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    <tradeName>Sharay Anti-RA33 IgG (CLIA)</tradeName>
    <deviceName>Sharay Anti-RA33 IgG (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14000772</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:51:55.202Z</lastUpdated>
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    <udiDi>06975070769741</udiDi>
    <basicUdiDi>B-06975070769741</basicUdiDi>
    <tradeName>Sharay Anti-RF IgA/G/M (CLIA)</tradeName>
    <deviceName>Sharay Anti-RF IgA/G/M (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14000737</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:51:53.623Z</lastUpdated>
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    <udiDi>06975070769734</udiDi>
    <basicUdiDi>B-06975070769734</basicUdiDi>
    <tradeName>Sharay Anti-RF IgM (CLIA)</tradeName>
    <deviceName>Sharay Anti-RF IgM (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
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    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:51:52.958Z</lastUpdated>
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    <udiDi>06975070769758</udiDi>
    <basicUdiDi>B-06975070769758</basicUdiDi>
    <tradeName>Sharay Anti-CCP IgG (CLIA)</tradeName>
    <deviceName>Sharay Anti-CCP IgG (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021112</emdnCode>
    <emdnDescription>ANTI-CYCLIC CITRULLINATED PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14000738</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:51:51.324Z</lastUpdated>
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    <udiDi>06975070769727</udiDi>
    <basicUdiDi>B-06975070769727</basicUdiDi>
    <tradeName>Sharay Anti-RF IgG (CLIA)</tradeName>
    <deviceName>Sharay Anti-RF IgG (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14000891</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:51:37.541Z</lastUpdated>
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    <udiDi>06975070769710</udiDi>
    <basicUdiDi>B-06975070769710</basicUdiDi>
    <tradeName>Sharay Anti-RF IgA (CLIA)</tradeName>
    <deviceName>Sharay Anti-RF IgA (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14000771</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:51:33.544Z</lastUpdated>
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    <udiDi>06975070769567</udiDi>
    <basicUdiDi>B-06975070769567</basicUdiDi>
    <tradeName>Sharay Anti-MCV IgG (CLIA)</tradeName>
    <deviceName>Sharay Anti-MCV IgG (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14000736</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:51:12.713Z</lastUpdated>
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    <udiDi>06975070766160</udiDi>
    <basicUdiDi>B-06975070766160</basicUdiDi>
    <tradeName>Sharay HBP (CLIA)</tradeName>
    <deviceName>Sharay HBP (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14000407</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:43:06.346Z</lastUpdated>
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    <udiDi>06975070762605</udiDi>
    <basicUdiDi>B-06975070762605</basicUdiDi>
    <tradeName>Sharay SAA (CLIA)</tradeName>
    <deviceName>Sharay SAA (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18718001</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:38:51.547Z</lastUpdated>
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    <udiDi>06975070761943</udiDi>
    <basicUdiDi>B-06975070761943</basicUdiDi>
    <tradeName>Sharay Anti-RA33 IgG (CLIA)</tradeName>
    <deviceName>Sharay Anti-RA33 IgG (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18148001</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:36:53.473Z</lastUpdated>
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    <udiDi>06975070761936</udiDi>
    <basicUdiDi>B-06975070761936</basicUdiDi>
    <tradeName>Sharay Anti-RF IgA/G/M (CLIA)</tradeName>
    <deviceName>Sharay Anti-RF IgA/G/M (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18146001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:36:52.676Z</lastUpdated>
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    <udiDi>06975070761929</udiDi>
    <basicUdiDi>B-06975070761929</basicUdiDi>
    <tradeName>Sharay Anti-RF IgM (CLIA)</tradeName>
    <deviceName>Sharay Anti-RF IgM (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18145001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:36:51.883Z</lastUpdated>
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    <udiDi>06975070761912</udiDi>
    <basicUdiDi>B-06975070761912</basicUdiDi>
    <tradeName>Sharay Anti-RF IgG (CLIA)</tradeName>
    <deviceName>Sharay Anti-RF IgG (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18144001</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:36:47.890Z</lastUpdated>
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    <udiDi>06975070761905</udiDi>
    <basicUdiDi>B-06975070761905</basicUdiDi>
    <tradeName>Sharay Anti-RF IgA (CLIA)</tradeName>
    <deviceName>Sharay Anti-RF IgA (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18143001</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:36:47.087Z</lastUpdated>
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    <udiDi>06975070761899</udiDi>
    <basicUdiDi>B-06975070761899</basicUdiDi>
    <tradeName>Sharay MMP-3 (CLIA)</tradeName>
    <deviceName>Sharay MMP-3 (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18126001</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:36:46.280Z</lastUpdated>
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    <udiDi>06975070761882</udiDi>
    <basicUdiDi>B-06975070761882</basicUdiDi>
    <tradeName>Sharay Anti-MCV IgG (CLIA)</tradeName>
    <deviceName>Sharay Anti-MCV IgG (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18128001</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:36:45.489Z</lastUpdated>
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    <udiDi>06975070760960</udiDi>
    <basicUdiDi>B-06975070760960</basicUdiDi>
    <tradeName>Sharay Anti-CCP IgG (CLIA)</tradeName>
    <deviceName>Sharay Anti-CCP IgG (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18147001</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:33:07.881Z</lastUpdated>
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    <udiDi>06974986813746</udiDi>
    <basicUdiDi>B-06974986813746</basicUdiDi>
    <tradeName>Serum Amyloid A Protein(SAA) Assay Kit(Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Serum Amyloid A Protein(SAA) Assay Kit(Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Wuhan Life Origin Biotech Joint Stock Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027340</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:21:00.123Z</lastUpdated>
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    <udiDi>06974986813739</udiDi>
    <basicUdiDi>B-06974986813739</basicUdiDi>
    <tradeName>Serum Amyloid A Protein(SAA) Assay Kit(Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Serum Amyloid A Protein(SAA) Assay Kit(Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Wuhan Life Origin Biotech Joint Stock Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027340</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:20:59.321Z</lastUpdated>
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    <udiDi>06974986813722</udiDi>
    <basicUdiDi>B-06974986813722</basicUdiDi>
    <tradeName>Serum Amyloid A Protein(SAA) Assay Kit(Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Serum Amyloid A Protein(SAA) Assay Kit(Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Wuhan Life Origin Biotech Joint Stock Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027340</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:20:58.521Z</lastUpdated>
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