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<eudamedExport entity="devices">
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    <udiDi>+ENTIHANM06700_</udiDi>
    <basicUdiDi>B-+ENTIHANM06700_</basicUdiDi>
    <tradeName>+ENTIHANM06700_</tradeName>
    <deviceName>NovaLisa® Hantavirus IgM</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040614</emdnCode>
    <emdnDescription>HANTAVIRUS / BUNYAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HANM0670</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:14:06.872Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIHANG06700W</udiDi>
    <basicUdiDi>B-+ENTIHANG06700W</basicUdiDi>
    <tradeName>+ENTIHANG06700W</tradeName>
    <deviceName>NovaLisa® Hantavirus IgG</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040614</emdnCode>
    <emdnDescription>HANTAVIRUS / BUNYAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HANG0670</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:14:06.068Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTI301140430C</udiDi>
    <basicUdiDi>B-+ENTI301140430C</basicUdiDi>
    <tradeName>+ENTI301140430C</tradeName>
    <deviceName>Hantavirus IgM</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040614</emdnCode>
    <emdnDescription>HANTAVIRUS / BUNYAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30114043</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:06:02.222Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTI301140420B</udiDi>
    <basicUdiDi>B-+ENTI301140420B</basicUdiDi>
    <tradeName>+ENTI301140420B</tradeName>
    <deviceName>Hantavirus IgG</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040614</emdnCode>
    <emdnDescription>HANTAVIRUS / BUNYAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30114042</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:06:01.422Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IHVGM-402G6</udiDi>
    <basicUdiDi>B-IHVGM-402G6</basicUdiDi>
    <tradeName>Hantavirus lgG/lgM Rapid Test Cassette</tradeName>
    <deviceName>Hantavirus lgG/lgM 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>W0105040614</emdnCode>
    <emdnDescription>HANTAVIRUS / BUNYAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHVGM-402</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:09:46.809Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCHV(IgM)-402aVU</udiDi>
    <basicUdiDi>B-GCHV(IgM)-402aVU</basicUdiDi>
    <tradeName>Hantavirus IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Hantavirus IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040614</emdnCode>
    <emdnDescription>HANTAVIRUS / BUNYAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCHV(IgM)-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:28:43.525Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCHV(IgM)-402aHGY5</udiDi>
    <basicUdiDi>B-GCHV(IgM)-402aHGY5</basicUdiDi>
    <tradeName>Hantavirus IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Hantavirus IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040614</emdnCode>
    <emdnDescription>HANTAVIRUS / BUNYAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCHV(IgM)-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:28:39.517Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCHV(IgG/IgM)-402aLS</udiDi>
    <basicUdiDi>B-GCHV(IgG/IgM)-402aLS</basicUdiDi>
    <tradeName>Hantavirus IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Hantavirus IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040614</emdnCode>
    <emdnDescription>HANTAVIRUS / BUNYAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCHV(IgG/IgM)-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:28:38.726Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCHV(IgG/IgM)-402aHGXA</udiDi>
    <basicUdiDi>B-GCHV(IgG/IgM)-402aHGXA</basicUdiDi>
    <tradeName>Hantavirus IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Hantavirus IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040614</emdnCode>
    <emdnDescription>HANTAVIRUS / BUNYAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCHV(IgG/IgM)-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:28:37.959Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-114302LW</udiDi>
    <basicUdiDi>B-114302LW</basicUdiDi>
    <tradeName>Reageana DOBRAVA-HANTAAN IgG EIA</tradeName>
    <deviceName>Reagena DOBRAVA-HANTAAN IgG EIA</deviceName>
    <manufacturerName>Reagena Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000002804</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040614</emdnCode>
    <emdnDescription>HANTAVIRUS / BUNYAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>114302</reference>
    <placedOnMarketCountry>Slovenia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:48:41.523Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-114301LU</udiDi>
    <basicUdiDi>B-114301LU</basicUdiDi>
    <tradeName>Reagena PUUMALA IgG EIA</tradeName>
    <deviceName>Reagena PUUMALA IgG EIA</deviceName>
    <manufacturerName>Reagena Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000002804</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040614</emdnCode>
    <emdnDescription>HANTAVIRUS / BUNYAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>114301</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:48:40.715Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-114202LR</udiDi>
    <basicUdiDi>B-114202LR</basicUdiDi>
    <tradeName>Reagena DOBRAVA-HANTAAN IgM EIA</tradeName>
    <deviceName>Reagena DOBRAVA-HANTAAN IgM EIA</deviceName>
    <manufacturerName>Reagena Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000002804</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040614</emdnCode>
    <emdnDescription>HANTAVIRUS / BUNYAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>114202</reference>
    <placedOnMarketCountry>Slovenia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:48:35.120Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-114201LP</udiDi>
    <basicUdiDi>B-114201LP</basicUdiDi>
    <tradeName>Reagena PUUMALA IgM EIA</tradeName>
    <deviceName>Reagena PUUMALA IgM EIA</deviceName>
    <manufacturerName>Reagena Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000002804</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040614</emdnCode>
    <emdnDescription>HANTAVIRUS / BUNYAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>114201</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:48:34.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971042229381</udiDi>
    <basicUdiDi>B-06971042229381</basicUdiDi>
    <tradeName>Hantavirus Renal Syndrome Type II  Real Time RT-PCR Kit</tradeName>
    <deviceName>Hantavirus Renal Syndrome Type II  Real Time RT-PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040614</emdnCode>
    <emdnDescription>HANTAVIRUS / BUNYAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QR-0236-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:04:23.361Z</lastUpdated>
  </row>
</eudamedExport>