<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-A066DD</udiDi>
    <basicUdiDi>B-A066DD</basicUdiDi>
    <tradeName>D-A066DD</tradeName>
    <deviceName>INDICAID™ Chikungunya 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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INDICAID™ Chikungunya Rapid Antigen Test</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:43:20.179Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A056DA</udiDi>
    <basicUdiDi>B-A056DA</basicUdiDi>
    <tradeName>D-A056DA</tradeName>
    <deviceName>INDICAID™ Helicobacter pylori Rapid IgG Antibody 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>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INDICAID™ Helicobacter pylori Rapid IgG Antibody Test</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:43:02.120Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A055D8</udiDi>
    <basicUdiDi>B-A055D8</basicUdiDi>
    <tradeName>D-A055D8</tradeName>
    <deviceName>INDICAID™ Helicobacter pylori 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>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INDICAID™ Helicobacter pylori Rapid Antigen Test</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:43:00.589Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A043CZ</udiDi>
    <basicUdiDi>B-A043CZ</basicUdiDi>
    <tradeName>D-A043CZ</tradeName>
    <deviceName>INDICAID™ Ureaplasma Urealyticum Rapid Antibody 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>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INDICAID™ Ureaplasma Urealyticum Rapid Antibody Test</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:42:45.506Z</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>84365942147902</udiDi>
    <basicUdiDi>B-84365942147902</basicUdiDi>
    <tradeName>biotical Campylobacter Card (+PC +NC)</tradeName>
    <deviceName>biotical Campylobacter Card (+PC +NC)</deviceName>
    <manufacturerName>BIOTICAL HEALTH S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000018831</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTB25CACN</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:34:49.382Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697994388Ir0593VFD</udiDi>
    <basicUdiDi>B-697994388Ir0593VFD</basicUdiDi>
    <tradeName>D-697994388Ir0593VFD</tradeName>
    <deviceName>HSV Herpes Simplex Virus Ab Test Kit</deviceName>
    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000053775</manufacturerSrn>
    <authorisedRepresentativeName>Crealkraft GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000049943</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099001</emdnCode>
    <emdnDescription>CMV - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ir059</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:24:55.633Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697994388Ir0503BCQ</udiDi>
    <basicUdiDi>B-697994388Ir0503BCQ</basicUdiDi>
    <tradeName>D-697994388Ir0503BCQ</tradeName>
    <deviceName>Bordetella Pertussis (BP) Antigen Detection Kit</deviceName>
    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000053775</manufacturerSrn>
    <authorisedRepresentativeName>Crealkraft GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000049943</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ir050</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:24:44.338Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697994388Ir0493SEY</udiDi>
    <basicUdiDi>B-697994388Ir0493SEY</basicUdiDi>
    <tradeName>D-697994388Ir0493SEY</tradeName>
    <deviceName>COVID-19 (2019n-Cov) Antigen Detection Kit</deviceName>
    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000053775</manufacturerSrn>
    <authorisedRepresentativeName>Crealkraft GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000049943</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099001</emdnCode>
    <emdnDescription>CMV - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ir049</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:24:43.095Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697994388Ir0473NEC</udiDi>
    <basicUdiDi>B-697994388Ir0473NEC</basicUdiDi>
    <tradeName>D-697994388Ir0473NEC</tradeName>
    <deviceName>Mycoplasma Pneumoniae Ab Test Kit</deviceName>
    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000053775</manufacturerSrn>
    <authorisedRepresentativeName>Crealkraft GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000049943</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090101</emdnCode>
    <emdnDescription>CHLAMYDIA AG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ir047</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:24:41.721Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697994388Ir0463LE3</udiDi>
    <basicUdiDi>B-697994388Ir0463LE3</basicUdiDi>
    <tradeName>D-697994388Ir0463LE3</tradeName>
    <deviceName>Influ A+B/ADV/RSV Ag 4-in-1 Test Panel</deviceName>
    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000053775</manufacturerSrn>
    <authorisedRepresentativeName>Crealkraft GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000049943</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090601</emdnCode>
    <emdnDescription>CORONAVIRUS / INFLUENZA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ir046</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:24:34.727Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697994388Ir0453JDS</udiDi>
    <basicUdiDi>B-697994388Ir0453JDS</basicUdiDi>
    <tradeName>D-697994388Ir0453JDS</tradeName>
    <deviceName>RSV Respiratory Syncytial Virus Ag Test Kit</deviceName>
    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000053775</manufacturerSrn>
    <authorisedRepresentativeName>Crealkraft GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000049943</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099002</emdnCode>
    <emdnDescription>RSV - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ir045</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:24:33.987Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697994388Ir0443GDF</udiDi>
    <basicUdiDi>B-697994388Ir0443GDF</basicUdiDi>
    <tradeName>D-697994388Ir0443GDF</tradeName>
    <deviceName>Strep A Ag Test Kit</deviceName>
    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000053775</manufacturerSrn>
    <authorisedRepresentativeName>Crealkraft GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000049943</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ir044</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:24:32.676Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697994388Ir0433ED6</udiDi>
    <basicUdiDi>B-697994388Ir0433ED6</basicUdiDi>
    <tradeName>D-697994388Ir0433ED6</tradeName>
    <deviceName>Influenza A+B Ag Test Kit</deviceName>
    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000053775</manufacturerSrn>
    <authorisedRepresentativeName>Crealkraft GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000049943</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ir043</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:24:31.738Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697994388Ir04038BX</udiDi>
    <basicUdiDi>B-697994388Ir04038BX</basicUdiDi>
    <tradeName>D-697994388Ir04038BX</tradeName>
    <deviceName>Norovirus GI/GII Antigen Detection Kit</deviceName>
    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000053775</manufacturerSrn>
    <authorisedRepresentativeName>Crealkraft GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000049943</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099003</emdnCode>
    <emdnDescription>MONONUCLEOSIS (EBV) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ir040</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:24:24.277Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697994388Ir0423CCV</udiDi>
    <basicUdiDi>B-697994388Ir0423CCV</basicUdiDi>
    <tradeName>D-697994388Ir0423CCV</tradeName>
    <deviceName>Clostridium Difficile Related Test Kit</deviceName>
    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000053775</manufacturerSrn>
    <authorisedRepresentativeName>Crealkraft GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000049943</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090106</emdnCode>
    <emdnDescription>CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ir042</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:24:22.993Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697994388Ir0363HDL</udiDi>
    <basicUdiDi>B-697994388Ir0363HDL</basicUdiDi>
    <tradeName>D-697994388Ir0363HDL</tradeName>
    <deviceName>Salmonella Typhi Ag Test Kit</deviceName>
    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000053775</manufacturerSrn>
    <authorisedRepresentativeName>Crealkraft GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000049943</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ir036</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:24:05.382Z</lastUpdated>
  </row>
</eudamedExport>