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<eudamedExport entity="devices">
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    <basicUdiDi>697072581D2SRF25M32P15CT3</basicUdiDi>
    <tradeName>06970725815392</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atlas Link Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021058</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</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>C2134-CR-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T03:21:14.930Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970725815408</udiDi>
    <basicUdiDi>697072581D2SRF25M32P15CT3</basicUdiDi>
    <tradeName>06970725815408</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atlas Link Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021058</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</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>C2134-CR-03</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T03:21:14.895Z</lastUpdated>
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    <udiDi>06970725815415</udiDi>
    <basicUdiDi>697072581D2SRF25M32P15CT3</basicUdiDi>
    <tradeName>06970725815415</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atlas Link Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021058</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</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>C2134-CR-04</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T03:21:14.858Z</lastUpdated>
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    <udiDi>06970725815422</udiDi>
    <basicUdiDi>697072581D2SRF25M32P15CT3</basicUdiDi>
    <tradeName>06970725815422</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atlas Link Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021058</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</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>C2134-CF-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T03:21:14.823Z</lastUpdated>
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  <row>
    <udiDi>06970725815439</udiDi>
    <basicUdiDi>697072581D2SRF25M32P15CT3</basicUdiDi>
    <tradeName>06970725815439</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atlas Link Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021058</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</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>C2134-CF-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T03:21:14.772Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970725815446</udiDi>
    <basicUdiDi>697072581D2SRF25M32P15CT3</basicUdiDi>
    <tradeName>06970725815446</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atlas Link Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021058</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</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>C2134-CF-03</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T03:21:14.720Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970725815453</udiDi>
    <basicUdiDi>697072581D2SRF25M32P15CT3</basicUdiDi>
    <tradeName>06970725815453</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atlas Link Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021058</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</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>C2134-CF-04</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T03:21:14.694Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970725815460</udiDi>
    <basicUdiDi>697072581D2SRF25M32P15CT3</basicUdiDi>
    <tradeName>06970725815460</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atlas Link Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021058</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</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>C2134-RF-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T03:21:14.655Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970725815477</udiDi>
    <basicUdiDi>697072581D2SRF25M32P15CT3</basicUdiDi>
    <tradeName>06970725815477</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atlas Link Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021058</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</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>C2134-RF-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T03:21:14.614Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970725815484</udiDi>
    <basicUdiDi>697072581D2SRF25M32P15CT3</basicUdiDi>
    <tradeName>06970725815484</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atlas Link Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021058</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</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>C2134-RF-03</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T03:21:14.586Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970725815491</udiDi>
    <basicUdiDi>697072581D2SRF25M32P15CT3</basicUdiDi>
    <tradeName>06970725815491</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atlas Link Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021058</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</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>C2134-RF-04</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T03:21:14.532Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MUR-24E3W</udiDi>
    <basicUdiDi>B-MUR-24E3W</basicUdiDi>
    <tradeName>D-MUR-24E3W</tradeName>
    <deviceName>Respiratory Pathogens Multiplex Detection Kit</deviceName>
    <manufacturerName>Hysen Biotech.Inc</manufacturerName>
    <manufacturerSrn>KR-MF-000048224</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>MUR-24E</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:09:50.802Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MME-14ETX</udiDi>
    <basicUdiDi>B-MME-14ETX</basicUdiDi>
    <tradeName>D-MME-14ETX</tradeName>
    <deviceName>Meningitis/Encephalitis (ME) Pathogens Multiplex Detection Kit</deviceName>
    <manufacturerName>Hysen Biotech.Inc</manufacturerName>
    <manufacturerSrn>KR-MF-000048224</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070505</emdnCode>
    <emdnDescription>MENINGITIS / ENCEPHALITIS INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MME-14E</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:09:48.263Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MLR-19EYG</udiDi>
    <basicUdiDi>B-MLR-19EYG</basicUdiDi>
    <tradeName>D-MLR-19EYG</tradeName>
    <deviceName>Lower Respiratory Pathogens Multiplex Detection Kit</deviceName>
    <manufacturerName>Hysen Biotech.Inc</manufacturerName>
    <manufacturerSrn>KR-MF-000048224</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>MLR-19E</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:09:47.018Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-INRC-625KJ</udiDi>
    <basicUdiDi>B-INRC-625KJ</basicUdiDi>
    <tradeName>Norovirus and Rotavirus Combo Rapid Test</tradeName>
    <deviceName>Norovirus and Rotavirus Combo Rapid Test</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>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INRC-625</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:03:52.704Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DBP01UK</udiDi>
    <basicUdiDi>B-DBP01UK</basicUdiDi>
    <tradeName>D-DBP01UK</tradeName>
    <deviceName>Blood Pathogens and Drug Resistance Genes Digital PCR Detection Kit</deviceName>
    <manufacturerName>Hysen Biotech.Inc</manufacturerName>
    <manufacturerSrn>KR-MF-000048224</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070502</emdnCode>
    <emdnDescription>OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DBP01</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:58:46.013Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697603130CSTIZK01AR77C</udiDi>
    <basicUdiDi>B-697603130CSTIZK01AR77C</basicUdiDi>
    <tradeName>D-697603130CSTIZK01AR77C</tradeName>
    <deviceName>GeneStream STI Controls</deviceName>
    <manufacturerName>Hangzhou Danwei Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041344</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070501</emdnCode>
    <emdnDescription>STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CSTIZK01A-AHG4E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:18:25.475Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697603130CRTI701AWBSW</udiDi>
    <basicUdiDi>B-697603130CRTI701AWBSW</basicUdiDi>
    <tradeName>D-697603130CRTI701AWBSW</tradeName>
    <deviceName>GeneStream RTI-7 Assay</deviceName>
    <manufacturerName>Hangzhou Danwei Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041344</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070502</emdnCode>
    <emdnDescription>OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CRTI701A-AHG4E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:18:19.387Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697603130CRTI601AW4RP</udiDi>
    <basicUdiDi>B-697603130CRTI601AW4RP</basicUdiDi>
    <tradeName>D-697603130CRTI601AW4RP</tradeName>
    <deviceName>GeneStream SARS-CoV-2/FluA/FluB/RSV/AdV/RhV Assay</deviceName>
    <manufacturerName>Hangzhou Danwei Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041344</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070502</emdnCode>
    <emdnDescription>OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CRTI601A-AHG4E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:18:18.323Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697603130CGCT01AD5VC</udiDi>
    <basicUdiDi>B-697603130CGCT01AD5VC</basicUdiDi>
    <tradeName>D-697603130CGCT01AD5VC</tradeName>
    <deviceName>GeneStream GV/CV/TV Assay</deviceName>
    <manufacturerName>Hangzhou Danwei Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041344</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070501</emdnCode>
    <emdnDescription>STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CGCT01A-AHG4E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:18:08.167Z</lastUpdated>
  </row>
</eudamedExport>