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    <tradeName>Allergen-Specific IgE Antibody Kit（Fluorescence flow cytometry）</tradeName>
    <deviceName>Allergen-Specific IgE Antibody Kit（Fluorescence flow cytometry）</deviceName>
    <manufacturerName>Shenzhen Dymind Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024842</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020204</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - MONOTEST/PLURIRESULT-MULTI AG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY-0021-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:32:14.106Z</lastUpdated>
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    <udiDi>06976117454903</udiDi>
    <basicUdiDi>B-06976117454903</basicUdiDi>
    <tradeName>Allergen-Specific IgE Antibody Kit（Fluorescence flow cytometry）</tradeName>
    <deviceName>Allergen-Specific IgE Antibody Kit（Fluorescence flow cytometry）</deviceName>
    <manufacturerName>Shenzhen Dymind Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024842</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020204</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - MONOTEST/PLURIRESULT-MULTI AG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY-0025-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:32:11.806Z</lastUpdated>
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    <udiDi>06976117454880</udiDi>
    <basicUdiDi>B-06976117454880</basicUdiDi>
    <tradeName>Allergen-Specific IgE Antibody Kit（Fluorescence flow cytometry）</tradeName>
    <deviceName>Allergen-Specific IgE Antibody Kit（Fluorescence flow cytometry）</deviceName>
    <manufacturerName>Shenzhen Dymind Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024842</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY-0024-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:31:58.051Z</lastUpdated>
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    <udiDi>06976117454873</udiDi>
    <basicUdiDi>B-06976117454873</basicUdiDi>
    <tradeName>Allergen-Specific IgE Antibody Kit（Fluorescence flow cytometry）</tradeName>
    <deviceName>Allergen-Specific IgE Antibody Kit（Fluorescence flow cytometry）</deviceName>
    <manufacturerName>Shenzhen Dymind Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024842</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020204</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - MONOTEST/PLURIRESULT-MULTI AG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY-0016-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:31:55.649Z</lastUpdated>
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    <udiDi>06976117454866</udiDi>
    <basicUdiDi>B-06976117454866</basicUdiDi>
    <tradeName>Allergen-Specific IgE Antibody Kit（Fluorescence flow cytometry）</tradeName>
    <deviceName>Allergen-Specific IgE Antibody Kit（Fluorescence flow cytometry）</deviceName>
    <manufacturerName>Shenzhen Dymind Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024842</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020204</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - MONOTEST/PLURIRESULT-MULTI AG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY-0024-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:31:54.049Z</lastUpdated>
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    <udiDi>06976117454842</udiDi>
    <basicUdiDi>B-06976117454842</basicUdiDi>
    <tradeName>Allergen-Specific IgE Antibody Kit (Fluorescence flow cytometry）</tradeName>
    <deviceName>Allergen-Specific IgE Antibody Kit (Fluorescence flow cytometry）</deviceName>
    <manufacturerName>Shenzhen Dymind Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024842</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020204</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - MONOTEST/PLURIRESULT-MULTI AG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY-0026-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:31:53.251Z</lastUpdated>
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    <udiDi>06976117454835</udiDi>
    <basicUdiDi>B-06976117454835</basicUdiDi>
    <tradeName>Allergen-Specific IgE Antibody Kit（Fluorescence flow cytometry）</tradeName>
    <deviceName>Allergen-Specific IgE Antibody Kit（Fluorescence flow cytometry）</deviceName>
    <manufacturerName>Shenzhen Dymind Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024842</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020204</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - MONOTEST/PLURIRESULT-MULTI AG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY-0020-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:31:51.646Z</lastUpdated>
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    <udiDi>06976117454811</udiDi>
    <basicUdiDi>B-06976117454811</basicUdiDi>
    <tradeName>Allergen-Specific IgE Antibody Kit（Fluorescence flow cytometry）</tradeName>
    <deviceName>Allergen-Specific IgE Antibody Kit（Fluorescence flow cytometry）</deviceName>
    <manufacturerName>Shenzhen Dymind Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024842</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020204</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - MONOTEST/PLURIRESULT-MULTI AG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY-0023-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:31:49.243Z</lastUpdated>
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    <udiDi>06976117454798</udiDi>
    <basicUdiDi>B-06976117454798</basicUdiDi>
    <tradeName>Allergen-Specific IgE Antibody Kit（Fluorescence flow cytometry）</tradeName>
    <deviceName>Allergen-Specific IgE Antibody Kit（Fluorescence flow cytometry）</deviceName>
    <manufacturerName>Shenzhen Dymind Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024842</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020204</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - MONOTEST/PLURIRESULT-MULTI AG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY-0022-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:31:47.649Z</lastUpdated>
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    <udiDi>06976117454781</udiDi>
    <basicUdiDi>B-06976117454781</basicUdiDi>
    <tradeName>Allergen-Specific IgE Antibody Kit（Fluorescence flow cytometry）</tradeName>
    <deviceName>Allergen-Specific IgE Antibody Kit（Fluorescence flow cytometry）</deviceName>
    <manufacturerName>Shenzhen Dymind Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024842</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020204</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - MONOTEST/PLURIRESULT-MULTI AG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY-0025-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:31:46.845Z</lastUpdated>
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    <udiDi>06976117454774</udiDi>
    <basicUdiDi>B-06976117454774</basicUdiDi>
    <tradeName>Allergen-Specific IgE Antibody Kit（Fluorescence flow cytometry）</tradeName>
    <deviceName>Allergen-Specific IgE Antibody Kit（Fluorescence flow cytometry）</deviceName>
    <manufacturerName>Shenzhen Dymind Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024842</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020204</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - MONOTEST/PLURIRESULT-MULTI AG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY-0022-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:31:45.249Z</lastUpdated>
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    <udiDi>06976045540037</udiDi>
    <basicUdiDi>B-06976045540037</basicUdiDi>
    <tradeName>Total IgE Antibody Assay Kit (Colloidal Gold)</tradeName>
    <deviceName>Total IgE Antibody Assay Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Zhide Mingchuang Biotechnology (Wuxi) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000055042</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>100 tests/box</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:27:16.849Z</lastUpdated>
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    <udiDi>06976045540020</udiDi>
    <basicUdiDi>B-06976045540020</basicUdiDi>
    <tradeName>Total IgE Antibody Assay Kit (Colloidal Gold)</tradeName>
    <deviceName>Total IgE Antibody Assay Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Zhide Mingchuang Biotechnology (Wuxi) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000055042</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>40 tests/box</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:27:16.041Z</lastUpdated>
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    <udiDi>06976045540013</udiDi>
    <basicUdiDi>B-06976045540013</basicUdiDi>
    <tradeName>Total IgE Antibody Assay Kit (Colloidal Gold)</tradeName>
    <deviceName>Total IgE Antibody Assay Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Zhide Mingchuang Biotechnology (Wuxi) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000055042</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>20 tests/box</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:27:15.246Z</lastUpdated>
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    <udiDi>06976045540006</udiDi>
    <basicUdiDi>B-06976045540006</basicUdiDi>
    <tradeName>Total IgE Antibody Assay Kit (Colloidal Gold)</tradeName>
    <deviceName>Total IgE Antibody Assay Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Zhide Mingchuang Biotechnology (Wuxi) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000055042</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>5 tests/box</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:27:11.239Z</lastUpdated>
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    <udiDi>06976043630167</udiDi>
    <basicUdiDi>B-06976043630167</basicUdiDi>
    <tradeName>06976043630167</tradeName>
    <deviceName>Total IgE Assay Kit</deviceName>
    <manufacturerName>iCarbonX IntelliCore (Guangdong) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045482</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>016</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:27:10.444Z</lastUpdated>
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    <basicUdiDi>B-06976043630099</basicUdiDi>
    <tradeName>06976043630099</tradeName>
    <deviceName>Allergen  IgE Profile Kit</deviceName>
    <manufacturerName>iCarbonX IntelliCore (Guangdong) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045482</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020204</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - MONOTEST/PLURIRESULT-MULTI AG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>009</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:26:43.180Z</lastUpdated>
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    <basicUdiDi>B-06976043630082</basicUdiDi>
    <tradeName>06976043630082</tradeName>
    <deviceName>Allergen  IgE Profile Kit</deviceName>
    <manufacturerName>iCarbonX IntelliCore (Guangdong) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045482</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020204</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - MONOTEST/PLURIRESULT-MULTI AG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>008</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:26:40.807Z</lastUpdated>
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    <basicUdiDi>B-06976043630075</basicUdiDi>
    <tradeName>06976043630075</tradeName>
    <deviceName>Allergen  IgE Profile Kit</deviceName>
    <manufacturerName>iCarbonX IntelliCore (Guangdong) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045482</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020204</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - MONOTEST/PLURIRESULT-MULTI AG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>007</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:26:39.979Z</lastUpdated>
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    <udiDi>06975984067445</udiDi>
    <basicUdiDi>B-06975984067445</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>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320511602</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:22:26.791Z</lastUpdated>
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