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    <tradeName>iFlash-Anti-TP</tradeName>
    <deviceName>iFlash-Anti-TP</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <reference>C88049-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:30:08.286Z</lastUpdated>
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    <udiDi>08431673231330</udiDi>
    <basicUdiDi>B-08431673231330</basicUdiDi>
    <tradeName>RPR-CARBON</tradeName>
    <deviceName>Rapid plasma reagin</deviceName>
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    <udiDi>08431673204082</udiDi>
    <basicUdiDi>B-08431673204082</basicUdiDi>
    <tradeName>TPHA</tradeName>
    <deviceName>Treponema pallidum haemagglutination</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
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    <udiDi>08431673204068</udiDi>
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    <tradeName>VDRL</tradeName>
    <deviceName>Venereal disease research laboratory</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>1200406</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-27T21:44:33.295Z</lastUpdated>
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    <udiDi>08431673204051</udiDi>
    <basicUdiDi>B-08431673204051</basicUdiDi>
    <tradeName>VDRL</tradeName>
    <deviceName>Venereal disease research laboratory</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010306</emdnCode>
    <emdnDescription>SYPHILIS, REAGIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1200405</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-27T21:44:32.499Z</lastUpdated>
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    <udiDi>08431673204020</udiDi>
    <basicUdiDi>B-08431673204020</basicUdiDi>
    <tradeName>RPR-CARBON</tradeName>
    <deviceName>Rapid plasma reagin</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>SYPHILIS, REAGIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1200402</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-27T21:44:31.701Z</lastUpdated>
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    <udiDi>08431673204013</udiDi>
    <basicUdiDi>B-08431673204013</basicUdiDi>
    <tradeName>RPR-CARBON</tradeName>
    <deviceName>Rapid plasma reagin</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W0105010306</emdnCode>
    <emdnDescription>SYPHILIS, REAGIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1200401</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-27T21:44:30.900Z</lastUpdated>
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    <udiDi>08431673001889</udiDi>
    <basicUdiDi>B-08431673001889</basicUdiDi>
    <tradeName>RPR-CARBON</tradeName>
    <deviceName>Rapid plasma reagin</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <emdnDescription>SYPHILIS, REAGIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40131</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-27T21:41:22.514Z</lastUpdated>
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    <udiDi>08431673001872</udiDi>
    <basicUdiDi>B-08431673001872</basicUdiDi>
    <tradeName>RPR-CARBON</tradeName>
    <deviceName>Rapid plasma reagin</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W0105010306</emdnCode>
    <emdnDescription>SYPHILIS, REAGIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40130</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-27T21:41:21.700Z</lastUpdated>
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    <udiDi>D-FI-SYP-4026D</udiDi>
    <basicUdiDi>B-FI-SYP-4026D</basicUdiDi>
    <tradeName>Syphilis Test Cassette</tradeName>
    <deviceName>Syphilis Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FI-SYP-402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-24T22:43:56.009Z</lastUpdated>
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    <udiDi>D-Z093686X</udiDi>
    <basicUdiDi>B-Z093686X</basicUdiDi>
    <tradeName>D-Z093686X</tradeName>
    <deviceName>Anti-Syphilis Ab</deviceName>
    <manufacturerName>DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.</manufacturerName>
    <manufacturerSrn>AT-MF-000000254</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z09368</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-24T19:51:58.379Z</lastUpdated>
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    <udiDi>D-Z043665Q</udiDi>
    <basicUdiDi>B-Z043665Q</basicUdiDi>
    <tradeName>D-Z043665Q</tradeName>
    <deviceName>Anti-Syphilis Ab</deviceName>
    <manufacturerName>DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.</manufacturerName>
    <manufacturerSrn>AT-MF-000000254</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z04366</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-24T19:51:53.582Z</lastUpdated>
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    <udiDi>D-R179163X</udiDi>
    <basicUdiDi>B-R179163X</basicUdiDi>
    <tradeName>D-R179163X</tradeName>
    <deviceName>Treponema Pallidum Antibody (Anti-TP) 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>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R17916</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:06:20.770Z</lastUpdated>
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    <udiDi>D-R179153V</udiDi>
    <basicUdiDi>B-R179153V</basicUdiDi>
    <tradeName>D-R179153V</tradeName>
    <deviceName>Treponema Pallidum Antibody (Anti-TP) 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>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R17915</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:06:16.314Z</lastUpdated>
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    <udiDi>D-R179143T</udiDi>
    <basicUdiDi>B-R179143T</basicUdiDi>
    <tradeName>D-R179143T</tradeName>
    <deviceName>Treponema Pallidum Antibody (Anti-TP) 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>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>R17914</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:06:15.072Z</lastUpdated>
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    <udiDi>D-R179133R</udiDi>
    <basicUdiDi>B-R179133R</basicUdiDi>
    <tradeName>D-R179133R</tradeName>
    <deviceName>Treponema Pallidum Antibody (Anti-TP) 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>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>R17913</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:06:14.504Z</lastUpdated>
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    <udiDi>D-R179123P</udiDi>
    <basicUdiDi>B-R179123P</basicUdiDi>
    <tradeName>D-R179123P</tradeName>
    <deviceName>Treponema Pallidum Antibody (Anti-TP) 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>
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    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R17912</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:06:13.480Z</lastUpdated>
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    <deviceName>Treponema Pallidum Antibody (Anti-TP) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>R17911</reference>
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    <lastUpdated>2026-07-22T12:06:09.463Z</lastUpdated>
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    <tradeName>Syphilis Rapid Test Cassette</tradeName>
    <deviceName>Syphilis 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>
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    <emdnCode>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
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    <reference>ISY-R402</reference>
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    <lastUpdated>2026-07-17T02:04:31.738Z</lastUpdated>
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    <basicUdiDi>B-84352873210027</basicUdiDi>
    <tradeName>Cromatest</tradeName>
    <deviceName>TPHA</deviceName>
    <manufacturerName>Linear Chemicals S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000003284</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2520015</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:32:55.703Z</lastUpdated>
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