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    <manufacturerName>Phadia AB</manufacturerName>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <lastUpdated>2026-07-03T01:16:07.288Z</lastUpdated>
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    <basicUdiDi>7333066BUDI0075MD</basicUdiDi>
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    <manufacturerName>Phadia AB</manufacturerName>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>ANTI-CENTROMERE ANTIBODIES</emdnDescription>
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    <reference>14-5505-01</reference>
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    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>14-5503-01</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:16:01.680Z</lastUpdated>
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    <udiDi>07333066014524</udiDi>
    <basicUdiDi>7333066BUDI0072M7</basicUdiDi>
    <tradeName>EliA U1RNP Well</tradeName>
    <deviceName>EliA U1RNP</deviceName>
    <manufacturerName>Phadia AB</manufacturerName>
    <manufacturerSrn>SE-MF-000014170</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100114</emdnCode>
    <emdnDescription>U1-SNRNP - ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14-5501-01</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:16:00.881Z</lastUpdated>
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    <udiDi>06973224892543</udiDi>
    <basicUdiDi>6973224890033A9</basicUdiDi>
    <tradeName>06973224892543</tradeName>
    <deviceName>iStar-dsDNA IgG</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100105</emdnCode>
    <emdnDescription>DS DNA - ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76062</reference>
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    <basicUdiDi>6973224890032A7</basicUdiDi>
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    <deviceName>iStar-ANA</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
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    <riskClass>IVD Sınıf B</riskClass>
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    <emdnDescription>ANA SCREENING</emdnDescription>
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    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:25:44.494Z</lastUpdated>
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    <manufacturerName>IBL International GmbH</manufacturerName>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>DS DNA - ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KIPIB19011</reference>
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    <tradeName>dsDNA-Ab RIA</tradeName>
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    <manufacturerName>IBL International GmbH</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100105</emdnCode>
    <emdnDescription>DS DNA - ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE19011</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:40:08.230Z</lastUpdated>
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    <udiDi>06924030416966</udiDi>
    <basicUdiDi>6924030BioCLIAAI3N</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Reagent Kit, IgG4</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOB Biotech Group Corp., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023974</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102100199</emdnCode>
    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY02291</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:00:55.778Z</lastUpdated>
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    <udiDi>06924030416959</udiDi>
    <basicUdiDi>6924030BioCLIAAI3N</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Reagent Kit, IgG4</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOB Biotech Group Corp., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023974</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:00:52.895Z</lastUpdated>
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    <basicUdiDi>6924030BioCLIAAI3N</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, IgG4</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOB Biotech Group Corp., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023974</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf B</riskClass>
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    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY02293</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:00:39.160Z</lastUpdated>
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    <udiDi>06924030416980</udiDi>
    <basicUdiDi>6924030BioCLIAAI3N</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, IgG4</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOB Biotech Group Corp., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023974</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnCode>W0102100199</emdnCode>
    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>MY02295</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:00:38.648Z</lastUpdated>
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    <udiDi>06924030416997</udiDi>
    <basicUdiDi>6924030BioCLIAAI3N</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Control Set, IgG4</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOB Biotech Group Corp., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023974</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY02294</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:00:37.849Z</lastUpdated>
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    <basicUdiDi>6924030BioCLIAAI3N</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Control Set, IgG4</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOB Biotech Group Corp., Ltd.</manufacturerName>
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    <reference>MY02296</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:00:37.277Z</lastUpdated>
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    <basicUdiDi>6924030BioCLIAAI3N</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, C1q</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOB Biotech Group Corp., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023974</manufacturerSrn>
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    <reference>MY02287</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T03:38:17.222Z</lastUpdated>
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    <tradeName>BioCLIA Autoimmune Calibrator Set, C1q</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOB Biotech Group Corp., Ltd.</manufacturerName>
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    <reference>MY02289</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T03:38:15.340Z</lastUpdated>
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    <basicUdiDi>6924030BioCLIAAI3N</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Reagent Kit, MDA5 (Chemiluminescent Microparticle Immunoassay)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOB Biotech Group Corp., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023974</manufacturerSrn>
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    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY02288</reference>
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    <tradeName>BioCLIA Autoimmune Control Set, C1q</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOB Biotech Group Corp., Ltd.</manufacturerName>
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    <legislation>UNKNOWN</legislation>
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    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
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    <reference>MY02290</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T03:37:48.952Z</lastUpdated>
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    <tradeName>06950617407034</tradeName>
    <deviceName>Anti-Scl-70 Antibody Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100110</emdnCode>
    <emdnDescription>SCL-70</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4422259</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:45:01.146Z</lastUpdated>
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