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<eudamedExport entity="devices">
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    <udiDi>D-0000128071590BASL</udiDi>
    <basicUdiDi>B-0000128071590BASL</basicUdiDi>
    <tradeName>SARS-CoV-2, Respiratory Syncytium, and Influenza A&amp;B Antigen Combined Detection Kit(Latex Method)</tradeName>
    <deviceName>SARS-CoV-2, Respiratory Syncytium, and Influenza A&amp;B Antigen Combined Detection Kit(Latex Method)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-RT152</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:58:41.963Z</lastUpdated>
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    <udiDi>08809240105269</udiDi>
    <basicUdiDi>924010RBIL00002PH</basicUdiDi>
    <tradeName>Allplex™ TS Strep ACG&amp;AH</tradeName>
    <deviceName>Allplex™ TS Strep ACG&amp;AH</deviceName>
    <manufacturerName>Seegene, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022275</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RBIL00002X</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:03:00.418Z</lastUpdated>
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    <udiDi>06975529962617</udiDi>
    <basicUdiDi>697552996CHE-URP26-101NE</basicUdiDi>
    <tradeName>06975529962617</tradeName>
    <deviceName>Upper Respiratory Tract Pathogen Nucleic Acid Detection Kit (Fluorescent PCR-Chip Method)</deviceName>
    <manufacturerName>Shenzhen Chenghui Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000046638</manufacturerSrn>
    <authorisedRepresentativeName>HUMISS TRADING S. L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000040177</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CHE-URP26-101</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:14:43.908Z</lastUpdated>
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    <udiDi>06973315734882</udiDi>
    <basicUdiDi>6973315734882AY</basicUdiDi>
    <tradeName>Logilet Respiratory Pathogen Panel</tradeName>
    <deviceName>Logilet Respiratory Pathogen Panel</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</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>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VD1011</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:29:06.133Z</lastUpdated>
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    <udiDi>06430080370047</udiDi>
    <basicUdiDi>6430080371174MK7</basicUdiDi>
    <tradeName>mariPOC® Quick combi test plate</tradeName>
    <deviceName>mariPOC® Quick combi test plate</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1174M</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:00:14.447Z</lastUpdated>
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  <row>
    <udiDi>06430080370030</udiDi>
    <basicUdiDi>6430080371164MK2</basicUdiDi>
    <tradeName>mariPOC® RTI combi test plate</tradeName>
    <deviceName>mariPOC® RTI combi test plate</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1164M</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:00:13.641Z</lastUpdated>
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    <udiDi>15420045509290</udiDi>
    <basicUdiDi>54200455DIAGPFAdVhMPVRVZ2</basicUdiDi>
    <tradeName>Panther Fusion AdV/hMPV/RV Assay</tradeName>
    <deviceName>Panther Fusion AdV/hMPV/RV Assay</deviceName>
    <manufacturerName>Hologic</manufacturerName>
    <manufacturerSrn>US-MF-000001646</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-04330</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:06:16.560Z</lastUpdated>
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    <udiDi>04053228047438</udiDi>
    <basicUdiDi>4053228RRPSC2QST0000001PM</basicUdiDi>
    <tradeName>QIAstat-Dx Respiratory SARS-CoV-2 Panel</tradeName>
    <deviceName>QIAstat-Dx Respiratory SARS-CoV-2 Panel</deviceName>
    <manufacturerName>QIAGEN GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>691215</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T16:23:38.054Z</lastUpdated>
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  <row>
    <udiDi>04049095210136</udiDi>
    <basicUdiDi>4049095UN27050000S8</basicUdiDi>
    <tradeName>04049095210136</tradeName>
    <deviceName>RIDA®UNITY CAP Bac</deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UN2705</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:52:44.917Z</lastUpdated>
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    <udiDi>04049095160615</udiDi>
    <basicUdiDi>4049095PG27050000GN</basicUdiDi>
    <tradeName>04049095160615</tradeName>
    <deviceName>RIDA®GENE CAP Bac</deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PG2705</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:52:22.507Z</lastUpdated>
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  <row>
    <udiDi>08680018943180</udiDi>
    <basicUdiDi>868001894PCRRESCAPPN1004N</basicUdiDi>
    <tradeName>Anatolia Geneworks</tradeName>
    <deviceName>Bosphore Atypical CAP Panel Kit</deviceName>
    <manufacturerName>Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S.</manufacturerName>
    <manufacturerSrn>TR-MF-000022487</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABCAP2</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T14:06:44.023Z</lastUpdated>
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  <row>
    <udiDi>08680018943173</udiDi>
    <basicUdiDi>868001894PCRRESCAPPN1004N</basicUdiDi>
    <tradeName>Anatolia Geneworks</tradeName>
    <deviceName>Bosphore Atypical CAP Panel Kit</deviceName>
    <manufacturerName>Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S.</manufacturerName>
    <manufacturerSrn>TR-MF-000022487</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABCAP1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T14:06:42.851Z</lastUpdated>
  </row>
  <row>
    <udiDi>08680018941346</udiDi>
    <basicUdiDi>868001894PCRRESCAPPN1004N</basicUdiDi>
    <tradeName>Anatolia Geneworks</tradeName>
    <deviceName>Bosphore Atypical CAP Panel Kit</deviceName>
    <manufacturerName>Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S.</manufacturerName>
    <manufacturerSrn>TR-MF-000022487</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABCAP3</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T14:06:26.012Z</lastUpdated>
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  <row>
    <udiDi>06970895476041</udiDi>
    <basicUdiDi>B-06970895476041</basicUdiDi>
    <tradeName>06970895476041</tradeName>
    <deviceName>Multi Respiratory Pathogen Real Time PCR Detection Kit</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R23203T2012</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:56:54.579Z</lastUpdated>
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  <row>
    <udiDi>06970895476010</udiDi>
    <basicUdiDi>B-06970895476010</basicUdiDi>
    <tradeName>06970895476010</tradeName>
    <deviceName>2019-Novel Coronavirus, 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>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R20803T2048</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:56:46.174Z</lastUpdated>
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    <udiDi>06970895475907</udiDi>
    <basicUdiDi>B-06970895475907</basicUdiDi>
    <tradeName>06970895475907</tradeName>
    <deviceName>Multi Respiratory Pathogen Real Time PCR Detection Kit</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R23203T2012</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:56:18.549Z</lastUpdated>
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    <udiDi>06970895475778</udiDi>
    <basicUdiDi>B-06970895475778</basicUdiDi>
    <tradeName>06970895475778</tradeName>
    <deviceName>Multi Respiratory Pathogen Real Time PCR Detection Kit</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R23102T2024</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:56:05.338Z</lastUpdated>
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    <udiDi>06970895475747</udiDi>
    <basicUdiDi>B-06970895475747</basicUdiDi>
    <tradeName>06970895475747</tradeName>
    <deviceName>Multi Respiratory Pathogen Real Time PCR Detection Kit</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R23104C2024</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:55:56.945Z</lastUpdated>
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    <udiDi>06970895475730</udiDi>
    <basicUdiDi>B-06970895475730</basicUdiDi>
    <tradeName>06970895475730</tradeName>
    <deviceName>Multi Respiratory Pathogen Real Time PCR Detection Kit</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R23103C2024</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:55:55.736Z</lastUpdated>
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    <udiDi>06970895475587</udiDi>
    <basicUdiDi>B-06970895475587</basicUdiDi>
    <tradeName>06970895475587</tradeName>
    <deviceName>Multi Respiratory Pathogen Real Time PCR Detection Kit</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R23202T2012</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:55:26.908Z</lastUpdated>
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