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    <tradeName>Allplex™ MTB/MDRe Detection</tradeName>
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    <manufacturerName>Seegene, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022275</manufacturerSrn>
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    <udiDi>08809240103852</udiDi>
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    <tradeName>Allplex™ MTB/MDR/XDRe Detection</tradeName>
    <deviceName>Allplex™ MTB/MDR/XDRe Detection</deviceName>
    <manufacturerName>Seegene, Inc.</manufacturerName>
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    <tradeName>Anyplex™ MTB/NTMe Real-time Detection</tradeName>
    <deviceName>Anyplex™ MTB/NTMe Real-time Detection</deviceName>
    <manufacturerName>Seegene, Inc.</manufacturerName>
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    <tradeName>Allplex™ MTB/MDR/XDRe Detection</tradeName>
    <deviceName>Allplex™ MTB/MDR/XDRe Detection</deviceName>
    <manufacturerName>Seegene, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022275</manufacturerSrn>
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    <emdnDescription>MYCOBACTERIA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB10174X</reference>
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    <lastUpdated>2026-07-10T09:44:09.448Z</lastUpdated>
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    <udiDi>08809240101735</udiDi>
    <basicUdiDi>B-08809240101735</basicUdiDi>
    <tradeName>Allplex™ MTB/MDR/XDRe Detection</tradeName>
    <deviceName>Allplex™ MTB/MDR/XDRe Detection</deviceName>
    <manufacturerName>Seegene, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022275</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB10173Y</reference>
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    <lastUpdated>2026-07-10T09:44:08.640Z</lastUpdated>
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    <udiDi>08809240101179</udiDi>
    <basicUdiDi>B-08809240101179</basicUdiDi>
    <tradeName>Allplex™ MTB/XDRe Detection</tradeName>
    <deviceName>Allplex™ MTB/XDRe Detection</deviceName>
    <manufacturerName>Seegene, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022275</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <emdnDescription>MYCOBACTERIA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB9500X</reference>
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    <tradeName>Allplex™ MTB/MDRe Detection</tradeName>
    <deviceName>Allplex™ MTB/MDRe Detection</deviceName>
    <manufacturerName>Seegene, Inc.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-10T09:43:51.840Z</lastUpdated>
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    <tradeName>Allplex™ MTB/XDRe Detection</tradeName>
    <deviceName>Allplex™ MTB/XDRe Detection</deviceName>
    <manufacturerName>Seegene, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022275</manufacturerSrn>
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    <emdnDescription>MYCOBACTERIA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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    <udiDi>08809240101155</udiDi>
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    <tradeName>Allplex™ MTB/MDRe Detection</tradeName>
    <deviceName>Allplex™ MTB/MDRe Detection</deviceName>
    <manufacturerName>Seegene, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022275</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>MYCOBACTERIA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB9400X</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:43:49.544Z</lastUpdated>
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    <udiDi>08809240100516</udiDi>
    <basicUdiDi>B-08809240100516</basicUdiDi>
    <tradeName>Anyplex™ MTB/NTMe Real-time Detection</tradeName>
    <deviceName>Anyplex™ MTB/NTMe Real-time Detection</deviceName>
    <manufacturerName>Seegene, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022275</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB7202X</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:43:00.544Z</lastUpdated>
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    <udiDi>08809240100509</udiDi>
    <basicUdiDi>B-08809240100509</basicUdiDi>
    <tradeName>Anyplex™ MTB/NTMe Real-time Detection</tradeName>
    <deviceName>Anyplex™ MTB/NTMe Real-time Detection</deviceName>
    <manufacturerName>Seegene, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022275</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB7202Y</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:43:00.447Z</lastUpdated>
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    <udiDi>08800097500115</udiDi>
    <basicUdiDi>B-08800097500115</basicUdiDi>
    <tradeName>PaxView TB MPCR-ULFA Kit</tradeName>
    <deviceName>PaxView TB MPCR-ULFA Kit</deviceName>
    <manufacturerName>PaxGenBio Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000024696</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V0431</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:24:19.138Z</lastUpdated>
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    <udiDi>08800097500009</udiDi>
    <basicUdiDi>B-08800097500009</basicUdiDi>
    <tradeName>PaxView TB/NTM MPCR-ULFA Kit</tradeName>
    <deviceName>PaxView TB/NTM MPCR-ULFA Kit</deviceName>
    <manufacturerName>PaxGenBio Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000024696</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:24:11.915Z</lastUpdated>
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    <udiDi>08800056301005</udiDi>
    <basicUdiDi>B-08800056301005</basicUdiDi>
    <tradeName>PowerChek™ MTB/NTM Real-time PCR Kit</tradeName>
    <deviceName>PowerChek™ MTB/NTM Real-time PCR Kit</deviceName>
    <manufacturerName>KogeneBiotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000045858</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>IR0120</reference>
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    <lastUpdated>2026-07-09T22:32:03.525Z</lastUpdated>
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    <udiDi>08719326569963</udiDi>
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    <tradeName>RealAccurate® Quadruplex Mycobacteria PCR kit</tradeName>
    <deviceName>RealAccurate® Quadruplex Mycobacteria PCR kit</deviceName>
    <manufacturerName>PathoFinder B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000002704</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <reference>PF0920-R</reference>
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    <lastUpdated>2026-07-09T16:05:06.535Z</lastUpdated>
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    <udiDi>08698898740072</udiDi>
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    <tradeName>Fluorion</tradeName>
    <deviceName>Fluorion MTBC QLP 2.1 Real-Time PCR Kit</deviceName>
    <manufacturerName>IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.</manufacturerName>
    <manufacturerSrn>TR-MF-000023054</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0030102</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T11:59:54.837Z</lastUpdated>
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    <tradeName>SOFTEC Tuberculosis Rapid Test Kit</tradeName>
    <deviceName>Tuberculosis Rapid Test Kit</deviceName>
    <manufacturerName>ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000046897</manufacturerSrn>
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    <tradeName>LyoSens MTB/non-TB Genotyping qPCR Kit</tradeName>
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    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
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    <tradeName>ChainFor Mycobacterium Tuberculosis Detection RT-qPCR Kit</tradeName>
    <deviceName>Mycobacterium Tuberculosis Detection RT-qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
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    <tradeName>RapidFor™ Tuberculosis IgG/IgM Rapid Test Kit</tradeName>
    <deviceName>Tuberculosis IgG/IgM Rapid Test Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
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