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    <tradeName>Toxo IgG CLIA Microparticles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050102</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMK0603</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:51:23.286Z</lastUpdated>
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    <udiDi>06903053021098</udiDi>
    <basicUdiDi>69449040004W-ToxoIgG***JT</basicUdiDi>
    <tradeName>Toxoplasma gondii IgG (CLIA)</tradeName>
    <deviceName>Toxoplasma gondii IgG (CLIA)</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050102</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-012525-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:47:54.434Z</lastUpdated>
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    <udiDi>03573026064440</udiDi>
    <basicUdiDi>357302BUDI000074T7</basicUdiDi>
    <tradeName>VIDAS® TOXO IgG II</tradeName>
    <deviceName>VIDAS® TOXO IgG II</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050102</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30210</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:48:01.093Z</lastUpdated>
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    <udiDi>08056771100939</udiDi>
    <basicUdiDi>80567713107804R</basicUdiDi>
    <tradeName>LIAISON® Toxo IgG II</tradeName>
    <deviceName>LIAISON® Toxo IgG II</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050102</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>310780</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-22T22:39:18.631Z</lastUpdated>
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    <udiDi>08054320950011</udiDi>
    <basicUdiDi>805432095ISID5001LN</basicUdiDi>
    <tradeName>08054320950011</tradeName>
    <deviceName>IDS TOXO IgG</deviceName>
    <manufacturerName>Technogenetics S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000025331</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050102</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-ID5001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:42:56.277Z</lastUpdated>
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    <udiDi>D-EIM4411116FN</udiDi>
    <basicUdiDi>B-EIM4411116FN</basicUdiDi>
    <tradeName>D-EIM4411116FN</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>EIM4411116</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:00:36.634Z</lastUpdated>
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    <udiDi>+ENTITOXG0460DS0K</udiDi>
    <basicUdiDi>B-+ENTITOXG0460DS0K</basicUdiDi>
    <tradeName>+ENTITOXG0460DS0K</tradeName>
    <deviceName>NovaLisa® Toxoplasma gondii IgG</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050102</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TOXG0460DS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:20:05.448Z</lastUpdated>
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    <udiDi>+ENTITOXG04600M</udiDi>
    <basicUdiDi>B-+ENTITOXG04600M</basicUdiDi>
    <tradeName>+ENTITOXG04600M</tradeName>
    <deviceName>NovaLisa® Toxoplasma gondii IgG</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050102</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TOXG0460</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:20:03.845Z</lastUpdated>
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    <udiDi>+ENTIRE5710108</udiDi>
    <basicUdiDi>B-+ENTIRE5710108</basicUdiDi>
    <tradeName>+ENTIRE5710108</tradeName>
    <deviceName>Toxoplasma gondii IgG</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050102</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE57101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:18:41.309Z</lastUpdated>
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    <udiDi>+ENTIEIA-386308</udiDi>
    <basicUdiDi>B-+ENTIEIA-386308</basicUdiDi>
    <tradeName>+ENTIEIA-386308</tradeName>
    <deviceName>Toxoplasma gondii IgG ELISA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050102</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIA-3863</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:13:09.194Z</lastUpdated>
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  <row>
    <udiDi>00630414962238</udiDi>
    <basicUdiDi>0405686901466VU</basicUdiDi>
    <tradeName>IMMULITE 2000 Toxoplasma Quantitative IgG</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_C_KIT_Toxoplasma Quantitative IgG</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050102</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10381323</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:26:36.215Z</lastUpdated>
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    <udiDi>00630414208459</udiDi>
    <basicUdiDi>0405686900810VE</basicUdiDi>
    <tradeName>ADVIA Centaur Toxoplasma G</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_KIT_Toxo G</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050102</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10310321</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:12:55.058Z</lastUpdated>
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  <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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