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    <deviceName>Influenza A/B Virus RNA Detection Kit (Fluorescence PCR Method)</deviceName>
    <manufacturerName>Suzhou TianLong Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001080</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040504</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P122H</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:58:14.430Z</lastUpdated>
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    <udiDi>06974677694630</udiDi>
    <basicUdiDi>B-06974677694630</basicUdiDi>
    <tradeName>Respiratory Syncytial Virus/HumanParainfluenza Virus /Human Rhinovirus Nucleic Acid Detection Kit (Fluorescent RT-MIRA)</tradeName>
    <deviceName>Respiratory Syncytial Virus/HumanParainfluenza Virus /Human Rhinovirus Nucleic Acid Detection Kit (Fluorescent RT-MIRA)</deviceName>
    <manufacturerName>Shanghai BioGerm Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018164</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-FZ-029-24-1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:23:04.454Z</lastUpdated>
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    <udiDi>06974677694623</udiDi>
    <basicUdiDi>B-06974677694623</basicUdiDi>
    <tradeName>Influenza A/B &amp; RSV Nucleic Acid Detection Kit (Fluorescent RT-MIRA)</tradeName>
    <deviceName>Influenza A/B &amp; RSV Nucleic Acid Detection Kit (Fluorescent RT-MIRA)</deviceName>
    <manufacturerName>Shanghai BioGerm Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018164</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-FZ-034-24-2</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:23:03.655Z</lastUpdated>
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    <udiDi>06974677694616</udiDi>
    <basicUdiDi>B-06974677694616</basicUdiDi>
    <tradeName>Influenza A/B &amp; RSV Nucleic Acid Detection Kit (Fluorescent RT-MIRA)</tradeName>
    <deviceName>Influenza A/B &amp; RSV Nucleic Acid Detection Kit (Fluorescent RT-MIRA)</deviceName>
    <manufacturerName>Shanghai BioGerm Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018164</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040504</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-FZ-034-24-1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:23:02.056Z</lastUpdated>
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    <udiDi>06974677690755</udiDi>
    <basicUdiDi>B-06974677690755</basicUdiDi>
    <tradeName>6-in-1 Respiratory Virus Nucleic Acid Detection Kit (PCR-Fluorescence Probing)</tradeName>
    <deviceName>6-in-1 Respiratory Virus Nucleic Acid Detection Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Shanghai BioGerm Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018164</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040504</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-FZ-019-50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:22:07.562Z</lastUpdated>
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    <udiDi>06974674892527</udiDi>
    <basicUdiDi>B-06974674892527</basicUdiDi>
    <tradeName>Influenza A+B virus Diagnostic Kit (PCR-Fluorescence Probing)</tradeName>
    <deviceName>Influenza A+B virus Diagnostic Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040504</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-01-0012</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:16:24.622Z</lastUpdated>
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    <udiDi>06974674892510</udiDi>
    <basicUdiDi>B-06974674892510</basicUdiDi>
    <tradeName>Influenza A (H1N1) Diagnostic Kit (PCR-Fluorescence Probing)</tradeName>
    <deviceName>Influenza A (H1N1) Diagnostic Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040504</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-01-0011</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:16:19.817Z</lastUpdated>
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    <udiDi>06974238910056</udiDi>
    <basicUdiDi>B-06974238910056</basicUdiDi>
    <tradeName>Sars-CoV-2 &amp; Influenza A+B Combo Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Immuno Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001118</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040504</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HCOFLU021G</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:57:57.297Z</lastUpdated>
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    <udiDi>06971042225444</udiDi>
    <basicUdiDi>B-06971042225444</basicUdiDi>
    <tradeName>IFVA/H1N1/IFVB Test</tradeName>
    <deviceName>IFVA/H1N1/IFVB Test</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040504</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RR-0362-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:57:33.394Z</lastUpdated>
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    <udiDi>00840733101656</udiDi>
    <basicUdiDi>B-00840733101656</basicUdiDi>
    <tradeName>00840733101656</tradeName>
    <deviceName>Immunocard STAT Flu A&amp;B</deviceName>
    <manufacturerName>Princeton BioMeditech Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000048310</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040504</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>782030</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T03:41:16.757Z</lastUpdated>
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    <udiDi>00840733101649</udiDi>
    <basicUdiDi>B-00840733101649</basicUdiDi>
    <tradeName>00840733101649</tradeName>
    <deviceName>Immunocard STAT Flu A&amp;B Nasopharyngeal Wash/Aspirate accessory kit</deviceName>
    <manufacturerName>Princeton BioMeditech Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000048310</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040504</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>781130</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T03:41:15.973Z</lastUpdated>
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    <udiDi>08719326569901</udiDi>
    <basicUdiDi>87193265699PF0970-R5M</basicUdiDi>
    <tradeName>RealAccurate® Quadruplex Influenza PCR Kit</tradeName>
    <deviceName>RealAccurate® Quadruplex Influenza PCR Kit</deviceName>
    <manufacturerName>PathoFinder B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000002704</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040504</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PF0970-R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T16:35:09.156Z</lastUpdated>
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    <udiDi>06974849369595</udiDi>
    <basicUdiDi>697484936W01050405V2</basicUdiDi>
    <tradeName>Freeze-dried Influenza A Virus/Influenza B Virus Nucleic Acid Detection Kit  (Fluorescence PCR)</tradeName>
    <deviceName>Freeze-dried Influenza A Virus/Influenza B Virus Nucleic Acid Detection Kit  (Fluorescence PCR)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040504</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-RT176A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:36:45.680Z</lastUpdated>
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    <udiDi>06973843227917</udiDi>
    <basicUdiDi>697384322BSJ04JG</basicUdiDi>
    <tradeName>Influenza A Virus /Influenza B Virus Nucleic Acid Detection Kit (Fluorescence RT-PCR)</tradeName>
    <deviceName>Influenza A Virus /Influenza B Virus Nucleic Acid Detection Kit (Fluorescence RT-PCR)</deviceName>
    <manufacturerName>Hangzhou Bioer Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019512</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040504</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSJ04L1</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:02:11.969Z</lastUpdated>
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    <basicUdiDi>697349224U2020062B000FE</basicUdiDi>
    <tradeName>EasyNAT Rapid Flu Assay</tradeName>
    <deviceName>EasyNAT Rapid Flu Assay</deviceName>
    <manufacturerName>Ustar Biotechnologies (Hangzhou) Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014615</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040504</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U20206</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:40:15.829Z</lastUpdated>
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    <udiDi>15420045509306</udiDi>
    <basicUdiDi>54200455DIAGPFPARAFLURZ</basicUdiDi>
    <tradeName>Panther Fusion Paraflu Assay</tradeName>
    <deviceName>Panther Fusion Paraflu Assay</deviceName>
    <manufacturerName>Hologic</manufacturerName>
    <manufacturerSrn>US-MF-000001646</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
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    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-04329</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:06:17.377Z</lastUpdated>
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    <tradeName>Panther Fusion Flu A/B/RSV Assay</tradeName>
    <deviceName>Panther Fusion Flu A/B/RSV Assay</deviceName>
    <manufacturerName>Hologic</manufacturerName>
    <manufacturerSrn>US-MF-000001646</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-04328</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:06:10.951Z</lastUpdated>
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    <tradeName>04049095210143</tradeName>
    <deviceName>RIDA®UNITY Parainfluenza</deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UN5805</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:52:48.932Z</lastUpdated>
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    <basicUdiDi>4049095UN05050000PY</basicUdiDi>
    <tradeName>04049095210044</tradeName>
    <deviceName>RIDA®UNITY Flu</deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UN0505</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:52:35.305Z</lastUpdated>
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    <basicUdiDi>B-06970895476096</basicUdiDi>
    <tradeName>06970895476096</tradeName>
    <deviceName>Influenza A and B virus nucleic acid test kit  (Fluorescent Probe-based real-time PCR assay)</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R083T010B0C1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:57:02.986Z</lastUpdated>
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