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<eudamedExport entity="devices">
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    <udiDi>06972412619641</udiDi>
    <basicUdiDi>0697241261IRS-572BQ</basicUdiDi>
    <tradeName>LYHER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Laihe Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033566</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>303041901-40</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:53:22.707Z</lastUpdated>
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  <row>
    <udiDi>06972412611539</udiDi>
    <basicUdiDi>0697241261IRS-RA5229P</basicUdiDi>
    <tradeName>LYHER</tradeName>
    <deviceName>Respiratory multiple 2 in 1 test kit (RSV/Adeno)</deviceName>
    <manufacturerName>Hangzhou Laihe Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033566</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>303045201-20</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-21T04:39:16.170Z</lastUpdated>
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    <udiDi>06972412611485</udiDi>
    <basicUdiDi>0697241261IRS-562BM</basicUdiDi>
    <tradeName>LYHER</tradeName>
    <deviceName>Respiratory multiple 6 in 1 test kit  (FluA/FluB/COVID-19/RSV/Adeno/MP)</deviceName>
    <manufacturerName>Hangzhou Laihe Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033566</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>303034801-20</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-21T04:39:15.375Z</lastUpdated>
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    <udiDi>06972412617159</udiDi>
    <basicUdiDi>0697241261IRS-RA5229P</basicUdiDi>
    <tradeName>LYHER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Laihe Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033566</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>URINE SEDIMENTTEST KIT (MANUAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>303045201-05</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T04:29:38.796Z</lastUpdated>
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    <udiDi>06972412618309</udiDi>
    <basicUdiDi>0697241261IRS-RA5229P</basicUdiDi>
    <tradeName>LYHER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Laihe Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033566</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>URINE SEDIMENTTEST KIT (MANUAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>303045201-40</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T04:29:37.384Z</lastUpdated>
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  <row>
    <udiDi>06972412611546</udiDi>
    <basicUdiDi>0697241261IRS-RA5229P</basicUdiDi>
    <tradeName>LYHER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Laihe Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033566</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>URINE SEDIMENTTEST KIT (MANUAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>303045201-25</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T04:29:36.880Z</lastUpdated>
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  <row>
    <udiDi>06972412618347</udiDi>
    <basicUdiDi>0697241261IRS-562BM</basicUdiDi>
    <tradeName>LYHER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Laihe Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033566</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>303034801-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T04:29:17.067Z</lastUpdated>
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  <row>
    <udiDi>06972412614790</udiDi>
    <basicUdiDi>0697241261IRS-562BM</basicUdiDi>
    <tradeName>LYHER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Laihe Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033566</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>303034801-05</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T04:29:16.603Z</lastUpdated>
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  <row>
    <udiDi>06976232252194</udiDi>
    <basicUdiDi>B-06976232252194</basicUdiDi>
    <tradeName>Acmex</tradeName>
    <deviceName>Covid-19/Influenza A+B/RSV Antigen Combo Rapid Test</deviceName>
    <manufacturerName>Acmex Bio-Technology (Chongqing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037745</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA03-88-422P20</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-17T03:22:19.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RV-G45bZV</udiDi>
    <basicUdiDi>B-RV-G45bZV</basicUdiDi>
    <tradeName>COVID-19/ InfluenzaA+B/RSV Antigen Combo Rapid Test</tradeName>
    <deviceName>COVID-19/ Influenza A+B/RSV Antigen Combo Rapid Test</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RV-G45b</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:09:58.332Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IRTC-595(SSW)F9</udiDi>
    <basicUdiDi>B-IRTC-595(SSW)F9</basicUdiDi>
    <tradeName>Multiplex Respiratory Antigen Rapid Test (Flu B/Flu A/HPIV 1/3/HPIV 2/HMPV/Adeno/MP/RSV/COVID-19)</tradeName>
    <deviceName>Multiplex Respiratory Antigen Rapid Test (Flu B/Flu A/HPIV 1/3/HPIV 2/HMPV/Adeno/MP/RSV/COVID-19)</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IRTC-595(SSW)</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:04:10.187Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A5399</udiDi>
    <basicUdiDi>B-A5399</basicUdiDi>
    <tradeName>D-A5399</tradeName>
    <deviceName>INDICAID™ Respiratory 12-in-1 Rapid Antigen Test</deviceName>
    <manufacturerName>Phase Scientific International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000025791</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INDICAID™ Respiratory 12-in-1 Rapid Antigen Test</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:43:56.688Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A5297</udiDi>
    <basicUdiDi>B-A5297</basicUdiDi>
    <tradeName>D-A5297</tradeName>
    <deviceName>INDICAID™ Respiratory 12-in-1 Rapid Antigen Test (Children Edition)</deviceName>
    <manufacturerName>Phase Scientific International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000025791</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INDICAID™ Respiratory 12-in-1 Rapid Antigen Test (Children Edition)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:43:52.519Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A042CX</udiDi>
    <basicUdiDi>B-A042CX</basicUdiDi>
    <tradeName>D-A042CX</tradeName>
    <deviceName>INDICAID™ HPV Virus Staining Test</deviceName>
    <manufacturerName>Phase Scientific International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000025791</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INDICAID™ HPV Virus Staining Test</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:42:01.989Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A040CT</udiDi>
    <basicUdiDi>B-A040CT</basicUdiDi>
    <tradeName>D-A040CT</tradeName>
    <deviceName>INDICAID™ Respiratory 6-in-1 Rapid Antigen Test</deviceName>
    <manufacturerName>Phase Scientific International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000025791</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INDICAID™ Respiratory 6-in-1 Rapid Antigen Test</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:41:57.409Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A039DA</udiDi>
    <basicUdiDi>B-A039DA</basicUdiDi>
    <tradeName>D-A039DA</tradeName>
    <deviceName>INDICAID™ Multiple Respiratory Pathogen Rapid Antigen Test</deviceName>
    <manufacturerName>Phase Scientific International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000025791</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INDICAID™ Multiple Respiratory Pathogen Rapid Antigen Test</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:41:55.845Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A041CV</udiDi>
    <basicUdiDi>B-A041CV</basicUdiDi>
    <tradeName>D-A041CV</tradeName>
    <deviceName>INDICAID™ Respiratory 8-in-1 Rapid Antigen Test</deviceName>
    <manufacturerName>Phase Scientific International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000025791</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INDICAID™ Respiratory 8-in-1 Rapid Antigen Test</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:41:54.352Z</lastUpdated>
  </row>
  <row>
    <udiDi>69743840313772</udiDi>
    <basicUdiDi>B-69743840313772</basicUdiDi>
    <tradeName>COVID-19 /Flu A&amp;B /RSV /ADENO/M.P Ag Combo Rapid Test Cassette (Swab)</tradeName>
    <deviceName>COVID-19 /Flu A&amp;B /RSV /ADENO/M.P Ag Combo Rapid Test Cassette (Swab)</deviceName>
    <manufacturerName>Zhejiang Anji Saianfu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045029</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3024201</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:13:33.388Z</lastUpdated>
  </row>
  <row>
    <udiDi>69743840313604</udiDi>
    <basicUdiDi>B-69743840313604</basicUdiDi>
    <tradeName>COVID-19 /Flu A&amp;B /RSV /ADENO Ag Combo Rapid Test Cassette (Swab)</tradeName>
    <deviceName>COVID-19 /Flu A&amp;B /RSV /ADENO Ag Combo Rapid Test Cassette (Swab)</deviceName>
    <manufacturerName>Zhejiang Anji Saianfu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045029</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3022501</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:13:32.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>69743840313536</udiDi>
    <basicUdiDi>B-69743840313536</basicUdiDi>
    <tradeName>COVID-19 /Flu A&amp;B /RSV Ag Combo Rapid Test Cassette (Swab)</tradeName>
    <deviceName>COVID-19 /Flu A&amp;B /RSV Ag Combo Rapid Test Cassette (Swab)</deviceName>
    <manufacturerName>Zhejiang Anji Saianfu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045029</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3022401</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:13:31.080Z</lastUpdated>
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