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    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
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    <tradeName>VIASURE H. pylori + Clarithromycin resistance Real Time PCR Detection Kit</tradeName>
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    <tradeName>VIASURE H. pylori + Clarithromycin resistance Real Time PCR Detection Kit</tradeName>
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    <tradeName>VIASURE H. pylori + Clarithromycin resistance Real Time PCR Detection Kit</tradeName>
    <deviceName>VIASURE H. pylori + Clarithromycin resistance Real Time PCR Detection Kit</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
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    <emdnDescription>H. PYLORI DETECTION BY NA REAGENTS</emdnDescription>
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    <lastUpdated>2026-07-16T09:19:39.398Z</lastUpdated>
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    <udiDi>D-G2M706321FL</udiDi>
    <basicUdiDi>B-G2M706321FL</basicUdiDi>
    <tradeName>H. Pylori-Q Real-Time PCR Kit</tradeName>
    <deviceName>H. Pylori-Q Real-Time PCR Kit</deviceName>
    <manufacturerName>Genes 2Me Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000035953</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-13T20:43:51.507Z</lastUpdated>
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    <udiDi>08685115807632</udiDi>
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    <tradeName>LyoSens  H. pylori qPCR Kit</tradeName>
    <deviceName>H. pylori qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>H. PYLORI DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>LyoSens  H.pylori/Clarithromycin Genotyping qPCR Kit</tradeName>
    <deviceName>H.pylori/Clarithromycin Genotyping qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
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    <lastUpdated>2026-07-09T03:23:04.594Z</lastUpdated>
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    <udiDi>08684387210874</udiDi>
    <basicUdiDi>B-08684387210874</basicUdiDi>
    <tradeName>RevoDx Helicobacter pylori qPCR Kit</tradeName>
    <deviceName>RevoDx Helicobacter pylori qPCR Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
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    <emdnDescription>H. PYLORI DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-08T22:47:58.194Z</lastUpdated>
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    <udiDi>08684387210355</udiDi>
    <basicUdiDi>B-08684387210355</basicUdiDi>
    <tradeName>RevoDx Helicobacter pylori qPCR Kit</tradeName>
    <deviceName>RevoDx Helicobacter pylori qPCR Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>H. PYLORI DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202405-100</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:46:58.791Z</lastUpdated>
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    <udiDi>06971042229527</udiDi>
    <basicUdiDi>B-06971042229527</basicUdiDi>
    <tradeName>Helicobacter Pylori Real Time PCR Kit</tradeName>
    <deviceName>Helicobacter Pylori 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>W0105010403</emdnCode>
    <emdnDescription>H. PYLORI DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD-0354-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:06:28.340Z</lastUpdated>
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    <basicUdiDi>B-06971042229510</basicUdiDi>
    <tradeName>Helicobacter Pylori and Toxin (VacA/CagA) Real Time PCR Kit</tradeName>
    <deviceName>Helicobacter Pylori and Toxin (VacA/CagA) 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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    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>H. PYLORI DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD-0318-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:06:26.291Z</lastUpdated>
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    <udiDi>04049055001217</udiDi>
    <basicUdiDi>B-04049055001217</basicUdiDi>
    <tradeName>GenoType HelicoDR VER 1.0</tradeName>
    <deviceName>GenoType HelicoDR VER 1.0</deviceName>
    <manufacturerName>Hain Lifescience GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008606</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>H. PYLORI DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-06T00:03:53.807Z</lastUpdated>
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    <udiDi>D-000012807175096R2</udiDi>
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    <tradeName>Helicobacter Pylori and Toxin Nucleic Acid Detection Kit (Fluorescence PCR)</tradeName>
    <deviceName>Helicobacter Pylori and Toxin Nucleic Acid Detection Kit (Fluorescence PCR)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
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    <emdnDescription>H. PYLORI DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-OT139</reference>
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    <lastUpdated>2026-07-04T05:59:19.649Z</lastUpdated>
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    <udiDi>04049095161742</udiDi>
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    <deviceName>RIDA®Prime H. pylori BDM</deviceName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>H. PYLORI DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-01T15:52:23.304Z</lastUpdated>
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    <deviceName>Clarithromycin, Quinolone-Resistant and Non-Resistant Helicobacter Pylori Nucleic Acid Amplification Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
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    <reference>B052T010B0C2</reference>
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    <lastUpdated>2026-06-30T06:57:53.413Z</lastUpdated>
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    <deviceName>H. Pylori and Multi-Antibiotic Resistance Real-Time PCR Kit</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <lastUpdated>2026-06-30T06:56:53.372Z</lastUpdated>
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    <deviceName>H. Pylori and Multi-Antibiotic Resistance Real-Time PCR Kit</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
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    <deviceName>Multi-Antibiotic Resistant H.pylori Strain Real Time PCR Detection Kit</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
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    <deviceName>Multi-Antibiotic Resistant H.pylori Strain Real Time PCR Detection Kit</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
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    <deviceName>Clarithromycin, Quinolone-Resistant and Non-Resistant Helicobacter Pylori Nucleic Acid Amplification Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>B05201T2048</reference>
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    <lastUpdated>2026-06-30T06:56:14.950Z</lastUpdated>
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