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    <tradeName>ChainFor ETEC + EIEC Detection qPCR Kit</tradeName>
    <deviceName>ETEC + EIEC Detection qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <lastUpdated>2026-07-08T21:16:14.284Z</lastUpdated>
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    <udiDi>08683548257529</udiDi>
    <basicUdiDi>B-08683548257529</basicUdiDi>
    <tradeName>ChainFor EHEC + EPEC + EIEC Detection qPCR Kit</tradeName>
    <deviceName>EHEC + EPEC + EIEC Detection qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
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    <udiDi>08683548257352</udiDi>
    <basicUdiDi>B-08683548257352</basicUdiDi>
    <tradeName>ChainFor Shigella + EIEC Detection qPCR Kit</tradeName>
    <deviceName>Shigella + EIEC Detection qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
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    <deviceName>Five Strains of Diarrheagenic Escherichia coli Multi-Target Nucleic Acid Detection Kit (PCR Melting Curve Method)</deviceName>
    <manufacturerName>Igenesis(Shanghai)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001552</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011503</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>106-0147-01</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:50:35.350Z</lastUpdated>
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    <udiDi>06974858560839</udiDi>
    <basicUdiDi>B-06974858560839</basicUdiDi>
    <tradeName>06974858560839</tradeName>
    <deviceName>Escherichia Coli DNA Detection Kit (Fluorescence PCR Method)</deviceName>
    <manufacturerName>Suzhou TianLong Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001080</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011503</emdnCode>
    <emdnDescription>E. COLI DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P044H</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:00:01.008Z</lastUpdated>
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    <udiDi>06974323011309</udiDi>
    <basicUdiDi>B-06974323011309</basicUdiDi>
    <tradeName>06974323011309</tradeName>
    <deviceName>Real-time PCR Diagnostic Kit for Rapid Detection of Enterohemorrhagic E. coli (EHEC)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011503</emdnCode>
    <emdnDescription>E. COLI DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A5454</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:46:54.926Z</lastUpdated>
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    <basicUdiDi>B-06974323011293</basicUdiDi>
    <tradeName>06974323011293</tradeName>
    <deviceName>Real-time PCR Diagnostic Kit for Rapid Detection of Enterohemorrhagic E. coli (EHEC)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>E. COLI DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:46:54.136Z</lastUpdated>
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    <basicUdiDi>B-06971042225192</basicUdiDi>
    <tradeName>Enterotoxigenic E. Coli (ETEC) Real Time PCR Kit</tradeName>
    <deviceName>Enterotoxigenic E. Coli (ETEC) Real Time PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011599</emdnCode>
    <emdnDescription>E. COLI REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DD-0092-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:57:04.577Z</lastUpdated>
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    <udiDi>06971042225017</udiDi>
    <basicUdiDi>B-06971042225017</basicUdiDi>
    <tradeName>Diarrheagenic E.coli Genotype Real Time PCR Kit</tradeName>
    <deviceName>Diarrheagenic E.coli Genotype Real Time PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011503</emdnCode>
    <emdnDescription>E. COLI DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DD-0471-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:56:32.958Z</lastUpdated>
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    <udiDi>06971042224867</udiDi>
    <basicUdiDi>B-06971042224867</basicUdiDi>
    <tradeName>Enterohemorrhagic E.Coli (EHEC) Real Time PCR Kit</tradeName>
    <deviceName>Enterohemorrhagic E.Coli (EHEC) Real Time PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011503</emdnCode>
    <emdnDescription>E. COLI DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DD-0095-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:56:31.412Z</lastUpdated>
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    <udiDi>06971042224850</udiDi>
    <basicUdiDi>B-06971042224850</basicUdiDi>
    <tradeName>Enteroadhesive E.Coli (EAEC) Real Time PCR Kit</tradeName>
    <deviceName>Enteroadhesive E.Coli (EAEC) Real Time PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011503</emdnCode>
    <emdnDescription>E. COLI DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DD-0094-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:56:26.955Z</lastUpdated>
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    <udiDi>06971042224843</udiDi>
    <basicUdiDi>B-06971042224843</basicUdiDi>
    <tradeName>Enteroinvasive E.Coli (EIEC) Real Time PCR Kit</tradeName>
    <deviceName>Enteroinvasive E.Coli (EIEC) Real Time PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011503</emdnCode>
    <emdnDescription>E. COLI DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DD-0093-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:56:26.437Z</lastUpdated>
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    <udiDi>06971042224836</udiDi>
    <basicUdiDi>B-06971042224836</basicUdiDi>
    <tradeName>Enteropathogenic E.Coli (EPEC) Real Time PCR Kit</tradeName>
    <deviceName>Enteropathogenic E.Coli (EPEC) Real Time PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011503</emdnCode>
    <emdnDescription>E. COLI DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DD-0091-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:56:25.708Z</lastUpdated>
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    <udiDi>06971042224782</udiDi>
    <basicUdiDi>B-06971042224782</basicUdiDi>
    <tradeName>E. Coli O157：H7 Real Time PCR Kit</tradeName>
    <deviceName>E. Coli O157：H7 Real Time PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
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    <emdnCode>W0105011503</emdnCode>
    <emdnDescription>E. COLI DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DD-0039-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:56:17.284Z</lastUpdated>
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    <udiDi>04049095160424</udiDi>
    <basicUdiDi>B-04049095160424</basicUdiDi>
    <tradeName>04049095160424</tradeName>
    <deviceName>RIDA®GENE E. coli Stool Panel I</deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>E. COLI DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PG2285</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:06:24.326Z</lastUpdated>
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    <basicUdiDi>B-04049095160172</basicUdiDi>
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    <deviceName>RIDA®GENE EHEC/EPEC</deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>E. COLI DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PG2205</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:06:17.132Z</lastUpdated>
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    <deviceName>RIDA®UNITY E. coli Stool Panel III</deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>E. COLI DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UN2265</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:52:56.153Z</lastUpdated>
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    <deviceName>RIDA®UNITY E. coli Stool Panel I</deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
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    <emdnCode>W0105011503</emdnCode>
    <emdnDescription>E. COLI DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:52:51.323Z</lastUpdated>
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    <deviceName>RIDA®UNITY EHEC/EPEC</deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
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    <emdnDescription>E. COLI DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:52:43.334Z</lastUpdated>
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    <deviceName>RIDASCREEN® Verotoxin</deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011502</emdnCode>
    <emdnDescription>E. COLI TOXIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CRP2204</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:50:09.190Z</lastUpdated>
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