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    <basicUdiDi>880024299K45773N</basicUdiDi>
    <tradeName>ExiPrep™ 48 SF Genomic DNA Kit</tradeName>
    <deviceName>ExiPrep™ 48 SF Genomic DNA Kit</deviceName>
    <manufacturerName>BIONEER Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000018672</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-4577</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:36:12.528Z</lastUpdated>
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    <udiDi>08800242990136</udiDi>
    <basicUdiDi>880024299K45783Q</basicUdiDi>
    <tradeName>ExiPrep™ 48 SF Viral DNA/RNA Kit</tradeName>
    <deviceName>ExiPrep™ 48 SF Viral DNA/RNA Kit</deviceName>
    <manufacturerName>BIONEER Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000018672</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-4578</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:36:11.741Z</lastUpdated>
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    <udiDi>08800151200142</udiDi>
    <basicUdiDi>88001512W73052-1002Q</basicUdiDi>
    <tradeName>08800151200142</tradeName>
    <deviceName>WizPrep™ Viral DNA/RNA Mini Kit (V2)</deviceName>
    <manufacturerName>Wizbiosolutions Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000024896</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W73052-100</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:34:16.340Z</lastUpdated>
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    <udiDi>08800118520511</udiDi>
    <basicUdiDi>88001185HR0020513L</basicUdiDi>
    <tradeName>08800118520511</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genesystem Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000022998</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9799140106</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:33:13.139Z</lastUpdated>
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    <udiDi>08800118520412</udiDi>
    <basicUdiDi>88001185HR0020413H</basicUdiDi>
    <tradeName>08800118520412</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genesystem Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000022998</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9799140105</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:33:08.243Z</lastUpdated>
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    <udiDi>08800111718557</udiDi>
    <basicUdiDi>88001117IPAA01MA13W9</basicUdiDi>
    <tradeName>STANDARD™ M10 Stool Pretreatment kit</tradeName>
    <deviceName>STANDARD™ M10 Stool Pretreatment Kit</deviceName>
    <manufacturerName>SD Biosensor Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009168</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900201</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11PRT20A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:30:21.706Z</lastUpdated>
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    <udiDi>08800111718540</udiDi>
    <basicUdiDi>88001117IPAA01MA11W5</basicUdiDi>
    <tradeName>STANDARD™ M10 Sputum Pretreatment Kit</tradeName>
    <deviceName>STANDARD™ M10 Sputum Pretreatment Kit</deviceName>
    <manufacturerName>SD Biosensor Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009168</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900201</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M10-SPTP-01/11PRT10A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:30:20.083Z</lastUpdated>
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    <udiDi>08800097500085</udiDi>
    <basicUdiDi>880009750008D7</basicUdiDi>
    <tradeName>PaxView DNA Extraction Kit</tradeName>
    <deviceName>PaxView DNA Extraction Kit</deviceName>
    <manufacturerName>PaxGenBio Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000024696</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V0101F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:29:26.428Z</lastUpdated>
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    <udiDi>08800056300060</udiDi>
    <basicUdiDi>88000563E00195H</basicUdiDi>
    <tradeName>PowerPrep™ Pathogen NA Extraction Kit EXP</tradeName>
    <deviceName>PowerPrep™ Pathogen NA Extraction Kit EXP</deviceName>
    <manufacturerName>KogeneBiotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000045858</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E0019</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:26:40.548Z</lastUpdated>
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    <udiDi>08800056300046</udiDi>
    <basicUdiDi>88000563E00185F</basicUdiDi>
    <tradeName>PowerPrep™ Whole blood NA Extraction Kit EXP</tradeName>
    <deviceName>PowerPrep™ Whole blood NA Extraction Kit EXP</deviceName>
    <manufacturerName>KogeneBiotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000045858</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E0018</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:26:39.778Z</lastUpdated>
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    <udiDi>08800056300022</udiDi>
    <basicUdiDi>88000563E00175D</basicUdiDi>
    <tradeName>PowerPrep™ Viral NA Extraction Kit EXP</tradeName>
    <deviceName>PowerPrep™ Viral NA Extraction Kit EXP</deviceName>
    <manufacturerName>KogeneBiotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000045858</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E0017</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:26:39.076Z</lastUpdated>
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    <udiDi>08800056300015</udiDi>
    <basicUdiDi>88000563E00165B</basicUdiDi>
    <tradeName>PowerPrep™ Viral DNA/RNA Extraction Kit Ver.1.0</tradeName>
    <deviceName>PowerPrep™ Viral DNA/RNA Extraction Kit Ver.1.0</deviceName>
    <manufacturerName>KogeneBiotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000045858</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E0016</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:26:37.356Z</lastUpdated>
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    <udiDi>08720299808744</udiDi>
    <basicUdiDi>87202998087CNGS77</basicUdiDi>
    <tradeName>CleanNGS Dx</tradeName>
    <deviceName>CleanNGS Dx</deviceName>
    <manufacturerName>CleanNA B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000022870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CNGS-0500CE</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T16:53:06.629Z</lastUpdated>
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    <udiDi>08720299808713</udiDi>
    <basicUdiDi>87202998087CQV8Y</basicUdiDi>
    <tradeName>Clean Quick Viral</tradeName>
    <deviceName>Clean Quick Viral</deviceName>
    <manufacturerName>CleanNA B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000022870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CQV-DR0500</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T16:53:05.882Z</lastUpdated>
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    <udiDi>08720299808706</udiDi>
    <basicUdiDi>87202998087CCF6N</basicUdiDi>
    <tradeName>Clean cell free DNA kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CleanNA B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000022870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CCF-D0384</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T16:53:05.023Z</lastUpdated>
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    <udiDi>08719326750965</udiDi>
    <basicUdiDi>87193267509PN-502EX</basicUdiDi>
    <tradeName>PathoNostics Extraction kit</tradeName>
    <deviceName>PathoNostics Extraction kit</deviceName>
    <manufacturerName>PathoNostics B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000002705</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PN-502</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T16:35:17.151Z</lastUpdated>
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    <udiDi>08698918034808</udiDi>
    <basicUdiDi>86989180309015AG</basicUdiDi>
    <tradeName>RTA MB VIRAL NUCLEIC ACID ISOLATION KIT (12 Tests)</tradeName>
    <deviceName>Nucleic Acid Isolation Kit (Magnetic Bead Method)</deviceName>
    <manufacturerName>RTA Laboratuvarları Biyolojik Ürünler İlaç ve Makine Sanayi Ticaret Anonim Şirketi</manufacturerName>
    <manufacturerSrn>TR-MF-000021258</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09015012</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:55:03.216Z</lastUpdated>
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    <udiDi>08698918032644</udiDi>
    <basicUdiDi>86989180309029AT</basicUdiDi>
    <tradeName>RTA VIRAL NUCLEIC ACID ISOLATION KIT (50 TESTS)</tradeName>
    <deviceName>Nucleic Acid Isolation Kit</deviceName>
    <manufacturerName>RTA Laboratuvarları Biyolojik Ürünler İlaç ve Makine Sanayi Ticaret Anonim Şirketi</manufacturerName>
    <manufacturerSrn>TR-MF-000021258</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09029050</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:54:47.875Z</lastUpdated>
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    <udiDi>08698918032613</udiDi>
    <basicUdiDi>86989180309010A6</basicUdiDi>
    <tradeName>RTA VIRAL RNA ISOLATION KIT (50 TESTS)</tradeName>
    <deviceName>Nucleic Acid Isolation Kit</deviceName>
    <manufacturerName>RTA Laboratuvarları Biyolojik Ürünler İlaç ve Makine Sanayi Ticaret Anonim Şirketi</manufacturerName>
    <manufacturerSrn>TR-MF-000021258</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09010050</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:54:47.057Z</lastUpdated>
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    <udiDi>08684998270250</udiDi>
    <basicUdiDi>868499827VIRA09P100Z2</basicUdiDi>
    <tradeName>ViraSens Total Nucleic Acid Purification Kit</tradeName>
    <deviceName>Total Nucleic Acid Purification Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VIRA09</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:39:40.204Z</lastUpdated>
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