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    <deviceName>G-6-PDH</deviceName>
    <manufacturerName>Medicon Hellas SA</manufacturerName>
    <manufacturerSrn>GR-MF-000013625</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <reference>1517-0910</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
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    <tradeName>Glucose-6-Phosphate Dehydrogenase (G-6-PD) Quantitative Assay</tradeName>
    <deviceName>Glucose-6-Phosphate Dehydrogenase (G-6-PD) Quantitative Assay</deviceName>
    <manufacturerName>Kalians Corporation</manufacturerName>
    <manufacturerSrn>EG-MF-000050142</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
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    <tradeName>G6PD - single reagent</tradeName>
    <deviceName>G6PD - single reagent</deviceName>
    <manufacturerName>Egyptian Company For Biotechnology-Spectrum Diagnostics</manufacturerName>
    <manufacturerSrn>EG-MF-000032599</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
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    <reference>253 001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:24:37.720Z</lastUpdated>
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    <udiDi>62230041022406</udiDi>
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    <tradeName>G6PD</tradeName>
    <deviceName>G6PD</deviceName>
    <manufacturerName>Egyptian Company For Biotechnology-Spectrum Diagnostics</manufacturerName>
    <manufacturerSrn>EG-MF-000032599</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103019001</emdnCode>
    <emdnDescription>CELLULAR ENZYME DETERMINATION REAGENTS (G-6-PDH, PYUVATE KINASE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>252 001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:24:34.892Z</lastUpdated>
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    <udiDi>08809446080988</udiDi>
    <basicUdiDi>B-08809446080988</basicUdiDi>
    <tradeName>08809446080988</tradeName>
    <deviceName>careSTART™ G6PD Biosensor Strip</deviceName>
    <manufacturerName>WELLS BIO, INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000031789</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103019001</emdnCode>
    <emdnDescription>CELLULAR ENZYME DETERMINATION REAGENTS (G-6-PDH, PYUVATE KINASE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BGS-E02582</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:10:02.319Z</lastUpdated>
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    <udiDi>08809446080971</udiDi>
    <basicUdiDi>B-08809446080971</basicUdiDi>
    <tradeName>08809446080971</tradeName>
    <deviceName>careSTART™ S1 G6PD Strip</deviceName>
    <manufacturerName>WELLS BIO, INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000031789</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103019001</emdnCode>
    <emdnDescription>CELLULAR ENZYME DETERMINATION REAGENTS (G-6-PDH, PYUVATE KINASE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSG-E02582</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:09:58.688Z</lastUpdated>
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    <basicUdiDi>5204309000023NN</basicUdiDi>
    <tradeName>G-6-PDH</tradeName>
    <deviceName>G-6-PDH</deviceName>
    <manufacturerName>Medicon Hellas SA</manufacturerName>
    <manufacturerSrn>GR-MF-000013625</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103019001</emdnCode>
    <emdnDescription>CELLULAR ENZYME DETERMINATION REAGENTS (G-6-PDH, PYUVATE KINASE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1418-0910</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:52:57.173Z</lastUpdated>
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    <udiDi>06936595750669</udiDi>
    <basicUdiDi>B-06936595750669</basicUdiDi>
    <tradeName>Glucose-6-Phosphate Dehydrogenase Kit (Kinetic Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103019001</emdnCode>
    <emdnDescription>CELLULAR ENZYME DETERMINATION REAGENTS (G-6-PDH, PYUVATE KINASE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MJ445Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:54:59.413Z</lastUpdated>
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    <basicUdiDi>5204309000023NN</basicUdiDi>
    <tradeName>G-6-PDH</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medicon Hellas SA</manufacturerName>
    <manufacturerSrn>GR-MF-000013625</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103019001</emdnCode>
    <emdnDescription>CELLULAR ENZYME DETERMINATION REAGENTS (G-6-PDH, PYUVATE KINASE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1415-0910</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-20T00:19:53.060Z</lastUpdated>
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    <udiDi>05204309156399</udiDi>
    <basicUdiDi>B-05204309156399</basicUdiDi>
    <tradeName>G-6-PDH</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medicon Hellas SA</manufacturerName>
    <manufacturerSrn>GR-MF-000013625</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103019001</emdnCode>
    <emdnDescription>CELLULAR ENZYME DETERMINATION REAGENTS (G-6-PDH, PYUVATE KINASE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>141G-0910</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-20T00:19:02.881Z</lastUpdated>
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    <udiDi>05204309137459</udiDi>
    <basicUdiDi>5204309000023NN</basicUdiDi>
    <tradeName>G-6-PDH</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medicon Hellas SA</manufacturerName>
    <manufacturerSrn>GR-MF-000013625</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103019001</emdnCode>
    <emdnDescription>CELLULAR ENZYME DETERMINATION REAGENTS (G-6-PDH, PYUVATE KINASE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1417-0910</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-20T00:18:36.720Z</lastUpdated>
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    <udiDi>05204309132997</udiDi>
    <basicUdiDi>5204309000023NN</basicUdiDi>
    <tradeName>G-6-PDH</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medicon Hellas SA</manufacturerName>
    <manufacturerSrn>GR-MF-000013625</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103019001</emdnCode>
    <emdnDescription>CELLULAR ENZYME DETERMINATION REAGENTS (G-6-PDH, PYUVATE KINASE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1419-0912</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-20T00:17:46.079Z</lastUpdated>
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