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<eudamedExport entity="devices">
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    <udiDi>D-01067</udiDi>
    <basicUdiDi>B-01067</basicUdiDi>
    <tradeName>D-01067</tradeName>
    <deviceName>EasyMagPlex Antiphospholipid Syndrome IgG Kit</deviceName>
    <manufacturerName>Hunan Wellgrow Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045201</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50T/Kit, 50T/Kit(W Control), 100T/Kit, 100T/Kit (W Control), 48T/Kit, 48T/Kit(W Control)</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:08:40.318Z</lastUpdated>
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  <row>
    <udiDi>D-0086L</udiDi>
    <basicUdiDi>B-0086L</basicUdiDi>
    <tradeName>D-0086L</tradeName>
    <deviceName>EasyMagPlex Autoimmune Vasculitis Kit</deviceName>
    <manufacturerName>Hunan Wellgrow Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045201</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50T/Kit, 50T/Kit(W Control), 100T/Kit, 100T/Kit (W Control), 48T/Kit, 48T/Kit(W Control)</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:56:15.631Z</lastUpdated>
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  <row>
    <udiDi>D-0066G</udiDi>
    <basicUdiDi>B-0066G</basicUdiDi>
    <tradeName>D-0066G</tradeName>
    <deviceName>EasyMagPlex Autoimmune Liver Disease Kit</deviceName>
    <manufacturerName>Hunan Wellgrow Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045201</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50T/Kit, 50T/Kit(W Control), 100T/Kit, 100T/Kit (W Control), 48T/Kit, 48T/Kit(W Control)</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:06:14.573Z</lastUpdated>
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  <row>
    <udiDi>48058945154470</udiDi>
    <basicUdiDi>8058945153AU3020AIHM</basicUdiDi>
    <tradeName>Evo Autoimmune SPA</tradeName>
    <deviceName>Autoimmunity SPA - Autoimmunità SPA</deviceName>
    <manufacturerName>ABD SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000029729</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3AU3020 AGA</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:18:45.357Z</lastUpdated>
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  <row>
    <udiDi>07333066014630</udiDi>
    <basicUdiDi>7333066BUDI0025LW</basicUdiDi>
    <tradeName>EliA GBM Well</tradeName>
    <deviceName>EliA GBM</deviceName>
    <manufacturerName>Phadia AB</manufacturerName>
    <manufacturerSrn>SE-MF-000014170</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102109014</emdnCode>
    <emdnDescription>ANTIBODIES TO GLOMERULAR BASAL MEMBRANE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14-5514-01</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:16:13.693Z</lastUpdated>
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  <row>
    <udiDi>04049325029507</udiDi>
    <basicUdiDi>4049325IVR06020002BR4</basicUdiDi>
    <tradeName>MuSK-Ab ELISA</tradeName>
    <deviceName>MuSK-Ab ELISA</deviceName>
    <manufacturerName>IBL International GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000015709</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE51021</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T16:04:16.089Z</lastUpdated>
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  <row>
    <udiDi>04049325008229</udiDi>
    <basicUdiDi>4049325IVR06020001BQZ</basicUdiDi>
    <tradeName>Acetylcholine Receptor Autoantibodies (ARAb) RRA</tradeName>
    <deviceName>Acetylcholine Receptor Autoantibodies (ARAb) RRA</deviceName>
    <manufacturerName>IBL International GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000015709</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102109022</emdnCode>
    <emdnDescription>ACETYLCHOLIN RECEPTOR ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KIPIB21021</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T16:04:12.082Z</lastUpdated>
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  <row>
    <udiDi>04049325033542</udiDi>
    <basicUdiDi>4049325IVR06020001BQZ</basicUdiDi>
    <tradeName>Acetylcholine Receptor Autoantibodies (ARAb) RRA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>IBL International GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000015709</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102109022</emdnCode>
    <emdnDescription>ACETYLCHOLIN RECEPTOR ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30221148</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:40:08.097Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049325033559</udiDi>
    <basicUdiDi>4049325IVR06020001BQZ</basicUdiDi>
    <tradeName>Acetylcholine Receptor Autoantibodies (ARAb) RRA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>IBL International GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000015709</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102109022</emdnCode>
    <emdnDescription>ACETYLCHOLIN RECEPTOR ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30221149</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:40:08.082Z</lastUpdated>
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  <row>
    <udiDi>06970522647936</udiDi>
    <basicUdiDi>B-06970522647936</basicUdiDi>
    <tradeName>Anti-endometrial antibody IgM (EM-IgM) Dectection Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Anti-endometrial antibody IgM (EM-IgM) Dectection Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DB1101</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:47:09.694Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970522647790</udiDi>
    <basicUdiDi>B-06970522647790</basicUdiDi>
    <tradeName>Anti-endometrial antibody IgG (EM-IgG) Dectection Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Anti-endometrial antibody IgG (EM-IgG) Dectection Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DB1001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:47:06.089Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970522640975</udiDi>
    <basicUdiDi>B-06970522640975</basicUdiDi>
    <tradeName>Anti-ovarian antibody IgG (AOA-IgG) Dectection Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Anti-ovarian antibody IgG (AOA-IgG) Dectection Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DB0601</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:45:36.014Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970522640913</udiDi>
    <basicUdiDi>B-06970522640913</basicUdiDi>
    <tradeName>Anti-sperm antibody IgM (ASA-IgM) Dectection Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Anti-sperm antibody IgM (ASA-IgM) Dectection Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102109013</emdnCode>
    <emdnDescription>SPERM ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DB0501</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:45:33.613Z</lastUpdated>
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  <row>
    <udiDi>06970522640791</udiDi>
    <basicUdiDi>B-06970522640791</basicUdiDi>
    <tradeName>Anti-sperm antibody IgG (ASA-IgG) Dectection Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Anti-sperm antibody IgG (ASA-IgG) Dectection Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102109013</emdnCode>
    <emdnDescription>SPERM ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DB0401</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:45:32.411Z</lastUpdated>
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  <row>
    <udiDi>06970522640692</udiDi>
    <basicUdiDi>B-06970522640692</basicUdiDi>
    <tradeName>Anti-ovarian antibody IgM (AOA-IgM) Dectection Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Anti-ovarian antibody IgM (AOA-IgM) Dectection Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DB0701</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:45:30.020Z</lastUpdated>
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  <row>
    <udiDi>06950617403678</udiDi>
    <basicUdiDi>69506174IM441460DZ</basicUdiDi>
    <tradeName>06950617403678</tradeName>
    <deviceName>Anti-GBM Antibody Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102109014</emdnCode>
    <emdnDescription>ANTIBODIES TO GLOMERULAR BASAL MEMBRANE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4415460</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:42:28.656Z</lastUpdated>
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    <udiDi>06950617403661</udiDi>
    <basicUdiDi>69506174IM441460DZ</basicUdiDi>
    <tradeName>06950617403661</tradeName>
    <deviceName>Anti-GBM Antibody Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102109014</emdnCode>
    <emdnDescription>ANTIBODIES TO GLOMERULAR BASAL MEMBRANE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4414460</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:42:27.447Z</lastUpdated>
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    <udiDi>06950617403654</udiDi>
    <basicUdiDi>69506174IM441460DZ</basicUdiDi>
    <tradeName>06950617403654</tradeName>
    <deviceName>Anti-GBM Antibody Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102109014</emdnCode>
    <emdnDescription>ANTIBODIES TO GLOMERULAR BASAL MEMBRANE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4411460</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:42:21.436Z</lastUpdated>
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    <udiDi>06950617403647</udiDi>
    <basicUdiDi>69506174IM441460DZ</basicUdiDi>
    <tradeName>06950617403647</tradeName>
    <deviceName>Anti-GBM Antibody Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102109014</emdnCode>
    <emdnDescription>ANTIBODIES TO GLOMERULAR BASAL MEMBRANE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4410460</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:42:20.529Z</lastUpdated>
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    <udiDi>06942359513340</udiDi>
    <basicUdiDi>697015090000315HC</basicUdiDi>
    <tradeName>Anti-GBM IgG CLIA Microparticles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102109014</emdnCode>
    <emdnDescription>ANTIBODIES TO GLOMERULAR BASAL MEMBRANE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMQ1710</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:51:09.689Z</lastUpdated>
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