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<eudamedExport entity="devices">
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    <basicUdiDi>B-++B261CANHCG4120QH</basicUdiDi>
    <tradeName>++B261CANHCG4120QH</tradeName>
    <deviceName>Chorionic Gonadotropin (hCG) ELISA</deviceName>
    <manufacturerName>Diagnostics Biochem Canada Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000032449</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050205</emdnCode>
    <emdnDescription>TOTAL HUMAN CHORIONIC GONADOTROPIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAN-hCG-4120</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:40:16.902Z</lastUpdated>
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    <udiDi>++B261CANE630DQ</udiDi>
    <basicUdiDi>B-++B261CANE630DQ</basicUdiDi>
    <tradeName>++B261CANE630DQ</tradeName>
    <deviceName>Total Estrogens ELISA</deviceName>
    <manufacturerName>Diagnostics Biochem Canada Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000032449</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050299</emdnCode>
    <emdnDescription>PREGNANCY TESTING HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAN-E-630</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:40:04.928Z</lastUpdated>
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    <udiDi>++B261CANE620DM</udiDi>
    <basicUdiDi>B-++B261CANE620DM</basicUdiDi>
    <tradeName>++B261CANE620DM</tradeName>
    <deviceName>Free Estriol ELISA</deviceName>
    <manufacturerName>Diagnostics Biochem Canada Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000032449</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050203</emdnCode>
    <emdnDescription>UNCONJUGATED (FREE) ESTRIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAN-E-620</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:40:04.299Z</lastUpdated>
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    <udiDi>++B261CANE420DB</udiDi>
    <basicUdiDi>B-++B261CANE420DB</basicUdiDi>
    <tradeName>++B261CANE420DB</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Diagnostics Biochem Canada Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000032449</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102050204</emdnCode>
    <emdnDescription>ESTRONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAN-E-420</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:40:03.316Z</lastUpdated>
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  <row>
    <udiDi>08806133046975</udiDi>
    <basicUdiDi>880613300509CE</basicUdiDi>
    <tradeName>AFIAS Total βhCG</tradeName>
    <deviceName>AFIAS Total βhCG</deviceName>
    <manufacturerName>Boditech Med Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000011028</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050205</emdnCode>
    <emdnDescription>TOTAL HUMAN CHORIONIC GONADOTROPIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SMFP-3</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:00:53.878Z</lastUpdated>
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  <row>
    <udiDi>08699195610037</udiDi>
    <basicUdiDi>869919561003LBHG.014V</basicUdiDi>
    <tradeName>Laboquick</tradeName>
    <deviceName>Laboquick Pregnancy Cassette Test</deviceName>
    <manufacturerName>Koroglu Medikal Tibbi Malzemeleri Kozmetik Ithalat Ihracat Sanayi Ve Ticaret Ltd. Sti.</manufacturerName>
    <manufacturerSrn>TR-MF-000032257</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050299</emdnCode>
    <emdnDescription>PREGNANCY TESTING HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LBHG.01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:41:38.686Z</lastUpdated>
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    <udiDi>06975984064178</udiDi>
    <basicUdiDi>69703416803205099K8</basicUdiDi>
    <tradeName>Total β-HCG STAT</tradeName>
    <deviceName>Total β-HCG STAT</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</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>W0102050206</emdnCode>
    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320509301</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:14:16.218Z</lastUpdated>
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  <row>
    <udiDi>06936700410105</udiDi>
    <basicUdiDi>6970297531062AF</basicUdiDi>
    <tradeName>Total β Human Chorionic Gonadotropin test (Up-converting Phosphor Technology)</tradeName>
    <deviceName>Total β Human Chorionic Gonadotropin test (Up-converting Phosphor Technology)</deviceName>
    <manufacturerName>Beijing Hotgen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015566</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050206</emdnCode>
    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HGUPT38</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:09:45.786Z</lastUpdated>
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  <row>
    <udiDi>06936700406740</udiDi>
    <basicUdiDi>697029753301L3</basicUdiDi>
    <tradeName>β-Human Chorionic Gonadotropin test (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>β-Human Chorionic Gonadotropin test (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Beijing Hotgen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015566</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050206</emdnCode>
    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HGCL21</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:09:06.855Z</lastUpdated>
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    <udiDi>06936700403374</udiDi>
    <basicUdiDi>697029753442LN</basicUdiDi>
    <tradeName>Anti-Mullerian Hormone Test (Up-converting Phosphor Technology)</tradeName>
    <deviceName>Anti-Mullerian Hormone Test (Up-converting Phosphor Technology)</deviceName>
    <manufacturerName>Beijing Hotgen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015566</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HGUPT15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:08:18.425Z</lastUpdated>
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    <udiDi>06936700403176</udiDi>
    <basicUdiDi>697029753077LM</basicUdiDi>
    <tradeName>Anti-Mullerian hormone test (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Anti-Mullerian hormone test (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Beijing Hotgen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015566</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HGCL14</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:07:57.087Z</lastUpdated>
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    <udiDi>06951045811479</udiDi>
    <basicUdiDi>69510458SF_AMHVV</basicUdiDi>
    <tradeName>06951045811479</tradeName>
    <deviceName>SuperFlex AMH Kit</deviceName>
    <manufacturerName>Suzhou Sym-Bio Lifescience Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012847</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SY434QG</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:20:16.432Z</lastUpdated>
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    <udiDi>06951045811462</udiDi>
    <basicUdiDi>69510458SF_PlGFBZ</basicUdiDi>
    <tradeName>06951045811462</tradeName>
    <deviceName>SuperFlex PlGF Kit</deviceName>
    <manufacturerName>Suzhou Sym-Bio Lifescience Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012847</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050211</emdnCode>
    <emdnDescription>PLACENTAL GROWTH FACTOR (PRE-ECLAMPSIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SY428QG</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:20:14.835Z</lastUpdated>
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    <udiDi>06903053158701</udiDi>
    <basicUdiDi>69449040004S-AMH*******7J</basicUdiDi>
    <tradeName>Anti-Mullerian Hormone (CLIA)</tradeName>
    <deviceName>Anti-Mullerian Hormone (CLIA)、AMH Control</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</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>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-065972-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:57:40.082Z</lastUpdated>
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    <udiDi>06903053158695</udiDi>
    <basicUdiDi>69449040004S-AMH*******7J</basicUdiDi>
    <tradeName>Anti-Mullerian Hormone (CLIA)</tradeName>
    <deviceName>Anti-Mullerian Hormone (CLIA)、AMH Control</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</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>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-065971-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:53:08.338Z</lastUpdated>
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    <udiDi>06944904047805</udiDi>
    <basicUdiDi>69449040004H-E3********T3</basicUdiDi>
    <tradeName>Estriol (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102050202</emdnCode>
    <emdnDescription>ESTRIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004226-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:44:38.121Z</lastUpdated>
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    <udiDi>06903053157681</udiDi>
    <basicUdiDi>69449040004H-HCG-II****HG</basicUdiDi>
    <tradeName>Total β Human Chorionic Gonadotrophin (CLIA)</tradeName>
    <deviceName>Total β Human Chorionic Gonadotrophin（CLIA）、Total β HCG Calibrators</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</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>W0102050205</emdnCode>
    <emdnDescription>TOTAL HUMAN CHORIONIC GONADOTROPIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-064647-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:36:45.511Z</lastUpdated>
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    <basicUdiDi>692591270077HL</basicUdiDi>
    <tradeName>iFlash-PAPP-A</tradeName>
    <deviceName>iFlash-PAPP-A</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</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>W0102050210</emdnCode>
    <emdnDescription>PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86042</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:35:09.074Z</lastUpdated>
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    <udiDi>06925912719113</udiDi>
    <basicUdiDi>692591270078HN</basicUdiDi>
    <tradeName>iFlash-Unconjugated Estriol</tradeName>
    <deviceName>iFlash-Unconjugated Estriol</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</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>W0102050203</emdnCode>
    <emdnDescription>UNCONJUGATED (FREE) ESTRIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86043</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:35:03.486Z</lastUpdated>
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    <udiDi>06925912719090</udiDi>
    <basicUdiDi>692591270080H9</basicUdiDi>
    <tradeName>iFlash-free βhCG</tradeName>
    <deviceName>iFlash-free βhCG</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</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>W0102050206</emdnCode>
    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86050</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:35:01.075Z</lastUpdated>
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