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<eudamedExport entity="devices">
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    <udiDi>08800056302019</udiDi>
    <basicUdiDi>B-08800056302019</basicUdiDi>
    <tradeName>PowerChek™ Adeno / Astro / Rota Real-time PCR Kit</tradeName>
    <deviceName>PowerChek™ Adeno / Astro / Rota Real-time PCR Kit</deviceName>
    <manufacturerName>KogeneBiotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000045858</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R0211E</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:32:08.329Z</lastUpdated>
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  <row>
    <udiDi>08436040328712</udiDi>
    <basicUdiDi>843604032RTPCR00401VK</basicUdiDi>
    <tradeName>ZIKV/DENV/CHIKV REALTIME PCR KIT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vircell, S.L</manufacturerName>
    <manufacturerSrn>ES-MF-000004099</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105070506</emdnCode>
    <emdnDescription>TROPICAL FEVER - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTPCR004-LP</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:49:05.862Z</lastUpdated>
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    <udiDi>08436040329917</udiDi>
    <basicUdiDi>843604032RTPCR02101VJ</basicUdiDi>
    <tradeName>SARS-CoV-2/FluA/FluB/RSV REAL TIME PCR KIT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vircell, S.L</manufacturerName>
    <manufacturerSrn>ES-MF-000004099</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTPCR021-LPD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:49:05.674Z</lastUpdated>
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    <udiDi>08698898741055</udiDi>
    <basicUdiDi>B-08698898741055</basicUdiDi>
    <tradeName>Fluorion</tradeName>
    <deviceName>Fluorion Covidenza Plus QLP 3.0 Real-Time PCR Kit</deviceName>
    <manufacturerName>IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.</manufacturerName>
    <manufacturerSrn>TR-MF-000023054</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M1390102</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T12:00:31.716Z</lastUpdated>
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  <row>
    <udiDi>08698898741048</udiDi>
    <basicUdiDi>B-08698898741048</basicUdiDi>
    <tradeName>Fluorion</tradeName>
    <deviceName>Fluorion Covidenza Plus QLP 2.0 Real-Time PCR Kit</deviceName>
    <manufacturerName>IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.</manufacturerName>
    <manufacturerSrn>TR-MF-000023054</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M1380102</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T12:00:26.113Z</lastUpdated>
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  <row>
    <udiDi>08698898741031</udiDi>
    <basicUdiDi>B-08698898741031</basicUdiDi>
    <tradeName>Fluorion</tradeName>
    <deviceName>Fluorion Covidenza Plus QLP 1.0 Real-Time PCR Kit</deviceName>
    <manufacturerName>IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.</manufacturerName>
    <manufacturerSrn>TR-MF-000023054</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M1370102</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T12:00:25.415Z</lastUpdated>
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  <row>
    <udiDi>08698898741000</udiDi>
    <basicUdiDi>B-08698898741000</basicUdiDi>
    <tradeName>Fluorion</tradeName>
    <deviceName>Fluorion Covidenza QLP 1.0 Real-Time PCR Kit</deviceName>
    <manufacturerName>IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.</manufacturerName>
    <manufacturerSrn>TR-MF-000023054</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M1360102</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T12:00:08.465Z</lastUpdated>
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    <udiDi>08697962616312</udiDi>
    <basicUdiDi>B-08697962616312</basicUdiDi>
    <tradeName>SOFTEC SARS-CoV-2 Antigen Rapid Test Kit (Nasal Swab)</tradeName>
    <deviceName>SARS-CoV-2 Antigen Rapid Test Kit (Nasal Swab)</deviceName>
    <manufacturerName>ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000046897</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070399</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZET01N</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-09T04:21:53.579Z</lastUpdated>
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  <row>
    <udiDi>08685115807854</udiDi>
    <basicUdiDi>B-08685115807854</basicUdiDi>
    <tradeName>LyoSens Gastroenteritis ID-23 Genotyping qPCR Kit</tradeName>
    <deviceName>Gastroenteritis ID-23 Genotyping qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO133</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:23:10.204Z</lastUpdated>
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  <row>
    <udiDi>08685115806215</udiDi>
    <basicUdiDi>B-08685115806215</basicUdiDi>
    <tradeName>LyoSens Respiratory ID-7 Genotyping qPCR Kit</tradeName>
    <deviceName>Respiratory ID-7 Genotyping qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO117</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:22:55.794Z</lastUpdated>
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  <row>
    <udiDi>08685115805249</udiDi>
    <basicUdiDi>B-08685115805249</basicUdiDi>
    <tradeName>LyoSens Bacterial Meningitis Panel Genotyping qPCR Kit</tradeName>
    <deviceName>Bacterial Meningitis Panel Genotyping qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070505</emdnCode>
    <emdnDescription>MENINGITIS / ENCEPHALITIS INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO131</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:22:45.404Z</lastUpdated>
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  <row>
    <udiDi>08685115805003</udiDi>
    <basicUdiDi>B-08685115805003</basicUdiDi>
    <tradeName>LyoSens Atypical CAP Panel Genotyping qPCR Kit</tradeName>
    <deviceName>Atypical CAP Panel Genotyping qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO129</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:22:43.782Z</lastUpdated>
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  <row>
    <udiDi>08685115804884</udiDi>
    <basicUdiDi>B-08685115804884</basicUdiDi>
    <tradeName>LyoSens HSV-1/HSV-2/TP qPCR Kit</tradeName>
    <deviceName>HSV-1/HSV-2/TP qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070501</emdnCode>
    <emdnDescription>STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO128</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:22:43.004Z</lastUpdated>
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  <row>
    <udiDi>08684998279161</udiDi>
    <basicUdiDi>B-08684998279161</basicUdiDi>
    <tradeName>LyoSens UTI ID-26 Genotyping qPCR Kit</tradeName>
    <deviceName>UTI ID-26 Genotyping qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070201</emdnCode>
    <emdnDescription>GRAM+ - GRAM- - FUNGI - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO120</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:21:59.639Z</lastUpdated>
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  <row>
    <udiDi>08684998276382</udiDi>
    <basicUdiDi>B-08684998276382</basicUdiDi>
    <tradeName>LyoSens SARS-CoV-2/FLU/RSV Genotyping qPCR Kit</tradeName>
    <deviceName>SARS-CoV-2/FLU/RSV Genotyping qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070304</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:21:45.174Z</lastUpdated>
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  <row>
    <udiDi>08684595030622</udiDi>
    <basicUdiDi>B-08684595030622</basicUdiDi>
    <tradeName>RapidFor™ Vaginal pH Test</tradeName>
    <deviceName>Vaginal pH Test</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMD126</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:14:34.126Z</lastUpdated>
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  <row>
    <udiDi>08684387215565</udiDi>
    <basicUdiDi>B-08684387215565</basicUdiDi>
    <tradeName>RevoDx African Swine Fever Virus qPCR Kit</tradeName>
    <deviceName>RevoDx African Swine Fever Virus qPCR Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070506</emdnCode>
    <emdnDescription>TROPICAL FEVER - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202226-500</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T23:05:35.348Z</lastUpdated>
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  <row>
    <udiDi>08684387215558</udiDi>
    <basicUdiDi>B-08684387215558</basicUdiDi>
    <tradeName>RevoDx African Swine Fever Virus qPCR Kit</tradeName>
    <deviceName>RevoDx African Swine Fever Virus qPCR Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070506</emdnCode>
    <emdnDescription>TROPICAL FEVER - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P202226-100</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T23:05:34.544Z</lastUpdated>
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  <row>
    <udiDi>08684387215459</udiDi>
    <basicUdiDi>B-08684387215459</basicUdiDi>
    <tradeName>RevoDx Bacterial Respiratory Pathogen Detection Kit</tradeName>
    <deviceName>RevoDx Bacterial Respiratory Pathogen Detection Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202603-100</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T23:05:03.271Z</lastUpdated>
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  <row>
    <udiDi>08684387215442</udiDi>
    <basicUdiDi>B-08684387215442</basicUdiDi>
    <tradeName>RevoDx Bacterial Respiratory Pathogen Detection Kit</tradeName>
    <deviceName>RevoDx Bacterial Respiratory Pathogen Detection Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202603-50</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T23:04:59.285Z</lastUpdated>
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