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    <tradeName>CerTest Entamoeba</tradeName>
    <deviceName>CerTest Entamoeba</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EH820001V</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:19:31.263Z</lastUpdated>
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    <udiDi>08435440203643</udiDi>
    <basicUdiDi>84354402_MDXVECTOR_CHIHM</basicUdiDi>
    <tradeName>VIASURE Chikungunya Virus Real Time PCR Detection Kit</tradeName>
    <deviceName>VIASURE Chikungunya Virus Real Time PCR Detection Kit</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040525</emdnCode>
    <emdnDescription>CHIKUNGUNYA VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:19:30.265Z</lastUpdated>
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    <udiDi>08435440200482</udiDi>
    <basicUdiDi>84354402IDXGASTROB_CA5W</basicUdiDi>
    <tradeName>CerTest Campylobacter</tradeName>
    <deviceName>CerTest Campylobacter</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
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    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA820001V</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:19:27.267Z</lastUpdated>
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    <udiDi>08435440200666</udiDi>
    <basicUdiDi>84354402IDXGASTROB_K4D</basicUdiDi>
    <tradeName>CerTest Crypto</tradeName>
    <deviceName>CerTest Crypto</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K820001V</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:19:25.755Z</lastUpdated>
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    <udiDi>08435440200376</udiDi>
    <basicUdiDi>84354402IDXGASTROB_GX7Q</basicUdiDi>
    <tradeName>CerTest C. difficile GDH+Toxin A+B</tradeName>
    <deviceName>CerTest C. difficile GDH+Toxin A+B</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090106</emdnCode>
    <emdnDescription>CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GX872001V</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:19:12.044Z</lastUpdated>
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    <udiDi>08435440200369</udiDi>
    <basicUdiDi>84354402IDXGASTROB_CD64</basicUdiDi>
    <tradeName>CerTest Clostridium difficile Toxin A+B</tradeName>
    <deviceName>CerTest Clostridium difficile Toxin A+B</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090106</emdnCode>
    <emdnDescription>CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CD882001V</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:19:10.457Z</lastUpdated>
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    <udiDi>08435440200345</udiDi>
    <basicUdiDi>84354402IDXGASTROB_GD6G</basicUdiDi>
    <tradeName>CerTest Clostridium difficile antigen GDH</tradeName>
    <deviceName>CerTest Clostridium difficile antigen GDH</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090106</emdnCode>
    <emdnDescription>CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GD820001V</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:19:08.238Z</lastUpdated>
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    <udiDi>08435440200314</udiDi>
    <basicUdiDi>84354402IDXGASTROB_P4P</basicUdiDi>
    <tradeName>CerTest H. pylori</tradeName>
    <deviceName>CerTest H. pylori</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P820001V</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:19:06.554Z</lastUpdated>
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    <udiDi>08435440200277</udiDi>
    <basicUdiDi>84354402IDXGASTROB_RG7P</basicUdiDi>
    <tradeName>CerTest Rota+Adeno+Astro+Noro</tradeName>
    <deviceName>CerTest Rota+Adeno+Astro+Noro</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RG862001V</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:19:05.799Z</lastUpdated>
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    <udiDi>08435440200260</udiDi>
    <basicUdiDi>84354402IDXGASTROB_RA7B</basicUdiDi>
    <tradeName>CerTest ROTA+ADENO+NORO</tradeName>
    <deviceName>CerTest ROTA+ADENO+NORO</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
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    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RA872001V</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:19:04.276Z</lastUpdated>
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    <udiDi>08435440200253</udiDi>
    <basicUdiDi>84354402IDXGASTROB_RN85</basicUdiDi>
    <tradeName>CerTest Rotavirus+Norovirus GI/GII</tradeName>
    <deviceName>CerTest Rotavirus+Norovirus GI/GII</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RN882001V</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:19:01.432Z</lastUpdated>
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    <udiDi>08435440200246</udiDi>
    <basicUdiDi>84354402IDXGASTROB_NV89</basicUdiDi>
    <tradeName>CerTest Norovirus GI+GII</tradeName>
    <deviceName>CerTest Norovirus GI+GII</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NV882001V</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:18:59.819Z</lastUpdated>
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    <udiDi>08435440200208</udiDi>
    <basicUdiDi>84354402IDXGASTROB_AT6W</basicUdiDi>
    <tradeName>CerTest Astrovirus</tradeName>
    <deviceName>CerTest Astrovirus</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AT820001V</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:18:59.162Z</lastUpdated>
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    <udiDi>08435440200185</udiDi>
    <basicUdiDi>84354402IDXGASTROB_XR8X</basicUdiDi>
    <tradeName>CerTest Rotavirus+Adenovirus</tradeName>
    <deviceName>CerTest Rotavirus+Adenovirus</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XR882001V</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:18:57.459Z</lastUpdated>
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    <udiDi>08435440200161</udiDi>
    <basicUdiDi>84354402IDXGASTROB_AD5W</basicUdiDi>
    <tradeName>CerTest Adenovirus</tradeName>
    <deviceName>CerTest Adenovirus</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
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    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD820001V</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:18:55.101Z</lastUpdated>
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    <tradeName>CerTest Rotavirus</tradeName>
    <deviceName>CerTest Rotavirus</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
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    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R820001V</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:18:53.584Z</lastUpdated>
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    <basicUdiDi>84354402IDXGASTROB_AD5W</basicUdiDi>
    <tradeName>CerTest Adenovirus</tradeName>
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    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
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    <tradeName>CerTest Adenovirus</tradeName>
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    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
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    <tradeName>VIASURE Flu Typing II Real Time PCR Detection Kit</tradeName>
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    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>W0105040504</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-HXN196T</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:49:24.139Z</lastUpdated>
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    <tradeName>VIASURE Flu Typing II Real Time PCR Detection Kit</tradeName>
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    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
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    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-HXN101H</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:49:23.902Z</lastUpdated>
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