<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-MAANA-LC4138</udiDi>
    <basicUdiDi>B-MAANA-LC4138</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MAANA-LC41</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T01:01:51.299Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MADNA-LC414Z</udiDi>
    <basicUdiDi>B-MADNA-LC414Z</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MADNA-LC41</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T01:01:51.281Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MARF-LC41AR</udiDi>
    <basicUdiDi>B-MARF-LC41AR</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MARF-LC41</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T01:01:51.262Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MACCP-LC414N</udiDi>
    <basicUdiDi>B-MACCP-LC414N</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MACCP-LC41</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T01:01:51.238Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MAIGE-LC415V</udiDi>
    <basicUdiDi>B-MAIGE-LC415V</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MAIGE-LC41</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T01:01:51.206Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MIDEN-LC42BB</udiDi>
    <basicUdiDi>B-MIDEN-LC42BB</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MIDEN-LC42</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T01:01:51.174Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MIDEG-LC418E</udiDi>
    <basicUdiDi>B-MIDEG-LC418E</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MIDEG-LC41</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T01:01:51.154Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MIHPG-LC31GJ</udiDi>
    <basicUdiDi>B-MIHPG-LC31GJ</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MIHPG-LC31</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T01:01:51.110Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MNMG-LC41G8</udiDi>
    <basicUdiDi>B-MNMG-LC41G8</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MNMG-LC41</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T01:01:51.080Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MSFEN-LC41KM</udiDi>
    <basicUdiDi>B-MSFEN-LC41KM</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSFEN-LC41</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T01:01:51.051Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MSTAU-LC42UQ</udiDi>
    <basicUdiDi>B-MSTAU-LC42UQ</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSTAU-LC42</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T01:01:51.032Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MSADA-LC42AW</udiDi>
    <basicUdiDi>B-MSADA-LC42AW</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSADA-LC42</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T01:01:51.003Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ICFRAN-MC85AZ</udiDi>
    <basicUdiDi>B-ICFRAN-MC85AZ</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICFRAN-MC85</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T01:01:50.986Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ICFGN-MC836A</udiDi>
    <basicUdiDi>B-ICFGN-MC836A</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICFGN-MC83</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T01:01:50.952Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SVD-C4243</udiDi>
    <basicUdiDi>B-SVD-C4243</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SVD-C42</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T01:01:50.913Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934078051289</udiDi>
    <basicUdiDi>69340780STA81A01WM</basicUdiDi>
    <tradeName>RightSign Home+</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISTA-C81H001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:18:39.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934078006104</udiDi>
    <basicUdiDi>69340780STA81A00WK</basicUdiDi>
    <tradeName>RightSign</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISTA-C81P001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:17:58.403Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934078025013</udiDi>
    <basicUdiDi>B-06934078025013</basicUdiDi>
    <tradeName>Diagpal</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RDP-700</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T21:45:55.894Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934078015007</udiDi>
    <basicUdiDi>69340780SFOB01A007P</basicUdiDi>
    <tradeName>Proline</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SFOB-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:25:34.670Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ICTG-C41HP</udiDi>
    <basicUdiDi>B-ICTG-C41HP</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Cryptococcus Antigen Rapid Test Cassette(Whole Blood/Serum/Plasma )</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060303</emdnCode>
    <emdnDescription>CRYPTOCOCCUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICTG-C41</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:03:50.316Z</lastUpdated>
  </row>
</eudamedExport>