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    <tradeName>GeneMind</tradeName>
    <deviceName>BRCA1 and BRCA2 Gene Mutation Detection Kit ( Reversible Terminator Sequencing)</deviceName>
    <manufacturerName>GeneMind Biosciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025785</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060203</emdnCode>
    <emdnDescription>BRCA 1+2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L000178</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:08:09.816Z</lastUpdated>
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    <udiDi>06974968583186</udiDi>
    <basicUdiDi>B-06974968583186</basicUdiDi>
    <tradeName>DNA Methylation Detection Kit for Human SDC2, ADHFE1 and PPP2R5C Genes （Real-Time PCR）</tradeName>
    <deviceName>DNA Methylation Detection Kit for Human SDC2, ADHFE1 and PPP2R5C Genes （Real-Time PCR）</deviceName>
    <manufacturerName>GeneMind Biosciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025785</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060214</emdnCode>
    <emdnDescription>COLORECTAL CANCER (MSI-H / DMMR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L000045;L000048</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:07:50.623Z</lastUpdated>
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    <udiDi>06974968583209</udiDi>
    <basicUdiDi>B-06974968583209</basicUdiDi>
    <tradeName>Lung Cancer Circulating Tumor DNA Multi-gene Mutation Combined Detection Kit ( Reversible Terminator Sequencing)</tradeName>
    <deviceName>Lung Cancer Circulating Tumor DNA Multi-gene Mutation Combined Detection Kit ( Reversible Terminator Sequencing)</deviceName>
    <manufacturerName>GeneMind Biosciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025785</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L000046</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:07:48.209Z</lastUpdated>
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    <udiDi>06974968583193</udiDi>
    <basicUdiDi>B-06974968583193</basicUdiDi>
    <tradeName>DNA Methylation Detection Kit for Human SDC2, ADHFE1 and PPP2R5C Genes （Real-Time PCR）</tradeName>
    <deviceName>DNA Methylation Detection Kit for Human SDC2, ADHFE1 and PPP2R5C Genes （Real-Time PCR）</deviceName>
    <manufacturerName>GeneMind Biosciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025785</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060214</emdnCode>
    <emdnDescription>COLORECTAL CANCER (MSI-H / DMMR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L000048</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:07:47.495Z</lastUpdated>
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    <udiDi>06974968583179</udiDi>
    <basicUdiDi>B-06974968583179</basicUdiDi>
    <tradeName>Solid Tumor Multi-gene Combined Detection Kit ( Reversible Terminator Sequencing)</tradeName>
    <deviceName>Solid Tumor Multi-gene Combined Detection Kit ( Reversible Terminator Sequencing)</deviceName>
    <manufacturerName>GeneMind Biosciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025785</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L000044</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:07:31.336Z</lastUpdated>
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    <udiDi>06974968583162</udiDi>
    <basicUdiDi>B-06974968583162</basicUdiDi>
    <tradeName>BRCA1 and BRCA2 Gene Mutation Detection Kit ( Reversible Terminator Sequencing)</tradeName>
    <deviceName>BRCA1 and BRCA2 Gene Mutation Detection Kit ( Reversible Terminator Sequencing)</deviceName>
    <manufacturerName>GeneMind Biosciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025785</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060203</emdnCode>
    <emdnDescription>BRCA 1+2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L000043</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:07:30.538Z</lastUpdated>
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    <udiDi>06974870710229</udiDi>
    <basicUdiDi>B-06974870710229</basicUdiDi>
    <tradeName>06974870710229</tradeName>
    <deviceName>TGS Human K-ras Gene Mutation Detection Kit</deviceName>
    <manufacturerName>Wuxi Ruiqi Gene Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027697</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060202</emdnCode>
    <emdnDescription>K-RAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BM150022</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:00:57.896Z</lastUpdated>
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    <udiDi>06974870710212</udiDi>
    <basicUdiDi>B-06974870710212</basicUdiDi>
    <tradeName>06974870710212</tradeName>
    <deviceName>TGS Human B-raf Gene V600E Mutation Detection Kit</deviceName>
    <manufacturerName>Wuxi Ruiqi Gene Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027697</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060214</emdnCode>
    <emdnDescription>COLORECTAL CANCER (MSI-H / DMMR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BM150021</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:00:57.087Z</lastUpdated>
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    <udiDi>06974870710120</udiDi>
    <basicUdiDi>B-06974870710120</basicUdiDi>
    <tradeName>06974870710120</tradeName>
    <deviceName>Human K-ras Gene Mutation Detection Kit (PCR-Melting Curve Method)</deviceName>
    <manufacturerName>Wuxi Ruiqi Gene Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027697</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060202</emdnCode>
    <emdnDescription>K-RAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P112H</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:00:29.016Z</lastUpdated>
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    <udiDi>06974870710113</udiDi>
    <basicUdiDi>B-06974870710113</basicUdiDi>
    <tradeName>06974870710113</tradeName>
    <deviceName>Human B-raf Gene V600E Mutation Detection Kit (Fluorescence PCR Method)</deviceName>
    <manufacturerName>Wuxi Ruiqi Gene Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027697</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060214</emdnCode>
    <emdnDescription>COLORECTAL CANCER (MSI-H / DMMR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P111H</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:00:26.628Z</lastUpdated>
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    <udiDi>06974858560518</udiDi>
    <basicUdiDi>B-06974858560518</basicUdiDi>
    <tradeName>06974858560518</tradeName>
    <deviceName>Human HLA-B*5801 Gene Nucleic Acid Detection Kit (Fluorescence PCR Method)</deviceName>
    <manufacturerName>Suzhou TianLong Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001080</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P127H</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:58:57.703Z</lastUpdated>
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    <udiDi>06974858560501</udiDi>
    <basicUdiDi>B-06974858560501</basicUdiDi>
    <tradeName>06974858560501</tradeName>
    <deviceName>Human HLA-B*1502 Gene Nucleic Acid Detection Kit (Fluorescence PCR Method)</deviceName>
    <manufacturerName>Suzhou TianLong Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001080</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P135H</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:58:56.893Z</lastUpdated>
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    <udiDi>06974858560006</udiDi>
    <basicUdiDi>B-06974858560006</basicUdiDi>
    <tradeName>06974858560006</tradeName>
    <deviceName>Human Survival Motor Neuron 1 (SMN1) Gene Detection Kit (PCR-Melting Curve 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>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P124H</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:57:51.222Z</lastUpdated>
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    <udiDi>06974689627497</udiDi>
    <basicUdiDi>B-06974689627497</basicUdiDi>
    <tradeName>WT1 digital PCR detection kit</tradeName>
    <deviceName>WT1 digital PCR detection kit</deviceName>
    <manufacturerName>TargetingOne Technology (Beijing) Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000028247</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12920-2</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:28:35.574Z</lastUpdated>
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    <udiDi>06974689627480</udiDi>
    <basicUdiDi>B-06974689627480</basicUdiDi>
    <tradeName>BCR-ABL p190/p210/p230 digital PCR detection kit</tradeName>
    <deviceName>BCR-ABL p190/p210/p230 digital PCR detection kit</deviceName>
    <manufacturerName>TargetingOne Technology (Beijing) Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000028247</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060208</emdnCode>
    <emdnDescription>T (9;22)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12946-2</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:28:33.977Z</lastUpdated>
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    <udiDi>06974689627473</udiDi>
    <basicUdiDi>B-06974689627473</basicUdiDi>
    <tradeName>IDH2 mutation digital PCR detection kit</tradeName>
    <deviceName>IDH2 mutation digital PCR detection kit</deviceName>
    <manufacturerName>TargetingOne Technology (Beijing) Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000028247</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12911-2</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:28:31.577Z</lastUpdated>
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    <udiDi>06974689627466</udiDi>
    <basicUdiDi>B-06974689627466</basicUdiDi>
    <tradeName>IDH1 mutation digital PCR detection kit</tradeName>
    <deviceName>IDH1 mutation digital PCR detection kit</deviceName>
    <manufacturerName>TargetingOne Technology (Beijing) Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000028247</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ID01-Y24</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:28:29.974Z</lastUpdated>
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    <udiDi>06974689627459</udiDi>
    <basicUdiDi>B-06974689627459</basicUdiDi>
    <tradeName>AML1-ETO digital PCR detection kit</tradeName>
    <deviceName>AML1-ETO digital PCR detection kit</deviceName>
    <manufacturerName>TargetingOne Technology (Beijing) Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000028247</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12944-2</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:28:29.169Z</lastUpdated>
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    <udiDi>06974689627442</udiDi>
    <basicUdiDi>B-06974689627442</basicUdiDi>
    <tradeName>PML-RARA digital PCR detection kit</tradeName>
    <deviceName>PML-RARA digital PCR detection kit</deviceName>
    <manufacturerName>TargetingOne Technology (Beijing) Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000028247</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12940-2</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:28:27.571Z</lastUpdated>
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    <udiDi>06974689627435</udiDi>
    <basicUdiDi>B-06974689627435</basicUdiDi>
    <tradeName>MYD88 L265P mutation digital PCR detection kit</tradeName>
    <deviceName>MYD88 L265P mutation digital PCR detection kit</deviceName>
    <manufacturerName>TargetingOne Technology (Beijing) Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000028247</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12925-2</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:28:25.160Z</lastUpdated>
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