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    <basicUdiDi>542502368BDDGADYB</basicUdiDi>
    <tradeName>BlueDiverDot GAD IgG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100299</emdnCode>
    <emdnDescription>NEURO-AUTO-IMMUNE DISEASE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GADIV-24 IgG</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:03:51.688Z</lastUpdated>
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    <udiDi>05425023680704</udiDi>
    <basicUdiDi>542502368BDGADZC</basicUdiDi>
    <tradeName>BlueDot GAD IgG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100299</emdnCode>
    <emdnDescription>NEURO-AUTO-IMMUNE DISEASE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAD-24</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:03:30.877Z</lastUpdated>
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    <udiDi>00630414635439</udiDi>
    <basicUdiDi>0405686902255VL</basicUdiDi>
    <tradeName>ADVIA Centaur Neurofilament Light Chain (NfL)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_KIT_sNfL 100T Kit</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100299</emdnCode>
    <emdnDescription>NEURO-AUTO-IMMUNE DISEASE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11553990</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:36:59.160Z</lastUpdated>
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    <udiDi>06975070767969</udiDi>
    <basicUdiDi>B-06975070767969</basicUdiDi>
    <tradeName>Sharay Anti-Neuronal Antibody Profile IgG (CLIA)</tradeName>
    <deviceName>Sharay Anti-Neuronal Antibody Profile 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>W0102100299</emdnCode>
    <emdnDescription>NEURO-AUTO-IMMUNE DISEASE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18189002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:46:56.696Z</lastUpdated>
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    <udiDi>06975070767952</udiDi>
    <basicUdiDi>B-06975070767952</basicUdiDi>
    <tradeName>Sharay Anti-Neuronal Antibody Profile IgG (CLIA)</tradeName>
    <deviceName>Sharay Anti-Neuronal Antibody Profile 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>W0102100299</emdnCode>
    <emdnDescription>NEURO-AUTO-IMMUNE DISEASE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18188002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:46:55.894Z</lastUpdated>
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    <udiDi>06975070767945</udiDi>
    <basicUdiDi>B-06975070767945</basicUdiDi>
    <tradeName>Sharay Anti-Neuronal Antibody Profile IgG (CLIA)</tradeName>
    <deviceName>Sharay Anti-Neuronal Antibody Profile 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>W0102100299</emdnCode>
    <emdnDescription>NEURO-AUTO-IMMUNE DISEASE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18187002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:46:55.096Z</lastUpdated>
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    <udiDi>06975070767938</udiDi>
    <basicUdiDi>B-06975070767938</basicUdiDi>
    <tradeName>Sharay Anti-Neuronal Antibody Profile IgG (CLIA)</tradeName>
    <deviceName>Sharay Anti-Neuronal Antibody Profile 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>W0102100210</emdnCode>
    <emdnDescription>ANTI-YO ANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18186002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:46:54.292Z</lastUpdated>
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    <udiDi>06975070767921</udiDi>
    <basicUdiDi>B-06975070767921</basicUdiDi>
    <tradeName>Sharay Anti-Neuronal Antibody Profile IgG (CLIA)</tradeName>
    <deviceName>Sharay Anti-Neuronal Antibody Profile 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>W0102100211</emdnCode>
    <emdnDescription>ANTI-RI ANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18185002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:46:49.494Z</lastUpdated>
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  <row>
    <udiDi>06975070767914</udiDi>
    <basicUdiDi>B-06975070767914</basicUdiDi>
    <tradeName>Sharay Anti-Neuronal Antibody Profile IgG (CLIA)</tradeName>
    <deviceName>Sharay Anti-Neuronal Antibody Profile 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>W0102100209</emdnCode>
    <emdnDescription>ANTI-HU ANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18184002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:46:48.688Z</lastUpdated>
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  <row>
    <udiDi>06975070763268</udiDi>
    <basicUdiDi>B-06975070763268</basicUdiDi>
    <tradeName>Sharay Anti-MBP IgG</tradeName>
    <deviceName>Sharay Anti-MBP IgG</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>W0102100299</emdnCode>
    <emdnDescription>NEURO-AUTO-IMMUNE DISEASE - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>18520001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:40:58.135Z</lastUpdated>
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    <udiDi>06975070763244</udiDi>
    <basicUdiDi>B-06975070763244</basicUdiDi>
    <tradeName>Sharay Anti-AQP4 IgG</tradeName>
    <deviceName>Sharay Anti-AQP4 IgG</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>W0102100299</emdnCode>
    <emdnDescription>NEURO-AUTO-IMMUNE DISEASE - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>18518001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:40:57.332Z</lastUpdated>
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    <udiDi>06975070761806</udiDi>
    <basicUdiDi>B-06975070761806</basicUdiDi>
    <tradeName>Sharay Anti-Neuronal Antibody Profile IgG (CLIA)</tradeName>
    <deviceName>Sharay Anti-Neuronal Antibody Profile 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>W0102100299</emdnCode>
    <emdnDescription>NEURO-AUTO-IMMUNE DISEASE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18189001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:36:31.865Z</lastUpdated>
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  <row>
    <udiDi>06975070761790</udiDi>
    <basicUdiDi>B-06975070761790</basicUdiDi>
    <tradeName>Sharay Anti-Neuronal Antibody Profile IgG (CLIA)</tradeName>
    <deviceName>Sharay Anti-Neuronal Antibody Profile 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>W0102100299</emdnCode>
    <emdnDescription>NEURO-AUTO-IMMUNE DISEASE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18188001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:36:27.864Z</lastUpdated>
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    <udiDi>06975070761783</udiDi>
    <basicUdiDi>B-06975070761783</basicUdiDi>
    <tradeName>Sharay Anti-Neuronal Antibody Profile IgG (CLIA)</tradeName>
    <deviceName>Sharay Anti-Neuronal Antibody Profile 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>W0102100299</emdnCode>
    <emdnDescription>NEURO-AUTO-IMMUNE DISEASE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18187001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:36:27.166Z</lastUpdated>
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    <udiDi>06975070761776</udiDi>
    <basicUdiDi>B-06975070761776</basicUdiDi>
    <tradeName>Sharay Anti-Neuronal Antibody Profile IgG (CLIA)</tradeName>
    <deviceName>Sharay Anti-Neuronal Antibody Profile 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>W0102100210</emdnCode>
    <emdnDescription>ANTI-YO ANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18186001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:36:25.457Z</lastUpdated>
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    <udiDi>06975070761769</udiDi>
    <basicUdiDi>B-06975070761769</basicUdiDi>
    <tradeName>Sharay Anti-Neuronal Antibody Profile IgG (CLIA)</tradeName>
    <deviceName>Sharay Anti-Neuronal Antibody Profile 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>W0102100211</emdnCode>
    <emdnDescription>ANTI-RI ANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18185001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:36:24.662Z</lastUpdated>
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    <udiDi>06975070761752</udiDi>
    <basicUdiDi>B-06975070761752</basicUdiDi>
    <tradeName>Sharay Anti-Neuronal Antibody Profile IgG (CLIA)</tradeName>
    <deviceName>Sharay Anti-Neuronal Antibody Profile 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>W0102100209</emdnCode>
    <emdnDescription>ANTI-HU ANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18184001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:36:20.658Z</lastUpdated>
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    <udiDi>00630414635446</udiDi>
    <basicUdiDi>0405686902255VL</basicUdiDi>
    <tradeName>Atellica IM Neurofilament Light Chain (NfL)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100299</emdnCode>
    <emdnDescription>NEURO-AUTO-IMMUNE DISEASE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11553991</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:45:32.764Z</lastUpdated>
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    <udiDi>05425023687147</udiDi>
    <basicUdiDi>542502368BDGADZC</basicUdiDi>
    <tradeName>Stiffman GAD I + GAD II IgG Dot</tradeName>
    <deviceName></deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102100299</emdnCode>
    <emdnDescription>NEURO-AUTO-IMMUNE DISEASE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD GAD</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:23:50.294Z</lastUpdated>
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    <udiDi>05425023687444</udiDi>
    <basicUdiDi>542502368BDDGADYB</basicUdiDi>
    <tradeName>Stiffman GADI + GADII IgG Dot for BDI</tradeName>
    <deviceName></deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102100299</emdnCode>
    <emdnDescription>NEURO-AUTO-IMMUNE DISEASE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD GADBD</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:23:49.697Z</lastUpdated>
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