<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-ICRG-402ED</udiDi>
    <basicUdiDi>B-ICRG-402ED</basicUdiDi>
    <tradeName>Cryptococcus Antigen Rapid Test Cassette</tradeName>
    <deviceName>Cryptococcus Antigen 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>W0105060303</emdnCode>
    <emdnDescription>CRYPTOCOCCUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICRG-402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-27T03:36:47.886Z</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>
  <row>
    <udiDi>D-ICRG-R4028A</udiDi>
    <basicUdiDi>B-ICRG-R4028A</basicUdiDi>
    <tradeName>Cryptococcus Antigen Rapid Test Cassette</tradeName>
    <deviceName>Cryptococcus Antigen Rapid Test Cassette</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>W0105060303</emdnCode>
    <emdnDescription>CRYPTOCOCCUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICRG-R402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:05:13.795Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCr(Ag)-402aRU</udiDi>
    <basicUdiDi>B-GCCr(Ag)-402aRU</basicUdiDi>
    <tradeName>Cryptococcal Ag Rapid Test Cassette (Whole Blood/Serum/Plasma/Cerebral Spinal Fluid)</tradeName>
    <deviceName>Cryptococcal Ag Rapid Test Cassette (Whole Blood/Serum/Plasma/Cerebral Spinal Fluid)</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>W0105060303</emdnCode>
    <emdnDescription>CRYPTOCOCCUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCr(Ag)-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:25:31.988Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCr(Ag)-402aHGDP</udiDi>
    <basicUdiDi>B-GCCr(Ag)-402aHGDP</basicUdiDi>
    <tradeName>Cryptococcal Ag Rapid Test Cassette (Whole Blood/Serum/Plasma/Cerebral Spinal Fluid)</tradeName>
    <deviceName>Cryptococcal Ag Rapid Test Cassette (Whole Blood/Serum/Plasma/Cerebral Spinal Fluid)</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>W0105060303</emdnCode>
    <emdnDescription>CRYPTOCOCCUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCr(Ag)-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:25:30.328Z</lastUpdated>
  </row>
  <row>
    <udiDi>15065023763778</udiDi>
    <basicUdiDi>B-15065023763778</basicUdiDi>
    <tradeName>TruVue</tradeName>
    <deviceName>Cryptococcal Antigen Assay (FIA)</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060303</emdnCode>
    <emdnDescription>CRYPTOCOCCUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TV20039</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:36:28.339Z</lastUpdated>
  </row>
  <row>
    <udiDi>15065023763341</udiDi>
    <basicUdiDi>B-15065023763341</basicUdiDi>
    <tradeName>TruVue</tradeName>
    <deviceName>Cryptococcal Antigen Lateral Flow Assay (LFA)</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060303</emdnCode>
    <emdnDescription>CRYPTOCOCCUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TV10035</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:35:01.043Z</lastUpdated>
  </row>
  <row>
    <udiDi>08964004385001</udiDi>
    <basicUdiDi>B-08964004385001</basicUdiDi>
    <tradeName>R-test Cryptococcus Capsular Polysaccharide Rapid Test</tradeName>
    <deviceName>R-test Cryptococcus Capsular Polysaccharide Rapid Test</deviceName>
    <manufacturerName>Lab Diagnostic Systems (SMC) Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>PK-MF-000046055</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060303</emdnCode>
    <emdnDescription>CRYPTOCOCCUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R-39050</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:29:43.038Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640146270184</udiDi>
    <basicUdiDi>B-07640146270184</basicUdiDi>
    <tradeName>07640146270184</tradeName>
    <deviceName>TECO® Fast Cryptococcus neoformans Ag Lateral Flow Assay</deviceName>
    <manufacturerName>TECOmedical AG</manufacturerName>
    <manufacturerSrn>CH-MF-000030341</manufacturerSrn>
    <authorisedRepresentativeName>EUROBIO SCIENTIFIC</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000023178</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060303</emdnCode>
    <emdnDescription>CRYPTOCOCCUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TE1085</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:58:21.802Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975344570127</udiDi>
    <basicUdiDi>B-06975344570127</basicUdiDi>
    <tradeName>Cryptococcal Antigen Rapid Test Strip</tradeName>
    <deviceName>Cryptococcal Antigen Rapid Test Strip</deviceName>
    <manufacturerName>Tianjin Jianbo Biological Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040307</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060303</emdnCode>
    <emdnDescription>CRYPTOCOCCUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C6002</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:28:51.339Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975344570103</udiDi>
    <basicUdiDi>B-06975344570103</basicUdiDi>
    <tradeName>Cryptococcal Antigen Rapid Test Cassette</tradeName>
    <deviceName>Cryptococcal Antigen Rapid Test Cassette</deviceName>
    <manufacturerName>Tianjin Jianbo Biological Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040307</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060303</emdnCode>
    <emdnDescription>CRYPTOCOCCUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C6004</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:28:49.745Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973181850334</udiDi>
    <basicUdiDi>B-06973181850334</basicUdiDi>
    <tradeName>StrongStep® Cryptococcal Antigen Rapid Test</tradeName>
    <deviceName>Cryptococcal Antigen Rapid Test</deviceName>
    <manufacturerName>Nanjing Liming Bio-products Co. Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041298</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060303</emdnCode>
    <emdnDescription>CRYPTOCOCCUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>502080</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:52:13.312Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532679917565</udiDi>
    <basicUdiDi>353267F00074P8G</basicUdiDi>
    <tradeName>BIOSYNEX CryptoPS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105060303</emdnCode>
    <emdnDescription>CRYPTOCOCCUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1120001-50</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:27:07.529Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970514080673</udiDi>
    <basicUdiDi>B-06970514080673</basicUdiDi>
    <tradeName>06970514080673</tradeName>
    <deviceName>Cryptococcal Capsular Polysaccharide Detection Kit (CLIA)</deviceName>
    <manufacturerName>Genobio Pharmaceutical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027997</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060303</emdnCode>
    <emdnDescription>CRYPTOCOCCUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GXMCLIA-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:07:12.057Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970514080543</udiDi>
    <basicUdiDi>B-06970514080543</basicUdiDi>
    <tradeName>Cryptococcal Capsular Polysaccharide Detection K-Set (Lateral Flow Assay)</tradeName>
    <deviceName>Cryptococcal Capsular Polysaccharide Detection K-Set (Lateral Flow Assay)</deviceName>
    <manufacturerName>Genobio Pharmaceutical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027997</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060303</emdnCode>
    <emdnDescription>CRYPTOCOCCUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GXM-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:06:52.854Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970514080536</udiDi>
    <basicUdiDi>B-06970514080536</basicUdiDi>
    <tradeName>Cryptococcal Capsular Polysaccharide Detection K-Set (Lateral Flow Assay)</tradeName>
    <deviceName>Cryptococcal Capsular Polysaccharide Detection K-Set (Lateral Flow Assay)</deviceName>
    <manufacturerName>Genobio Pharmaceutical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027997</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060303</emdnCode>
    <emdnDescription>CRYPTOCOCCUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GXM-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:06:49.252Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700531700680</udiDi>
    <basicUdiDi>353267F00074P8G</basicUdiDi>
    <tradeName>BIOSYNEX CryptoPS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105060303</emdnCode>
    <emdnDescription>CRYPTOCOCCUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1120001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T00:34:52.741Z</lastUpdated>
  </row>
</eudamedExport>