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    <tradeName>ADVIA 120/2120/2120i CSF Reagent</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_CSF Reagent</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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010199</emdnCode>
    <emdnDescription>REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10320459</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:41:00.928Z</lastUpdated>
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    <udiDi>06977698405148</udiDi>
    <basicUdiDi>697769840GKPD0926W</basicUdiDi>
    <tradeName>Diluent used for Hematology Analysis(HAS330)</tradeName>
    <deviceName>Diluent used for Hematology Analysis(HAS330)</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010199</emdnCode>
    <emdnDescription>REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD092</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:00:06.806Z</lastUpdated>
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    <udiDi>06977698405087</udiDi>
    <basicUdiDi>697769840GKPD0916U</basicUdiDi>
    <tradeName>Lyse used for Hematology Analysis （Lyse）</tradeName>
    <deviceName>Lyse used for Hematology Analysis （Lyse）</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010199</emdnCode>
    <emdnDescription>REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD091</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:00:05.990Z</lastUpdated>
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    <udiDi>06977698405032</udiDi>
    <basicUdiDi>697769840GKPD08979</basicUdiDi>
    <tradeName>Cleaner used for Hematology Analysis</tradeName>
    <deviceName>Cleaner used for Hematology Analysis</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010199</emdnCode>
    <emdnDescription>REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD089</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:00:05.196Z</lastUpdated>
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    <udiDi>06977698404981</udiDi>
    <basicUdiDi>697769840GKPD08877</basicUdiDi>
    <tradeName>Lyse used for Hematology Analysis(LH)</tradeName>
    <deviceName>Lyse used for Hematology analysis（LH)</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010199</emdnCode>
    <emdnDescription>REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD088</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:00:04.387Z</lastUpdated>
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    <udiDi>06977698404936</udiDi>
    <basicUdiDi>697769840GKPD08775</basicUdiDi>
    <tradeName>Lyse used for Hematology Analysis（DIFF）</tradeName>
    <deviceName>Lyse used for Hematology Analysis（DIFF）</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010199</emdnCode>
    <emdnDescription>REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD087</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:00:00.394Z</lastUpdated>
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    <udiDi>06977698404929</udiDi>
    <basicUdiDi>697769840GKPD08673</basicUdiDi>
    <tradeName>Diluent used for Hematology Analysis</tradeName>
    <deviceName>Diluent used for Hematology Analysis</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010199</emdnCode>
    <emdnDescription>REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD086</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T18:59:59.595Z</lastUpdated>
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    <udiDi>D-664090QW</udiDi>
    <basicUdiDi>B-664090QW</basicUdiDi>
    <tradeName>CLENZ Solution</tradeName>
    <deviceName>CLENZ Solution</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010199</emdnCode>
    <emdnDescription>REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>664090</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:47:04.063Z</lastUpdated>
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    <udiDi>08809317541020</udiDi>
    <basicUdiDi>B-08809317541020</basicUdiDi>
    <tradeName>ADAMII™-CD3/CD4/CD8 Kit</tradeName>
    <deviceName>ADAMII™-CD3/CD4/CD8 Kit</deviceName>
    <manufacturerName>NanoEntek, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000021903</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010199</emdnCode>
    <emdnDescription>REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CD348K-025</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:43:05.791Z</lastUpdated>
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    <udiDi>08809317541006</udiDi>
    <basicUdiDi>B-08809317541006</basicUdiDi>
    <tradeName>ADAM-rWBC Kit</tradeName>
    <deviceName>ADHK-050</deviceName>
    <manufacturerName>NanoEntek, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000021903</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010199</emdnCode>
    <emdnDescription>REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ADHK-050</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:43:04.195Z</lastUpdated>
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    <udiDi>08809317540634</udiDi>
    <basicUdiDi>B-08809317540634</basicUdiDi>
    <tradeName>ADAMII-CD34 Kit</tradeName>
    <deviceName>CD34K-025</deviceName>
    <manufacturerName>NanoEntek, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000021903</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010199</emdnCode>
    <emdnDescription>REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CD34K-025</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:42:37.768Z</lastUpdated>
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    <udiDi>08809317540276</udiDi>
    <basicUdiDi>B-08809317540276</basicUdiDi>
    <tradeName>08809317540276</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NanoEntek, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000021903</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010199</emdnCode>
    <emdnDescription>REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ADAM-rWBC &amp; ADAM-rWBC Kit</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:42:06.411Z</lastUpdated>
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    <udiDi>08809317540269</udiDi>
    <basicUdiDi>B-08809317540269</basicUdiDi>
    <tradeName>ADAM-rWBC Kit</tradeName>
    <deviceName>AD1K-050</deviceName>
    <manufacturerName>NanoEntek, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000021903</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010199</emdnCode>
    <emdnDescription>REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD1K-050</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:42:05.611Z</lastUpdated>
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    <udiDi>06977698402406</udiDi>
    <basicUdiDi>B-06977698402406</basicUdiDi>
    <tradeName>FOB/TF Rapid Test Cassette(Colloidal Gold)</tradeName>
    <deviceName>FOB/TF Rapid Test Cassette(Colloidal Gold)</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010199</emdnCode>
    <emdnDescription>REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD045</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:28:51.611Z</lastUpdated>
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    <udiDi>06977698402437</udiDi>
    <basicUdiDi>B-06977698402437</basicUdiDi>
    <tradeName>FOB Rapid Test Cassette (Colloidal Gold)</tradeName>
    <deviceName>FOB Rapid Test Cassette (Colloidal Gold)</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0103010199</emdnCode>
    <emdnDescription>REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD046</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:28:49.310Z</lastUpdated>
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    <udiDi>06975838800952</udiDi>
    <basicUdiDi>B-06975838800952</basicUdiDi>
    <tradeName>CRP Assay Kit</tradeName>
    <deviceName>CRP Assay Kit</deviceName>
    <manufacturerName>Zhejiang Pushkang Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042656</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010199</emdnCode>
    <emdnDescription>REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HE50102</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:12:37.416Z</lastUpdated>
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    <udiDi>06975838800938</udiDi>
    <basicUdiDi>B-06975838800938</basicUdiDi>
    <tradeName>SAA Assay Kit</tradeName>
    <deviceName>SAA Assay Kit</deviceName>
    <manufacturerName>Zhejiang Pushkang Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042656</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HE50103</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:12:35.027Z</lastUpdated>
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    <basicUdiDi>B-06975569870088</basicUdiDi>
    <tradeName>06975569870088</tradeName>
    <deviceName>Fully Auto 5-Part Hematology Analyzer</deviceName>
    <manufacturerName>Shenzhen Sinseng Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000024231</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010199</emdnCode>
    <emdnDescription>REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SXHA610</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:39:03.383Z</lastUpdated>
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    <basicUdiDi>B-06975569870040</basicUdiDi>
    <tradeName>06975569870040</tradeName>
    <deviceName>Fully Auto 3-Part Hematology Analyzer</deviceName>
    <manufacturerName>Shenzhen Sinseng Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000024231</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010199</emdnCode>
    <emdnDescription>REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HAS310</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:39:01.780Z</lastUpdated>
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    <udiDi>08054615271005</udiDi>
    <basicUdiDi>805461527IVD0005B8</basicUdiDi>
    <tradeName>Reticulonac</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIHON KOHDEN FIRENZE S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000007607</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010199</emdnCode>
    <emdnDescription>REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MK-110WI</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:11:37.492Z</lastUpdated>
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