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<eudamedExport entity="devices">
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    <udiDi>06957290301338</udiDi>
    <basicUdiDi>B-06957290301338</basicUdiDi>
    <tradeName>Docteur B</tradeName>
    <deviceName>One Step HCG Pregnancy Test</deviceName>
    <manufacturerName>Hubei MEIBAO Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000019986</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HCG-M35(1 Test/Kit)</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-24T03:53:03.457Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-100082-1ACVH</udiDi>
    <basicUdiDi>B-100082-1ACVH</basicUdiDi>
    <tradeName>SPERM TEST</tradeName>
    <deviceName>SPERM TEST</deviceName>
    <manufacturerName>PRIMA Lab SA</manufacturerName>
    <manufacturerSrn>CH-MF-000034473</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100082-x</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:38:30.345Z</lastUpdated>
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  <row>
    <udiDi>06974785750631</udiDi>
    <basicUdiDi>B-06974785750631</basicUdiDi>
    <tradeName>hCG (Human Chorionic Gonadotropin) Rapid Test (Urine)</tradeName>
    <deviceName>hCG (Human Chorionic Gonadotropin) Rapid Test (Urine)</deviceName>
    <manufacturerName>Anhui Formaster Biosci Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002305</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WHC-4013</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T03:55:38.281Z</lastUpdated>
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  <row>
    <udiDi>06977005880057</udiDi>
    <basicUdiDi>697700588C00002OZK</basicUdiDi>
    <tradeName>BIOSYNEX</tradeName>
    <deviceName>Early Pregnancy Test</deviceName>
    <manufacturerName>Chembio Biosynex Diagnostics (Hangzhou) Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000039047</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>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>860063</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T13:48:59.552Z</lastUpdated>
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  <row>
    <udiDi>06977005880033</udiDi>
    <basicUdiDi>697700588C00001OZG</basicUdiDi>
    <tradeName>BIOSYNEX</tradeName>
    <deviceName>Simply Pregnancy Test</deviceName>
    <manufacturerName>Chembio Biosynex Diagnostics (Hangzhou) Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000039047</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>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>860061</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T13:48:58.764Z</lastUpdated>
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  <row>
    <udiDi>06977005880088</udiDi>
    <basicUdiDi>697700588C00002OZK</basicUdiDi>
    <tradeName>BIOSYNEX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chembio Biosynex Diagnostics (Hangzhou) Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000039047</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>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>858931</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T13:48:06.374Z</lastUpdated>
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  <row>
    <udiDi>D-IHP-402(AT)AE</udiDi>
    <basicUdiDi>B-IHP-402(AT)AE</basicUdiDi>
    <tradeName>H. pylori Antibody Rapid Test Cassette</tradeName>
    <deviceName>H. pylori Antibody Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHP-402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:37:11.196Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FHC-201(AT)UN</udiDi>
    <basicUdiDi>B-FHC-201(AT)UN</basicUdiDi>
    <tradeName>hCG Pregnancy  Rapid Test Dipstick</tradeName>
    <deviceName>hCG Pregnancy  Rapid Test Dipstick</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FHC-201</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:36:50.378Z</lastUpdated>
  </row>
  <row>
    <udiDi>08001841550701</udiDi>
    <basicUdiDi>4084500CB14QT</basicUdiDi>
    <tradeName>Ultra raný Těhotenský test</tradeName>
    <deviceName>Clearblue Ultra Early Pregnancy Test , Clearblue Pregnancy Test Ultra Early</deviceName>
    <manufacturerName>SPD Swiss Precision Diagnostics GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000025175</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08001841550701</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-21T12:48:43.342Z</lastUpdated>
  </row>
  <row>
    <udiDi>08001841804248</udiDi>
    <basicUdiDi>4084500CB15QV</basicUdiDi>
    <tradeName>Digital Ultra Early Pregnancy Test</tradeName>
    <deviceName>Clearblue Digital Ultra Early Pregnancy Test</deviceName>
    <manufacturerName>SPD Swiss Precision Diagnostics GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000025175</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08001841804248</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-21T12:48:39.563Z</lastUpdated>
  </row>
  <row>
    <udiDi>08006530474245</udiDi>
    <basicUdiDi>4084500CB11/CB11AUR</basicUdiDi>
    <tradeName>Easy Pregnancy Test</tradeName>
    <deviceName>Rapid Detection Pregnancy Test, Easy Pregnancy Test, Pregnancy Test Flip &amp; Click</deviceName>
    <manufacturerName>SPD Swiss Precision Diagnostics GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000025175</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08006530474245</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-21T12:20:40.189Z</lastUpdated>
  </row>
  <row>
    <udiDi>08006530454292</udiDi>
    <basicUdiDi>4084500CB9/CB16XF</basicUdiDi>
    <tradeName>Test Early &amp; Date Pregnancy Tests</tradeName>
    <deviceName>Ultra Early ADVANCED &amp; Weeks Indicator PGTs, Early Detection ADVANCED &amp; Weeks Indicator PGTs, Early Detection ADVANCED &amp; Weeks Indicator PGTs CP, Test &amp; Date PGTs CP, Test Early &amp; Date PGTs, Ultra Early ADVANCED &amp; Weeks Indicator PGTs CP</deviceName>
    <manufacturerName>SPD Swiss Precision Diagnostics GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000025175</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08006530454292</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-21T12:20:39.388Z</lastUpdated>
  </row>
  <row>
    <udiDi>08006530454193</udiDi>
    <basicUdiDi>4084500CB9/CB11/CB16XN</basicUdiDi>
    <tradeName>Schwangerschaftstests 3 mal Gewissheit</tradeName>
    <deviceName>Triple Assurance PGTs, 3x Assurance PGTs, Triple Assurance CP PGTs, 3x Assurance CP PGTs, Triple Check &amp; Date PGTs, 3x Check &amp; Date PGTs, Triple Check &amp; Date CP PGTs, 3x Check &amp; Date CP PGTs</deviceName>
    <manufacturerName>SPD Swiss Precision Diagnostics GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000025175</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08006530454193</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T12:20:38.577Z</lastUpdated>
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  <row>
    <udiDi>08006530340786</udiDi>
    <basicUdiDi>4084500CB14/CB9TL</basicUdiDi>
    <tradeName>Ultra Early &amp; Weeks Indicator Pregnancy Tests</tradeName>
    <deviceName>Ultra Early &amp; Weeks Indicator PGTs, Ultra Early &amp; Weeks Indicator PGTs CP, Early Detection &amp; Weeks Indicator PGTs, Early Detection &amp; Weeks Indicator PGTs CP, Test &amp; Confirm PGTs, Test &amp; Conform PGTs CP</deviceName>
    <manufacturerName>SPD Swiss Precision Diagnostics GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000025175</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08006530340786</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-21T12:20:35.372Z</lastUpdated>
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    <udiDi>08006530255202</udiDi>
    <basicUdiDi>4084500CB16QX</basicUdiDi>
    <tradeName>Ultra Early Advanced Pregnancy Test</tradeName>
    <deviceName>Clearblue Ultra Early Advanced Pregnancy Test</deviceName>
    <manufacturerName>SPD Swiss Precision Diagnostics GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000025175</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08006530255202</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-21T12:20:34.566Z</lastUpdated>
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    <udiDi>08006530244442</udiDi>
    <basicUdiDi>4084500CB11/CB14Q8</basicUdiDi>
    <tradeName>Ultra Early &amp; Rapid Pregnancy Tests</tradeName>
    <deviceName>Ultra Early &amp; Rapid Pregnancy Tests, Ultra Early &amp; Rapid Pregnancy Tests Combo Pack, Early Detection &amp; Rapid Pregnancy Tests, Early Detection &amp; Rapid Pregnancy Tests Combo Pack</deviceName>
    <manufacturerName>SPD Swiss Precision Diagnostics GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000025175</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08006530244442</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-21T12:20:33.780Z</lastUpdated>
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    <udiDi>62230182723354</udiDi>
    <basicUdiDi>B-62230182723354</basicUdiDi>
    <tradeName>HCG Pregnancy Rapid Test Cassette (Serum, Plasma and Urine)</tradeName>
    <deviceName>HCG Pregnancy Rapid Test Cassette (Serum, Plasma and Urine)</deviceName>
    <manufacturerName>Kalians Corporation</manufacturerName>
    <manufacturerSrn>EG-MF-000050142</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-787 001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-20T01:47:58.734Z</lastUpdated>
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    <udiDi>06936020140232</udiDi>
    <basicUdiDi>6936020120BRB</basicUdiDi>
    <tradeName>Singclean®</tradeName>
    <deviceName>Human Chorionic Gonadotropin (HCG) Pregnancy Test Kit(Colloidal Gold)</deviceName>
    <manufacturerName>Hangzhou Singclean Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014098</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HCG10-01-1t</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-19T04:58:22.749Z</lastUpdated>
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    <udiDi>06936020106900</udiDi>
    <basicUdiDi>69360201208J</basicUdiDi>
    <tradeName>Singclean®</tradeName>
    <deviceName>Human Chorionic Gonadotropin (HCG) Pregnancy Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Hangzhou Singclean Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014098</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HCG-02-50t</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-19T04:58:21.157Z</lastUpdated>
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  <row>
    <udiDi>06936020109376</udiDi>
    <basicUdiDi>69360201208J</basicUdiDi>
    <tradeName>Singclean®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Singclean Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014098</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HCG-01-1t</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-19T04:56:42.801Z</lastUpdated>
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</eudamedExport>