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    <tradeName>Sharay Anti-IA2 IgG (CLIA)</tradeName>
    <deviceName>Sharay Anti-IA2 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>W0102060106</emdnCode>
    <emdnDescription>THYROSIN PHOSPHATASE IA2 ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14000888</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:51:31.944Z</lastUpdated>
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    <udiDi>06975070769673</udiDi>
    <basicUdiDi>B-06975070769673</basicUdiDi>
    <tradeName>Sharay Anti-GAD IgG (CLIA)</tradeName>
    <deviceName>Sharay Anti-GAD 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>
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    <emdnDescription>GAD II ANTIBODIES AND OTHER ICA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:51:31.139Z</lastUpdated>
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    <udiDi>06975070769666</udiDi>
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    <tradeName>Sharay Anti-Islet Cell IgG (CLIA)</tradeName>
    <deviceName>Sharay Anti-Islet Cell IgG (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
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    <emdnDescription>ISLET CELL AB</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-06T18:51:27.133Z</lastUpdated>
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    <udiDi>06975070769550</udiDi>
    <basicUdiDi>B-06975070769550</basicUdiDi>
    <tradeName>Sharay Anti-ZnT8 IgG (CLIA)</tradeName>
    <deviceName>Sharay Anti-ZnT8 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>W0102060199</emdnCode>
    <emdnDescription>DIABETES ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14000881</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:51:11.911Z</lastUpdated>
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    <udiDi>06975070763008</udiDi>
    <basicUdiDi>B-06975070763008</basicUdiDi>
    <tradeName>Sharay Insulin (CLIA)</tradeName>
    <deviceName>Sharay Insulin (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>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18721001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:40:10.053Z</lastUpdated>
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    <udiDi>06975070762995</udiDi>
    <basicUdiDi>B-06975070762995</basicUdiDi>
    <tradeName>Sharay C-Peptide (CLIA)</tradeName>
    <deviceName>Sharay C-Peptide (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>W0102060101</emdnCode>
    <emdnDescription>C-PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18720001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:40:07.649Z</lastUpdated>
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    <udiDi>06975070761875</udiDi>
    <basicUdiDi>B-06975070761875</basicUdiDi>
    <tradeName>Sharay Anti-ZnT8 IgG (CLIA)</tradeName>
    <deviceName>Sharay Anti-ZnT8 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>W0102060199</emdnCode>
    <emdnDescription>DIABETES ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18127001</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:36:40.668Z</lastUpdated>
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    <udiDi>06975070761868</udiDi>
    <basicUdiDi>B-06975070761868</basicUdiDi>
    <tradeName>Sharay Anti-Insulin IgG (CLIA)</tradeName>
    <deviceName>Sharay Anti-Insulin 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>W0102060104</emdnCode>
    <emdnDescription>INSULIN ANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18141001</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:36:39.867Z</lastUpdated>
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    <udiDi>06975070761851</udiDi>
    <basicUdiDi>B-06975070761851</basicUdiDi>
    <tradeName>Sharay Anti-IA2 IgG (CLIA)</tradeName>
    <deviceName>Sharay Anti-IA2 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>W0102060106</emdnCode>
    <emdnDescription>THYROSIN PHOSPHATASE IA2 ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18140001</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:36:39.069Z</lastUpdated>
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    <udiDi>06975070761844</udiDi>
    <basicUdiDi>B-06975070761844</basicUdiDi>
    <tradeName>Sharay Anti-GAD IgG (CLIA)</tradeName>
    <deviceName>Sharay Anti-GAD 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>W0102060105</emdnCode>
    <emdnDescription>GAD II ANTIBODIES AND OTHER ICA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18139001</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:36:38.270Z</lastUpdated>
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    <udiDi>06975070761837</udiDi>
    <basicUdiDi>B-06975070761837</basicUdiDi>
    <tradeName>Sharay Anti-Islet Cell IgG (CLIA)</tradeName>
    <deviceName>Sharay Anti-Islet Cell 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>W0102060108</emdnCode>
    <emdnDescription>ISLET CELL AB</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18138001</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:36:34.266Z</lastUpdated>
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    <udiDi>06975068490640</udiDi>
    <basicUdiDi>B-06975068490640</basicUdiDi>
    <tradeName>C-Peptide（C-P）Rapid Quantitative Test（Fluorescence Immunoassay）</tradeName>
    <deviceName>C-Peptide（C-P）Rapid Quantitative Test（Fluorescence Immunoassay）</deviceName>
    <manufacturerName>WWHS Biotech.Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000027179</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060101</emdnCode>
    <emdnDescription>C-PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP081.B1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:31:31.710Z</lastUpdated>
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    <udiDi>06975068490367</udiDi>
    <basicUdiDi>B-06975068490367</basicUdiDi>
    <tradeName>Insulin（INS）Rapid Quantitative Test（Fluorescence Immunoassay）</tradeName>
    <deviceName>Insulin（INS）Rapid Quantitative Test（Fluorescence Immunoassay）</deviceName>
    <manufacturerName>WWHS Biotech.Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000027179</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP080.B1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:30:34.797Z</lastUpdated>
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    <udiDi>06974986814880</udiDi>
    <basicUdiDi>B-06974986814880</basicUdiDi>
    <tradeName>Insulin (INS) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Insulin (INS) 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>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:26:28.751Z</lastUpdated>
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    <udiDi>06974986814873</udiDi>
    <basicUdiDi>B-06974986814873</basicUdiDi>
    <tradeName>Insulin (INS) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Insulin (INS) 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>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:26:27.950Z</lastUpdated>
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    <udiDi>06974986814866</udiDi>
    <basicUdiDi>B-06974986814866</basicUdiDi>
    <tradeName>Insulin (INS) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Insulin (INS) 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>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:26:27.265Z</lastUpdated>
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    <udiDi>06974986814859</udiDi>
    <basicUdiDi>B-06974986814859</basicUdiDi>
    <tradeName>C-Peptide (C-P) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>C-Peptide (C-P) 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>W0102060101</emdnCode>
    <emdnDescription>C-PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:26:22.348Z</lastUpdated>
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    <udiDi>06974986814842</udiDi>
    <basicUdiDi>B-06974986814842</basicUdiDi>
    <tradeName>C-Peptide (C-P) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>C-Peptide (C-P) 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>W0102060101</emdnCode>
    <emdnDescription>C-PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:26:21.552Z</lastUpdated>
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    <udiDi>06974986814835</udiDi>
    <basicUdiDi>B-06974986814835</basicUdiDi>
    <tradeName>C-Peptide (C-P) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>C-Peptide (C-P) 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>W0102060101</emdnCode>
    <emdnDescription>C-PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:26:19.965Z</lastUpdated>
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    <udiDi>06974986812381</udiDi>
    <basicUdiDi>B-06974986812381</basicUdiDi>
    <tradeName>Glycated Hemoglobin Assay Kit （Fluorescence  Immunochromatography）</tradeName>
    <deviceName>Glycated Hemoglobin Assay Kit （Fluorescence  Immunochromatography）</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>W0102060199</emdnCode>
    <emdnDescription>DIABETES ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:18:21.119Z</lastUpdated>
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