<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-RR2EG</udiDi>
    <basicUdiDi>B-RR2EG</basicUdiDi>
    <tradeName>Crypto/Giardia CEL Reagent</tradeName>
    <deviceName>Crypto/Giardia CEL Reagent</deviceName>
    <manufacturerName>Cellabs Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000030640</manufacturerSrn>
    <authorisedRepresentativeName>WMDE B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002062</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050308</emdnCode>
    <emdnDescription>GIARDIA LAMBLIA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RR2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:28:38.552Z</lastUpdated>
  </row>
  <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-JW20102NW-50TE5</udiDi>
    <basicUdiDi>B-JW20102NW-50TE5</basicUdiDi>
    <tradeName>Plasmodium DNA Real Time PCR Kit</tradeName>
    <deviceName>Plasmodium DNA Real Time PCR Kit</deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JW20102NW-50T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:35:30.669Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-JW20102NW-25TE5</udiDi>
    <basicUdiDi>B-JW20102NW-25TE5</basicUdiDi>
    <tradeName>Plasmodium DNA Real Time PCR Kit</tradeName>
    <deviceName>Plasmodium DNA Real Time PCR Kit</deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JW20102NW-25T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:35:29.874Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-JB60110NW-50TR6</udiDi>
    <basicUdiDi>B-JB60110NW-50TR6</basicUdiDi>
    <tradeName>Trichomonas Vaginalis Real Time PCR Kit</tradeName>
    <deviceName>Trichomonas Vaginalis Real Time PCR Kit</deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050211</emdnCode>
    <emdnDescription>TRICHOMONAS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JB60110NW-50T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:22:47.171Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-JB60110NW-25TR6</udiDi>
    <basicUdiDi>B-JB60110NW-25TR6</basicUdiDi>
    <tradeName>Trichomonas Vaginalis Real Time PCR Kit</tradeName>
    <deviceName>Trichomonas Vaginalis Real Time PCR Kit</deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050211</emdnCode>
    <emdnDescription>TRICHOMONAS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JB60110NW-25T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:22:46.356Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ILEI-R4027J</udiDi>
    <basicUdiDi>B-ILEI-R4027J</basicUdiDi>
    <tradeName>Leishmania IgG/IgM Rapid Test Cassette</tradeName>
    <deviceName>Leishmania IgG/IgM Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050205</emdnCode>
    <emdnDescription>LEISHMANIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILEI-R402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:12:14.211Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IGL-R602DN</udiDi>
    <basicUdiDi>B-IGL-R602DN</basicUdiDi>
    <tradeName>Giardia Lamblia Rapid Test Cassette</tradeName>
    <deviceName>Giardia Lamblia Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050208</emdnCode>
    <emdnDescription>GIARDIA LAMBLIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IGL-R602</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:09:27.589Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IEH-R602AY</udiDi>
    <basicUdiDi>B-IEH-R602AY</basicUdiDi>
    <tradeName>Entamoeba histolytica Rapid Test Cassette</tradeName>
    <deviceName>Entamoeba histolytica Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050201</emdnCode>
    <emdnDescription>ENTAMOEBA HISTOLYTICA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IEH-R602</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:05:41.812Z</lastUpdated>
  </row>
</eudamedExport>