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    <tradeName>Kemilo T3 Control</tradeName>
    <deviceName>Kemilo T3 Control</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CC017M</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:27:37.031Z</lastUpdated>
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    <udiDi>06971225935481</udiDi>
    <basicUdiDi>B-06971225935481</basicUdiDi>
    <tradeName>Kemilo T3 Control</tradeName>
    <deviceName>Kemilo T3 Control</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <udiDi>06971225935214</udiDi>
    <basicUdiDi>B-06971225935214</basicUdiDi>
    <tradeName>Kemilo Tβ-HCG Control</tradeName>
    <deviceName>Kemilo Tβ-HCG Control</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-06T09:27:29.029Z</lastUpdated>
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    <basicUdiDi>B-06971225935207</basicUdiDi>
    <tradeName>Kemilo Tβ-HCG Control</tradeName>
    <deviceName>Kemilo Tβ-HCG Control</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CC009M</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:27:28.517Z</lastUpdated>
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    <udiDi>06971225935191</udiDi>
    <basicUdiDi>B-06971225935191</basicUdiDi>
    <tradeName>Kemilo Tβ-HCG Control</tradeName>
    <deviceName>Kemilo Tβ-HCG Control</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CC009L</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:27:26.625Z</lastUpdated>
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    <udiDi>06971225935184</udiDi>
    <basicUdiDi>B-06971225935184</basicUdiDi>
    <tradeName>Kemilo PROG Control</tradeName>
    <deviceName>Kemilo PROG Control</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CC008H</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:27:24.222Z</lastUpdated>
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    <udiDi>00859110005821</udiDi>
    <basicUdiDi>B-00859110005821</basicUdiDi>
    <tradeName>VALIDATE® FERTILITY 2 Test Set</tradeName>
    <deviceName>VALIDATE® FERTILITY 2 Test Set</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029697</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>504re</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:41:44.947Z</lastUpdated>
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    <udiDi>00859110005814</udiDi>
    <basicUdiDi>B-00859110005814</basicUdiDi>
    <tradeName>VALIDATE® FERTILITY 1 Test Se</tradeName>
    <deviceName>VALIDATE® FERTILITY 1 Test Set</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029697</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>502re</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:41:41.023Z</lastUpdated>
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    <udiDi>00859110005678</udiDi>
    <basicUdiDi>B-00859110005678</basicUdiDi>
    <tradeName>VALIDATE® PROCALCITONIN Test Set</tradeName>
    <deviceName>VALIDATE® PROCALCITONIN Test Set</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029697</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>403ro</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:41:14.469Z</lastUpdated>
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    <udiDi>00859110005661</udiDi>
    <basicUdiDi>B-00859110005661</basicUdiDi>
    <tradeName>VALIDATE® PROCALCITONIN Test Set</tradeName>
    <deviceName>VALIDATE® PROCALCITONIN Test Set</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029697</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>403ab</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:41:10.484Z</lastUpdated>
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    <udiDi>00859110005081</udiDi>
    <basicUdiDi>B-00859110005081</basicUdiDi>
    <tradeName>VALIDATE® D-DIMER Test Set</tradeName>
    <deviceName>VALIDATE® D-DIMER Test Set</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029697</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>902se</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:39:20.692Z</lastUpdated>
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    <udiDi>00850011135365</udiDi>
    <basicUdiDi>B-00850011135365</basicUdiDi>
    <tradeName>VALIDATE® FERTILITY 3 Test Set</tradeName>
    <deviceName>VALIDATE® FERTILITY 3 Test Set</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029697</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>505ro</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:58:46.130Z</lastUpdated>
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    <udiDi>00850011135303</udiDi>
    <basicUdiDi>B-00850011135303</basicUdiDi>
    <tradeName>VALIDATE® FERTILITY 2 Test Set</tradeName>
    <deviceName>VALIDATE® FERTILITY 2 Test Set</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029697</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
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    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>504ab</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:58:34.133Z</lastUpdated>
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    <udiDi>00850011135297</udiDi>
    <basicUdiDi>B-00850011135297</basicUdiDi>
    <tradeName>VALIDATE® FERTILITY 1 Test Set</tradeName>
    <deviceName>VALIDATE® FERTILITY 1 Test Set</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029697</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-05T07:58:33.331Z</lastUpdated>
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    <udiDi>00850011135259</udiDi>
    <basicUdiDi>B-00850011135259</basicUdiDi>
    <tradeName>VALIDATE® PTH Test Set</tradeName>
    <deviceName>VALIDATE® PTH Test Set</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029697</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
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    <reference>303ro</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:58:27.730Z</lastUpdated>
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    <udiDi>00850011135211</udiDi>
    <basicUdiDi>B-00850011135211</basicUdiDi>
    <tradeName>VALIDATE® ACTH Test Set</tradeName>
    <deviceName>VALIDATE® ACTH Test Set</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029697</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
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    <lastUpdated>2026-07-05T07:58:20.521Z</lastUpdated>
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    <udiDi>00850011135174</udiDi>
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    <tradeName>VALIDATE® THY Test Set</tradeName>
    <deviceName>VALIDATE® THY Test Set</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029697</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>901bc</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:58:18.120Z</lastUpdated>
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    <udiDi>06974925050003</udiDi>
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    <tradeName>AMH Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhengzhou Bioyuan Biotech Co. Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021426</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <tradeName>ENA Control</tradeName>
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    <manufacturerName>SHENZHEN EVER-BLUE BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000025048</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <emdnDescription>HORMONE CONTROLS</emdnDescription>
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    <lastUpdated>2026-07-02T12:10:14.350Z</lastUpdated>
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    <tradeName>GBM IgG Control</tradeName>
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    <manufacturerName>SHENZHEN EVER-BLUE BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000025048</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-02T12:10:11.947Z</lastUpdated>
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