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    <tradeName>Vitamin D Control – botiss CARE Rapi-D™ Quantitative Vitamin D Test</tradeName>
    <deviceName>Vitamin D Control – botiss CARE Rapi-D™ Quantitative Vitamin D Test</deviceName>
    <manufacturerName>Affimedix, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000053178</manufacturerSrn>
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    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
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    <tradeName>Vitamin D Control – CrinoCheck® Vitamin D</tradeName>
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    <manufacturerName>Affimedix, Inc.</manufacturerName>
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    <basicUdiDi>B-00850082432158</basicUdiDi>
    <tradeName>Vitamin D Control – Rapi-D™ Quantitative Vitamin D Test</tradeName>
    <deviceName>Vitamin D Control – Rapi-D™ Quantitative Vitamin D Test</deviceName>
    <manufacturerName>Affimedix, Inc.</manufacturerName>
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    <tradeName>Control Kit - PHOS L1</tradeName>
    <deviceName>Control Kit - PHOS L1</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029697</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>92-201353-00</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:58:54.153Z</lastUpdated>
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    <udiDi>08430793041133</udiDi>
    <basicUdiDi>843079304113333</basicUdiDi>
    <tradeName>Aptiva® Optical Control Kit</tradeName>
    <deviceName>Aptiva® Optical Control Kit</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC1002</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:26:10.954Z</lastUpdated>
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    <udiDi>80575028800193</udiDi>
    <basicUdiDi>80575028800193U</basicUdiDi>
    <tradeName>Prism Control Clini5</tradeName>
    <deviceName>Prism Control Clini5</deviceName>
    <manufacturerName>Callegari S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000035568</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD-12060-A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T08:36:14.031Z</lastUpdated>
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    <udiDi>06936415986476</udiDi>
    <basicUdiDi>69449040004EFUN********G8</basicUdiDi>
    <tradeName>FUN Control</tradeName>
    <deviceName>Fructosamine (FUN) Kit (Colorimetric Assay)、FUN Control</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-020477-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:42:00.399Z</lastUpdated>
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    <udiDi>05902643962279</udiDi>
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    <tradeName>05902643962279</tradeName>
    <deviceName>BioPath R</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-814-0001</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:28:35.335Z</lastUpdated>
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    <tradeName>05902643962262</tradeName>
    <deviceName>BioNorm R</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-813-0001</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:28:34.551Z</lastUpdated>
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    <udiDi>05902643962255</udiDi>
    <basicUdiDi>59026439CBCH812BP</basicUdiDi>
    <tradeName>05902643962255</tradeName>
    <deviceName>KONTROLA CRP - Poziom 2 (1 ml)</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-812-0001</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:28:33.746Z</lastUpdated>
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    <udiDi>05902643962248</udiDi>
    <basicUdiDi>59026439CBCH811BM</basicUdiDi>
    <tradeName>05902643962248</tradeName>
    <deviceName>KONTROLA CRP - Poziom 1 (1 ml)</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-811-0001</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:28:32.932Z</lastUpdated>
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    <udiDi>05391523442367</udiDi>
    <basicUdiDi>539152344CHEM155L</basicUdiDi>
    <tradeName>Multichem MS VItD</tradeName>
    <deviceName>Multichem MS VitD</deviceName>
    <manufacturerName>Techno-path Manufacturing Ltd.</manufacturerName>
    <manufacturerSrn>IE-MF-000001822</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09922555190</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:14:36.943Z</lastUpdated>
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    <udiDi>05204309162215</udiDi>
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    <tradeName>HbA1c CONTROL</tradeName>
    <deviceName>HbA1c</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>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1578-1057</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:53:58.084Z</lastUpdated>
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    <tradeName>TOTAL ANTIOXIDANT STATUS (TAS CONTROL)</tradeName>
    <deviceName>TOTAL ANTIOXIDANT STATUS CONTROL</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
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    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NX2331</reference>
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    <lastUpdated>2026-07-01T22:44:33.021Z</lastUpdated>
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    <tradeName>Vivadiag Plus</tradeName>
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    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <reference>VOC02-011</reference>
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    <lastUpdated>2026-06-24T19:53:30.059Z</lastUpdated>
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    <tradeName>Vivadiag Plus</tradeName>
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    <tradeName>sLDL CONTROL LEVEL 2 (sLDL CONTROL 2)</tradeName>
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    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>LE5014</reference>
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    <lastUpdated>2026-06-21T18:35:27.362Z</lastUpdated>
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    <manufacturerName>Randox Laboratories Limited</manufacturerName>
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    <manufacturerName>Techno-path Manufacturing Ltd.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>09922563190</reference>
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    <lastUpdated>2026-06-20T02:37:40.127Z</lastUpdated>
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    <manufacturerName>invicon diagnostic concepts GmbH</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0101050299</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>110150</reference>
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    <lastUpdated>2026-06-18T00:43:32.033Z</lastUpdated>
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