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    <tradeName>IgE (eCLIA)</tradeName>
    <deviceName>IgE (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320511604</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
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    <basicUdiDi>B-06975984067421</basicUdiDi>
    <tradeName>IgE (eCLIA)</tradeName>
    <deviceName>IgE (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
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    <basicUdiDi>B-06975984067414</basicUdiDi>
    <tradeName>IgE (eCLIA)</tradeName>
    <deviceName>IgE (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
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    <deviceName>Dust Mite Component Allergen specific IgE Multiplex-antibodies Detection Kit (Microarray chip )</deviceName>
    <manufacturerName>Shenzhen Sciarray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000038307</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>IMMUNOGLOBULIN E - SCREEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20 tests/ kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:53:15.592Z</lastUpdated>
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    <udiDi>06975424225725</udiDi>
    <basicUdiDi>B-06975424225725</basicUdiDi>
    <tradeName>Free IgE Assay Kit (Fluorescence Immunoassay)</tradeName>
    <deviceName>Free IgE Assay Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
    <emdnCode>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL245501C</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:43:36.549Z</lastUpdated>
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    <basicUdiDi>B-06975424225718</basicUdiDi>
    <tradeName>Total IgE Assay Kit (Fluorescence Immunoassay)</tradeName>
    <deviceName>Total IgE Assay Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <deviceName>Free IgE Assay Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <deviceName>Total lgE Assay Kit(Fluorescence lmmunoassay)</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL245206</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
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    <basicUdiDi>B-06975424223257</basicUdiDi>
    <tradeName>Free IgE Assay Kit (Fluorescence Immunoassay)</tradeName>
    <deviceName>Free IgE Assay Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
    <emdnCode>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20 tests/ kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:38:55.225Z</lastUpdated>
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    <udiDi>06975424223165</udiDi>
    <basicUdiDi>B-06975424223165</basicUdiDi>
    <tradeName>Total IgE Assay Kit (Fluorescence Immunoassay)</tradeName>
    <deviceName>Total IgE Assay Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20T</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:38:30.723Z</lastUpdated>
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    <udiDi>06975070769253</udiDi>
    <basicUdiDi>B-06975070769253</basicUdiDi>
    <tradeName>Sharay Specific IgE (Mixed Allergens 2) (CLIA)</tradeName>
    <deviceName>Sharay Specific IgE (Mixed Allergens 2) (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>W01020202</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14000874</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:50:21.430Z</lastUpdated>
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    <udiDi>06975070769246</udiDi>
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    <tradeName>Sharay Specific IgE (Mixed Allergens 2) (CLIA)</tradeName>
    <deviceName>Sharay Specific IgE (Mixed Allergens 2) (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
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    <emdnDescription>IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:50:19.029Z</lastUpdated>
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    <basicUdiDi>B-06975070769239</basicUdiDi>
    <tradeName>Sharay Specific IgE (Mixed Allergens 2) (CLIA)</tradeName>
    <deviceName>Sharay Specific IgE (Mixed Allergens 2) (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-06T18:50:17.418Z</lastUpdated>
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    <tradeName>Sharay Specific IgE (Mixed Allergens 2) (CLIA)</tradeName>
    <deviceName>Sharay Specific IgE (Mixed Allergens 2) (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
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    <tradeName>Sharay Specific IgE (Mixed Allergens 2) (CLIA)</tradeName>
    <deviceName>Sharay Specific IgE (Mixed Allergens 2) (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
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    <tradeName>Sharay Specific IgE (Mixed Allergens 2) (CLIA)</tradeName>
    <deviceName>Sharay Specific IgE (Mixed Allergens 2) (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
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    <lastUpdated>2026-07-06T18:50:12.613Z</lastUpdated>
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    <tradeName>Sharay ECP (CLIA)</tradeName>
    <deviceName>Sharay ECP (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
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    <lastUpdated>2026-07-06T18:50:11.009Z</lastUpdated>
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    <tradeName>Sharay Specific IgE (19 Allergens) (CLIA)</tradeName>
    <deviceName>Sharay Specific IgE (19 Allergens) (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
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    <emdnDescription>IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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    <tradeName>Sharay Specific IgE (19 Allergens) (CLIA)</tradeName>
    <deviceName>Sharay Specific IgE (19 Allergens) (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
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    <emdnDescription>IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:49:18.901Z</lastUpdated>
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    <tradeName>Sharay Specific IgE (19 Allergens) (CLIA)</tradeName>
    <deviceName>Sharay Specific IgE (19 Allergens) (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
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    <emdnDescription>IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:49:18.097Z</lastUpdated>
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