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    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <tradeName>Evo Specific Standard G4</tradeName>
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    <tradeName>Evo Specific Standard E</tradeName>
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    <manufacturerName>ABD SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000029729</manufacturerSrn>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <tradeName>MeMed BV® Calibrator</tradeName>
    <deviceName>MeMed BV® Calibrator</deviceName>
    <manufacturerName>MeMed Diagnostics Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000023622</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG31001</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T22:30:38.979Z</lastUpdated>
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    <tradeName>CRP LATEX CALIBRATOR</tradeName>
    <deviceName>CRP LATEX</deviceName>
    <manufacturerName>Medicon Hellas SA</manufacturerName>
    <manufacturerSrn>GR-MF-000013625</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>1478-0529</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:53:33.200Z</lastUpdated>
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    <tradeName>Access AMH Calibrators</tradeName>
    <deviceName>Access AMH Calibrators</deviceName>
    <manufacturerName>IMMUNOTECH SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000011121</manufacturerSrn>
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    <lastUpdated>2026-07-01T08:49:27.752Z</lastUpdated>
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    <tradeName>Access PAPP-A Calibrators</tradeName>
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    <manufacturerName>IMMUNOTECH SAS</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-01T08:48:24.467Z</lastUpdated>
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    <tradeName>Digitoxin Calibrator</tradeName>
    <deviceName>Digitoxin Calibrator</deviceName>
    <manufacturerName>Beckman Coulter Ireland Inc.</manufacturerName>
    <manufacturerSrn>IE-MF-000000887</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>ODC6403</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:45:04.179Z</lastUpdated>
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    <tradeName>Access MeMed BV Calibrator (Kit)</tradeName>
    <deviceName>Access MeMed BV Calibrator (Kit)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>D05592</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:40:23.929Z</lastUpdated>
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    <tradeName>Access Total T4 II Calibrators</tradeName>
    <deviceName>Access Total T4 II Calibrators</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>C69048</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:40:15.128Z</lastUpdated>
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    <tradeName>Access Progesterone II Sample Diluent</tradeName>
    <deviceName>Access Progesterone II Sample Diluent</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>C81798</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:40:11.120Z</lastUpdated>
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    <tradeName>Access Progesterone II Calibrators</tradeName>
    <deviceName>Access Progesterone II Calibrators</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>C78021</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:40:09.521Z</lastUpdated>
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    <tradeName>Access C-Peptide (Calibrators)</tradeName>
    <deviceName>Access C-Peptide (Calibrators)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>C31860</reference>
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    <lastUpdated>2026-07-01T08:39:31.830Z</lastUpdated>
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    <tradeName>Access Unconjugated Estriol (Calibrators)</tradeName>
    <deviceName>Access Unconjugated Estriol (Calibrators)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
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    <lastUpdated>2026-07-01T08:39:21.414Z</lastUpdated>
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    <deviceName>Access Sensitive Estradiol Calibrator S0</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
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    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
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    <lastUpdated>2026-07-01T08:39:14.215Z</lastUpdated>
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    <tradeName>Access 25(OH) Vitamin D Total Calibrators</tradeName>
    <deviceName>Access 25(OH) Vitamin D Total Calibrators</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
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    <tradeName>Access 25(OH) Vitamin D Total Calibrators</tradeName>
    <deviceName>Access 25(OH) Vitamin D Total Calibrators</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
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    <tradeName>Access hFSH Calibrators</tradeName>
    <deviceName>Access hFSH Calibrators</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
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