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<eudamedExport entity="devices">
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    <udiDi>06976753477540</udiDi>
    <basicUdiDi>B-06976753477540</basicUdiDi>
    <tradeName>Serum Amyloid A (SAA) Assay Reagent Kit (CMIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C2KC002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:01:18.849Z</lastUpdated>
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    <udiDi>06976753474600</udiDi>
    <basicUdiDi>B-06976753474600</basicUdiDi>
    <tradeName>Malaria P.fP.v Rapid Test Device (whole blood)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A290901D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:59:10.602Z</lastUpdated>
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  <row>
    <udiDi>06976753474570</udiDi>
    <basicUdiDi>B-06976753474570</basicUdiDi>
    <tradeName>Malaria P.f.Pan Antigen Rapid Test Device (whole blood)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A280901D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:59:09.812Z</lastUpdated>
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    <udiDi>06976753474549</udiDi>
    <basicUdiDi>B-06976753474549</basicUdiDi>
    <tradeName>Malaria P.f. Rapid Test Device (whole blood)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A270901D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:59:08.205Z</lastUpdated>
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    <udiDi>06976202763118</udiDi>
    <basicUdiDi>B-06976202763118</basicUdiDi>
    <tradeName>Giardia Lamblia Rapid Test</tradeName>
    <deviceName>Giardia Lamblia Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050208</emdnCode>
    <emdnDescription>GIARDIA LAMBLIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GIGIL-602</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:39:04.932Z</lastUpdated>
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  <row>
    <udiDi>06976202763002</udiDi>
    <basicUdiDi>B-06976202763002</basicUdiDi>
    <tradeName>Giardia Rapid Test</tradeName>
    <deviceName>Giardia Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050208</emdnCode>
    <emdnDescription>GIARDIA LAMBLIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GIGI-602</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:38:51.426Z</lastUpdated>
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  <row>
    <udiDi>06976202762487</udiDi>
    <basicUdiDi>B-06976202762487</basicUdiDi>
    <tradeName>Chagas Ab Rapid Test</tradeName>
    <deviceName>Chagas Ab Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050202</emdnCode>
    <emdnDescription>CHAGAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GICA-402</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:37:13.556Z</lastUpdated>
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    <udiDi>08435440209751</udiDi>
    <basicUdiDi>84354402_MDXVECTOR_CHAH5</basicUdiDi>
    <tradeName>VIASURE Trypanosoma cruzi Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105050302</emdnCode>
    <emdnDescription>CHAGAS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-CHA112L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:56:06.714Z</lastUpdated>
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    <udiDi>08435440226291</udiDi>
    <basicUdiDi>84354402_MDXVECTOR_CHAH5</basicUdiDi>
    <tradeName>VIASURE Trypanosoma cruzi Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105050302</emdnCode>
    <emdnDescription>CHAGAS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-CHA101H</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:56:06.412Z</lastUpdated>
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    <udiDi>08435440226284</udiDi>
    <basicUdiDi>84354402_MDXVECTOR_CHAH5</basicUdiDi>
    <tradeName>VIASURE Trypanosoma cruzi Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105050302</emdnCode>
    <emdnDescription>CHAGAS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-CHA101L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:56:06.297Z</lastUpdated>
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    <udiDi>08435440215950</udiDi>
    <basicUdiDi>84354402_MDXVECTOR_CHAH5</basicUdiDi>
    <tradeName>VIASURE Trypanosoma cruzi Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105050302</emdnCode>
    <emdnDescription>CHAGAS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-CHA112LE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:56:06.226Z</lastUpdated>
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    <udiDi>08435440209782</udiDi>
    <basicUdiDi>84354402_MDXVECTOR_CHAH5</basicUdiDi>
    <tradeName>VIASURE Trypanosoma cruzi Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105050302</emdnCode>
    <emdnDescription>CHAGAS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-CHA112H</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:56:04.307Z</lastUpdated>
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    <udiDi>08435440209768</udiDi>
    <basicUdiDi>84354402_MDXVECTOR_CHAH5</basicUdiDi>
    <tradeName>VIASURE Trypanosoma cruzi Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105050302</emdnCode>
    <emdnDescription>CHAGAS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-CHA113L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:56:03.758Z</lastUpdated>
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    <udiDi>08435440209799</udiDi>
    <basicUdiDi>84354402_MDXVECTOR_CHAH5</basicUdiDi>
    <tradeName>VIASURE Trypanosoma cruzi Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105050302</emdnCode>
    <emdnDescription>CHAGAS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-CHA113H</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:56:03.455Z</lastUpdated>
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    <udiDi>08435440226345</udiDi>
    <basicUdiDi>84354402_MDXVECTOR_CHAH5</basicUdiDi>
    <tradeName>VIASURE Trypanosoma cruzi Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105050302</emdnCode>
    <emdnDescription>CHAGAS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-CHA196T</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:56:02.905Z</lastUpdated>
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    <udiDi>08435440226260</udiDi>
    <basicUdiDi>84354402_MDXVECTOR_CHAH5</basicUdiDi>
    <tradeName>VIASURE Trypanosoma cruzi Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105050302</emdnCode>
    <emdnDescription>CHAGAS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-CHA101</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:55:58.305Z</lastUpdated>
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    <udiDi>08435440211402</udiDi>
    <basicUdiDi>84354402_MDXVECTOR_CHAH5</basicUdiDi>
    <tradeName>VIASURE Trypanosoma cruzi Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105050302</emdnCode>
    <emdnDescription>CHAGAS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-CHA136</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:55:57.823Z</lastUpdated>
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    <udiDi>08435440211419</udiDi>
    <basicUdiDi>84354402_MDXVECTOR_CHAH5</basicUdiDi>
    <tradeName>VIASURE Trypanosoma cruzi Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105050302</emdnCode>
    <emdnDescription>CHAGAS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-CHA172</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:55:57.302Z</lastUpdated>
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    <udiDi>08435440226307</udiDi>
    <basicUdiDi>84354402_MDXVECTOR_CHAH5</basicUdiDi>
    <tradeName>VIASURE Trypanosoma cruzi Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105050302</emdnCode>
    <emdnDescription>CHAGAS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-CHA101LE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:55:55.215Z</lastUpdated>
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    <udiDi>08435440226314</udiDi>
    <basicUdiDi>84354402_MDXVECTOR_CHAH5</basicUdiDi>
    <tradeName>VIASURE Trypanosoma cruzi Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105050302</emdnCode>
    <emdnDescription>CHAGAS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-CHA101HE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:55:54.151Z</lastUpdated>
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