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    <deviceName></deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
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    <lastUpdated>2026-07-31T18:03:14.007Z</lastUpdated>
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    <tradeName>Anti-nRNP/Sm IgG CLIA Microparticles</tradeName>
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    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
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    <udiDi>06925912720348</udiDi>
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    <deviceName>iFlash-Ro-52 IgG</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
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    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <tradeName>BlueDot Myositis7 IgG</tradeName>
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    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
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    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
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    <reference>MYO7D-24</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:03:32.481Z</lastUpdated>
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    <udiDi>06924030416836</udiDi>
    <basicUdiDi>6924030BioCLIAAI3N</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Reagent Kit, Mi-2</tradeName>
    <deviceName>BioCLIA Autoimmune Reagent Kit,BioCLIA Autoimmune Calibrator Set, BioCLIA Autoimmune Control Set</deviceName>
    <manufacturerName>HOB Biotech Group Corp., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023974</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100199</emdnCode>
    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY02274</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:28:03.378Z</lastUpdated>
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    <udiDi>D-IM4409254KG</udiDi>
    <basicUdiDi>B-IM4409254KG</basicUdiDi>
    <tradeName>D-IM4409254KG</tradeName>
    <deviceName>Anti-Sm/RNP Antibody Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
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    <lastUpdated>2026-07-13T22:30:24.024Z</lastUpdated>
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    <udiDi>D-CK-2486-100M96</udiDi>
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    <tradeName>D-CK-2486-100M96</tradeName>
    <deviceName>Human anti-salivary gland protein I antibody CLlA Kit (IgM)</deviceName>
    <manufacturerName>Guangzhou Kangrun Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032267</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:06:36.938Z</lastUpdated>
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    <udiDi>D-CK-2486-100G8S</udiDi>
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    <deviceName>Human anti-salivary gland protein I antibody CLlA Kit (IgG)</deviceName>
    <manufacturerName>Guangzhou Kangrun Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032267</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
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    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK-2486-100G</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:06:36.474Z</lastUpdated>
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    <udiDi>D-CK-2486-100A8E</udiDi>
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    <deviceName>Human anti-salivary gland protein I antibody CLlA Kit (IgA)</deviceName>
    <manufacturerName>Guangzhou Kangrun Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032267</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100199</emdnCode>
    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK-2486-100A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:06:34.194Z</lastUpdated>
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    <udiDi>D-CK-2486-050M9Q</udiDi>
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    <tradeName>D-CK-2486-050M9Q</tradeName>
    <deviceName>Human anti-salivary gland protein I antibody CLlA Kit (IgM)</deviceName>
    <manufacturerName>Guangzhou Kangrun Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032267</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK-2486-050M</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:06:31.019Z</lastUpdated>
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    <udiDi>D-CK-2486-050G9C</udiDi>
    <basicUdiDi>B-CK-2486-050G9C</basicUdiDi>
    <tradeName>D-CK-2486-050G9C</tradeName>
    <deviceName>Human anti-salivary gland protein I antibody CLlA Kit (IgG)</deviceName>
    <manufacturerName>Guangzhou Kangrun Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032267</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100199</emdnCode>
    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK-2486-050G</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:06:29.751Z</lastUpdated>
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    <udiDi>D-CK-2486-050A8Y</udiDi>
    <basicUdiDi>B-CK-2486-050A8Y</basicUdiDi>
    <tradeName>D-CK-2486-050A8Y</tradeName>
    <deviceName>Human anti-salivary gland protein I antibody CLlA Kit (IgA)</deviceName>
    <manufacturerName>Guangzhou Kangrun Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032267</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100199</emdnCode>
    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK-2486-050A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:06:29.427Z</lastUpdated>
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  <row>
    <udiDi>D-CK-2485-100M8R</udiDi>
    <basicUdiDi>B-CK-2485-100M8R</basicUdiDi>
    <tradeName>D-CK-2485-100M8R</tradeName>
    <deviceName>Human anti-CA6 antibody CLIA Kit (IgM)</deviceName>
    <manufacturerName>Guangzhou Kangrun Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032267</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100199</emdnCode>
    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK-2485-100M</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:06:26.993Z</lastUpdated>
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    <udiDi>D-CK-2485-100G8D</udiDi>
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    <tradeName>D-CK-2485-100G8D</tradeName>
    <deviceName>Human anti-CA6 antibody CLIA Kit (IgG)</deviceName>
    <manufacturerName>Guangzhou Kangrun Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032267</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100199</emdnCode>
    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK-2485-100G</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:06:24.586Z</lastUpdated>
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    <udiDi>D-CK-2485-100A7Z</udiDi>
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    <tradeName>D-CK-2485-100A7Z</tradeName>
    <deviceName>Human anti-CA6 antibody CLIA Kit (IgA)</deviceName>
    <manufacturerName>Guangzhou Kangrun Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032267</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100199</emdnCode>
    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK-2485-100A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:06:22.987Z</lastUpdated>
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    <udiDi>D-CK-2485-050M9B</udiDi>
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    <tradeName>D-CK-2485-050M9B</tradeName>
    <deviceName>Human anti-CA6 antibody CLIA Kit (IgM)</deviceName>
    <manufacturerName>Guangzhou Kangrun Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032267</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
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    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK-2485-050M</reference>
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    <lastUpdated>2026-07-13T02:06:22.181Z</lastUpdated>
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    <deviceName>Human anti-CA6 antibody CLIA Kit (IgG)</deviceName>
    <manufacturerName>Guangzhou Kangrun Biotech Co., Ltd.</manufacturerName>
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    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK-2485-050G</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:06:20.694Z</lastUpdated>
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    <deviceName>Human anti-CA6 antibody CLIA Kit (IgA)</deviceName>
    <manufacturerName>Guangzhou Kangrun Biotech Co., Ltd.</manufacturerName>
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    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK-2485-050A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:06:18.283Z</lastUpdated>
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    <udiDi>D-CK-2484-100M8C</udiDi>
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    <deviceName>Human anti-parotid secretory protein antibody CLIA Kit (IgM)</deviceName>
    <manufacturerName>Guangzhou Kangrun Biotech Co., Ltd.</manufacturerName>
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    <emdnCode>W0102100199</emdnCode>
    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK-2484-100M</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:06:18.028Z</lastUpdated>
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    <udiDi>D-CK-2484-100G7Y</udiDi>
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    <deviceName>Human anti-parotid secretory protein antibody CLIA Kit (IgG)</deviceName>
    <manufacturerName>Guangzhou Kangrun Biotech Co., Ltd.</manufacturerName>
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    <emdnCode>W0102100199</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK-2484-100G</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:06:18.003Z</lastUpdated>
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