<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-SCSTP-DC9</udiDi>
    <basicUdiDi>B-SCSTP-DC9</basicUdiDi>
    <tradeName>Salmonella typhi and paratyphi Antigen Control</tradeName>
    <deviceName>Salmonella typhi and paratyphi Antigen Control</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>W0105094001</emdnCode>
    <emdnDescription>CONTROLS INFECTIOUS IMMUNOLOGY - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCSTP-D</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-23T03:51:08.140Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SCZIBG-DY8</udiDi>
    <basicUdiDi>B-SCZIBG-DY8</basicUdiDi>
    <tradeName>ZIKA IgG Control</tradeName>
    <deviceName>ZIKA IgG Control</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>W0105094001</emdnCode>
    <emdnDescription>CONTROLS INFECTIOUS IMMUNOLOGY - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCZIBG-D</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:40:35.081Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCHP-PN2HG9F</udiDi>
    <basicUdiDi>B-GCHP-PN2HG9F</basicUdiDi>
    <tradeName>H. pylori Ag Control Kit</tradeName>
    <deviceName>H. pylori Ag Control Kit</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>W0105094001</emdnCode>
    <emdnDescription>CONTROLS INFECTIOUS IMMUNOLOGY - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCHP-PN2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:28:19.780Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCOV-PNN4</udiDi>
    <basicUdiDi>B-GCCOV-PNN4</basicUdiDi>
    <tradeName>COVID-19 IgG/IgM CONTROL Kit</tradeName>
    <deviceName>COVID-19 IgG/IgM CONTROL Kit</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>W0105094001</emdnCode>
    <emdnDescription>CONTROLS INFECTIOUS IMMUNOLOGY - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCOV-PN10，GCCOV-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:25:25.814Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCOV-PN20HGJA</udiDi>
    <basicUdiDi>B-GCCOV-PN20HGJA</basicUdiDi>
    <tradeName>COVID-19 IgG/IgM CONTROL Kit</tradeName>
    <deviceName>COVID-19 IgG/IgM CONTROL Kit</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105094001</emdnCode>
    <emdnDescription>CONTROLS INFECTIOUS IMMUNOLOGY - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCOV-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:25:23.128Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCOV-PN10HGJ3</udiDi>
    <basicUdiDi>B-GCCOV-PN10HGJ3</basicUdiDi>
    <tradeName>COVID-19 IgG/IgM CONTROL Kit</tradeName>
    <deviceName>COVID-19 IgG/IgM CONTROL Kit</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105094001</emdnCode>
    <emdnDescription>CONTROLS INFECTIOUS IMMUNOLOGY - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCOV-PN10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:25:22.325Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCOV(Ag)-PNF6</udiDi>
    <basicUdiDi>B-GCCOV(Ag)-PNF6</basicUdiDi>
    <tradeName>COVID-19 Antigen Control Kit</tradeName>
    <deviceName>COVID-19 Antigen Control Kit</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105094001</emdnCode>
    <emdnDescription>CONTROLS INFECTIOUS IMMUNOLOGY - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCOV(Ag)-PN10，GCCOV(Ag)-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:23:44.372Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCOV(Ag)-PN20HG4Y</udiDi>
    <basicUdiDi>B-GCCOV(Ag)-PN20HG4Y</basicUdiDi>
    <tradeName>COVID-19 Antigen Control Kit</tradeName>
    <deviceName>COVID-19 Antigen Control Kit</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105094001</emdnCode>
    <emdnDescription>CONTROLS INFECTIOUS IMMUNOLOGY - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCOV(Ag)-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:23:43.576Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCOV(Ag)-PN10HG4R</udiDi>
    <basicUdiDi>B-GCCOV(Ag)-PN10HG4R</basicUdiDi>
    <tradeName>COVID-19 Antigen Control Kit</tradeName>
    <deviceName>COVID-19 Antigen Control Kit</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105094001</emdnCode>
    <emdnDescription>CONTROLS INFECTIOUS IMMUNOLOGY - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCOV(Ag)-PN10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:23:42.777Z</lastUpdated>
  </row>
  <row>
    <udiDi>84365942157598</udiDi>
    <basicUdiDi>B-84365942157598</basicUdiDi>
    <tradeName>biotical E. Coli Positive control (1u)</tradeName>
    <deviceName>biotical E. Coli Positive control (1u)</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>W0105094001</emdnCode>
    <emdnDescription>CONTROLS INFECTIOUS IMMUNOLOGY - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CPRT01E</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:13:08.100Z</lastUpdated>
  </row>
  <row>
    <udiDi>84365942153224</udiDi>
    <basicUdiDi>B-84365942153224</basicUdiDi>
    <tradeName>biotical Crypto Positive control (30u)</tradeName>
    <deviceName>biotical Crypto Positive control (30u)</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>W0105094001</emdnCode>
    <emdnDescription>CONTROLS INFECTIOUS IMMUNOLOGY - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CPRT30K</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:13:04.093Z</lastUpdated>
  </row>
  <row>
    <udiDi>84365942152852</udiDi>
    <basicUdiDi>B-84365942152852</basicUdiDi>
    <tradeName>1 control positivo Giardia (sin test rápido)</tradeName>
    <deviceName>biotical Giardia Positive control (1u)</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>W0105094001</emdnCode>
    <emdnDescription>CONTROLS INFECTIOUS IMMUNOLOGY - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CPRT01G</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:12:57.690Z</lastUpdated>
  </row>
  <row>
    <udiDi>84365942152784</udiDi>
    <basicUdiDi>B-84365942152784</basicUdiDi>
    <tradeName>biotical Giardia Positive control (30u)</tradeName>
    <deviceName>biotical Giardia Positive control (30u)</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>W0105094001</emdnCode>
    <emdnDescription>CONTROLS INFECTIOUS IMMUNOLOGY - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CPRT30G</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:12:56.895Z</lastUpdated>
  </row>
  <row>
    <udiDi>84365942152234</udiDi>
    <basicUdiDi>B-84365942152234</basicUdiDi>
    <tradeName>biotical Y. enterocolitica O:3 Positive control (30u)</tradeName>
    <deviceName>biotical Y. enterocolitica O:3 Positive control (30u)</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>W0105094001</emdnCode>
    <emdnDescription>CONTROLS INFECTIOUS IMMUNOLOGY - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CPRT30Y3</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:12:51.316Z</lastUpdated>
  </row>
  <row>
    <udiDi>84365942152302</udiDi>
    <basicUdiDi>B-84365942152302</basicUdiDi>
    <tradeName>biotical Y. enterocolitica O:3 Positive control (1u)</tradeName>
    <deviceName>biotical Y. enterocolitica O:3 Positive control (1u)</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>W0105094001</emdnCode>
    <emdnDescription>CONTROLS INFECTIOUS IMMUNOLOGY - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CPRT01Y3</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:12:49.007Z</lastUpdated>
  </row>
  <row>
    <udiDi>84365942151862</udiDi>
    <basicUdiDi>B-84365942151862</basicUdiDi>
    <tradeName>1 control positivo Yersinia enterocolitica O:9 (sin test rápido)</tradeName>
    <deviceName>biotical Y. enterocolitica O:9 Positive control (1u)</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>W0105094001</emdnCode>
    <emdnDescription>CONTROLS INFECTIOUS IMMUNOLOGY - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CPRT01Y9</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:12:30.411Z</lastUpdated>
  </row>
  <row>
    <udiDi>84365942151794</udiDi>
    <basicUdiDi>B-84365942151794</basicUdiDi>
    <tradeName>biotical Y. enterocolitica O:9 Positive control (30u)</tradeName>
    <deviceName>biotical Y. enterocolitica O:9 Positive control (30u)</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>W0105094001</emdnCode>
    <emdnDescription>CONTROLS INFECTIOUS IMMUNOLOGY - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CPRT30Y9</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:12:29.611Z</lastUpdated>
  </row>
  <row>
    <udiDi>84365942151312</udiDi>
    <basicUdiDi>B-84365942151312</basicUdiDi>
    <tradeName>biotical C. difficile Toxin B Positive control (1u)</tradeName>
    <deviceName>biotical C. difficile Toxin B Positive control (1u)</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>W0105094001</emdnCode>
    <emdnDescription>CONTROLS INFECTIOUS IMMUNOLOGY - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CPRT01TB</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:12:24.878Z</lastUpdated>
  </row>
  <row>
    <udiDi>84365942151244</udiDi>
    <basicUdiDi>B-84365942151244</basicUdiDi>
    <tradeName>biotical C. difficile Toxin B Positive control (30u)</tradeName>
    <deviceName>biotical C. difficile Toxin B Positive control (30u)</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>W0105094001</emdnCode>
    <emdnDescription>CONTROLS INFECTIOUS IMMUNOLOGY - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CPRT30TB</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:12:19.661Z</lastUpdated>
  </row>
  <row>
    <udiDi>84365942151176</udiDi>
    <basicUdiDi>B-84365942151176</basicUdiDi>
    <tradeName>biotical C. difficile Toxin A Positive control (1u)</tradeName>
    <deviceName>biotical C. difficile Toxin A Positive control (1u)</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>W0105094001</emdnCode>
    <emdnDescription>CONTROLS INFECTIOUS IMMUNOLOGY - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CPRT01TA</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:12:18.404Z</lastUpdated>
  </row>
</eudamedExport>