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    <basicUdiDi>76401582195002Q</basicUdiDi>
    <tradeName>Leishmania infantum IgG ELISA</tradeName>
    <deviceName>Leishmania infantum IgG ELISA</deviceName>
    <manufacturerName>Bordier Affinity Products SA</manufacturerName>
    <manufacturerSrn>CH-MF-000025247</manufacturerSrn>
    <authorisedRepresentativeName>Leman Diagnostics SARL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000024185</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050205</emdnCode>
    <emdnDescription>LEISHMANIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9500</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:28:14.568Z</lastUpdated>
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    <udiDi>D-ILEI-402EK</udiDi>
    <basicUdiDi>B-ILEI-402EK</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>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050205</emdnCode>
    <emdnDescription>LEISHMANIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILEI-402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:41:33.817Z</lastUpdated>
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    <udiDi>69743840310320</udiDi>
    <basicUdiDi>B-69743840310320</basicUdiDi>
    <tradeName>Leishmania IgG IgM Rapid Test</tradeName>
    <deviceName>Leishmania IgG IgM Rapid Test</deviceName>
    <manufacturerName>Zhejiang Anji Saianfu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045029</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050205</emdnCode>
    <emdnDescription>LEISHMANIA</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
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    <tradeName>+ENTIRE586410I</tradeName>
    <deviceName>Leishmania infantum IgG</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W0105050205</emdnCode>
    <emdnDescription>LEISHMANIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE58641</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:19:06.940Z</lastUpdated>
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    <udiDi>+ENTILEIG0310DS0O</udiDi>
    <basicUdiDi>B-+ENTILEIG0310DS0O</basicUdiDi>
    <tradeName>+ENTILEIG0310DS0O</tradeName>
    <deviceName>NovaLisa® Leishmania infantum IgG</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050205</emdnCode>
    <emdnDescription>LEISHMANIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LEIG0310DS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:15:31.125Z</lastUpdated>
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    <udiDi>+ENTILEIG03100Q</udiDi>
    <basicUdiDi>B-+ENTILEIG03100Q</basicUdiDi>
    <tradeName>+ENTILEIG03100Q</tradeName>
    <deviceName>NovaLisa® Leishmania infantum IgG</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050205</emdnCode>
    <emdnDescription>LEISHMANIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LEIG0310</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:15:15.080Z</lastUpdated>
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    <udiDi>+ENTIEIA-384306</udiDi>
    <basicUdiDi>B-+ENTIEIA-384306</basicUdiDi>
    <tradeName>+ENTIEIA-384306</tradeName>
    <deviceName>Leishmania infantum IgG ELISA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050205</emdnCode>
    <emdnDescription>LEISHMANIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIA-3843</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:12:56.402Z</lastUpdated>
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    <udiDi>+ENTIDEIG03100I</udiDi>
    <basicUdiDi>B-+ENTIDEIG03100I</basicUdiDi>
    <tradeName>+ENTIDEIG03100I</tradeName>
    <deviceName>Leishmania infantum IgG ELISA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050205</emdnCode>
    <emdnDescription>LEISHMANIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DEIG0310</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:11:08.195Z</lastUpdated>
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    <udiDi>D-YJB30123NW-50TXU</udiDi>
    <basicUdiDi>B-YJB30123NW-50TXU</basicUdiDi>
    <tradeName>Leishmania Real Time PCR Kit</tradeName>
    <deviceName>Leishmania 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>W0105050205</emdnCode>
    <emdnDescription>LEISHMANIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YJB30123NW-50T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:03:00.906Z</lastUpdated>
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    <udiDi>D-YJB30123NW-25TXU</udiDi>
    <basicUdiDi>B-YJB30123NW-25TXU</basicUdiDi>
    <tradeName>Leishmania Real Time PCR Kit</tradeName>
    <deviceName>Leishmania 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>W0105050205</emdnCode>
    <emdnDescription>LEISHMANIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YJB30123NW-25T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:03:00.114Z</lastUpdated>
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  <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>
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    <udiDi>D-GCKal-T402aYL</udiDi>
    <basicUdiDi>B-GCKal-T402aYL</basicUdiDi>
    <tradeName>Leishmania IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Leishmania IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050205</emdnCode>
    <emdnDescription>LEISHMANIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCKal-T402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:28:51.530Z</lastUpdated>
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    <udiDi>D-GCKal-T402aHGQK</udiDi>
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    <tradeName>Leishmania IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Leishmania IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050205</emdnCode>
    <emdnDescription>LEISHMANIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCKal-T402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:28:50.729Z</lastUpdated>
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    <udiDi>D-GCKal-402aNM</udiDi>
    <basicUdiDi>B-GCKal-402aNM</basicUdiDi>
    <tradeName>Leishmania Ab Rapid Test Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Leishmania Ab Rapid Test Cassette (Whole Blood/Serum/Plasma)</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050205</emdnCode>
    <emdnDescription>LEISHMANIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCKal-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:28:49.929Z</lastUpdated>
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    <udiDi>D-GCKal-402aHGWR</udiDi>
    <basicUdiDi>B-GCKal-402aHGWR</basicUdiDi>
    <tradeName>Leishmania Ab Rapid Test Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Leishmania Ab Rapid Test Cassette (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050205</emdnCode>
    <emdnDescription>LEISHMANIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCKal-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:28:45.928Z</lastUpdated>
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    <udiDi>D-GCKal-401aNJ</udiDi>
    <basicUdiDi>B-GCKal-401aNJ</basicUdiDi>
    <tradeName>Leishmania Ab Rapid Test Strip (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Leishmania Ab Rapid Test Strip (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>LEISHMANIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCKal-401a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:28:45.138Z</lastUpdated>
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    <udiDi>D-GCKal-401aHGWJ</udiDi>
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    <tradeName>Leishmania Ab Rapid Test Strip (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Leishmania Ab Rapid Test Strip (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>LEISHMANIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCKal-401a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:28:44.327Z</lastUpdated>
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    <udiDi>D-37700277934272K</udiDi>
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    <tradeName>LEISHMANIA WB IgG</tradeName>
    <deviceName>LEISHMANIA WB IgG</deviceName>
    <manufacturerName>LDBIO DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000021697</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>LEISHMANIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LES-WB96G</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
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    <tradeName>LEISHMANIA WB IgG</tradeName>
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    <manufacturerName>LDBIO DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000021697</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>LEISHMANIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LES-WB12G</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:57:01.835Z</lastUpdated>
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    <tradeName>LEISHMANIA WB IgG</tradeName>
    <deviceName>LEISHMANIA WB IgG</deviceName>
    <manufacturerName>LDBIO DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000021697</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>LES-WB24G</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:57:00.059Z</lastUpdated>
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