOXO IgG</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050102</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4415116</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:58:35.231Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4411117FQ</udiDi>
    <basicUdiDi>B-EIM4411117FQ</basicUdiDi>
    <tradeName>D-EIM4411117FQ</tradeName>
    <deviceName>Chemiluminescent Immunoassay Assay Kits for TOXO IgM</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050103</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4411117</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:58:32.075Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A31588UG</udiDi>
    <basicUdiDi>B-A31588UG</basicUdiDi>
    <tradeName>Access Toxo IgG</tradeName>
    <deviceName>Access Toxo IgG</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050102</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A31588</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:15:53.810Z</lastUpdated>
  </row>
</eudamedExport>