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    <tradeName>ITA Control Serum Level 3</tradeName>
    <deviceName>ITA Control Serum Level 3</deviceName>
    <manufacturerName>Beckman Coulter Ireland Inc.</manufacturerName>
    <manufacturerSrn>IE-MF-000000887</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>ODC0016</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:31:09.841Z</lastUpdated>
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    <basicUdiDi>150995902ODC00158U</basicUdiDi>
    <tradeName>ITA Control Serum Level 2</tradeName>
    <deviceName>ITA Control Serum Level 2</deviceName>
    <manufacturerName>Beckman Coulter Ireland Inc.</manufacturerName>
    <manufacturerSrn>IE-MF-000000887</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>ODC0015</reference>
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    <basicUdiDi>150995902ODC00148S</basicUdiDi>
    <tradeName>ITA Control Serum Level 1</tradeName>
    <deviceName>ITA Control Serum Level 1</deviceName>
    <manufacturerName>Beckman Coulter Ireland Inc.</manufacturerName>
    <manufacturerSrn>IE-MF-000000887</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>ODC0014</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:31:05.842Z</lastUpdated>
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    <basicUdiDi>150995902ODC00138Q</basicUdiDi>
    <tradeName>CRP (Latex) Control Serum</tradeName>
    <deviceName>CRP (Latex) Control Serum</deviceName>
    <manufacturerName>Beckman Coulter Ireland Inc.</manufacturerName>
    <manufacturerSrn>IE-MF-000000887</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152003</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ODC0013</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:31:05.046Z</lastUpdated>
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    <udiDi>62230041025544</udiDi>
    <basicUdiDi>B-62230041025544</basicUdiDi>
    <tradeName>Immunology Control Low</tradeName>
    <deviceName>Immunology Control Low</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>W01021521</emdnCode>
    <emdnDescription>MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>606 001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:07:52.869Z</lastUpdated>
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    <udiDi>06976968300992</udiDi>
    <basicUdiDi>B-06976968300992</basicUdiDi>
    <tradeName>Thyroglobulin(TG )  Control</tradeName>
    <deviceName>Thyroglobulin(TG )  Control</deviceName>
    <manufacturerName>Shenzhen Channel Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000053778</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Multiple catalogue numbers for configurable kit combinations.</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T22:35:07.248Z</lastUpdated>
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    <udiDi>06976968300985</udiDi>
    <basicUdiDi>B-06976968300985</basicUdiDi>
    <tradeName>Thyroid-Stimulating Hormone(TSH)  Control</tradeName>
    <deviceName>Thyroid-Stimulating Hormone(TSH)  Control</deviceName>
    <manufacturerName>Shenzhen Channel Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000053778</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Multiple catalogue numbers for configurable kit combinations.</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T22:35:06.998Z</lastUpdated>
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    <udiDi>06976968300978</udiDi>
    <basicUdiDi>B-06976968300978</basicUdiDi>
    <tradeName>Total Thyroxine（TT4） Control</tradeName>
    <deviceName>Total Thyroxine（TT4） Control</deviceName>
    <manufacturerName>Shenzhen Channel Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000053778</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Multiple catalogue numbers for configurable kit combinations.</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T22:35:06.958Z</lastUpdated>
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    <udiDi>06976968300961</udiDi>
    <basicUdiDi>B-06976968300961</basicUdiDi>
    <tradeName>Total Triiodothyronine（TT3） Control</tradeName>
    <deviceName>Total Triiodothyronine（TT3） Control</deviceName>
    <manufacturerName>Shenzhen Channel Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000053778</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Multiple catalogue numbers for configurable kit combinations.</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T22:35:06.879Z</lastUpdated>
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    <udiDi>06976968300954</udiDi>
    <basicUdiDi>B-06976968300954</basicUdiDi>
    <tradeName>Free Thyroxine(FT4)  Control</tradeName>
    <deviceName>Free Thyroxine(FT4)  Control</deviceName>
    <manufacturerName>Shenzhen Channel Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000053778</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Multiple catalogue numbers for configurable kit combinations.</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T22:34:59.253Z</lastUpdated>
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    <udiDi>06976968300947</udiDi>
    <basicUdiDi>B-06976968300947</basicUdiDi>
    <tradeName>Free Triiodothyronine(FT3) Control</tradeName>
    <deviceName>Free Triiodothyronine(FT3) Control</deviceName>
    <manufacturerName>Shenzhen Channel Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000053778</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Multiple catalogue numbers for configurable kit combinations.</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T22:34:58.506Z</lastUpdated>
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    <udiDi>00630414998947</udiDi>
    <basicUdiDi>0405686901436VK</basicUdiDi>
    <tradeName>IMMULITE SHBG Control Module</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_REAG_Sex hrmne-binding globulin Con Mod</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152008</emdnCode>
    <emdnDescription>CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10285226</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:52:52.072Z</lastUpdated>
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    <udiDi>84352873311205</udiDi>
    <basicUdiDi>B-84352873311205</basicUdiDi>
    <tradeName>Clonatest</tradeName>
    <deviceName>RF- Turbidimetric Calibrator</deviceName>
    <manufacturerName>Linear Chemicals S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000003284</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152210</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS FOR RHEUMATOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CT39301</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-29T08:26:05.486Z</lastUpdated>
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    <udiDi>84352873311199</udiDi>
    <basicUdiDi>B-84352873311199</basicUdiDi>
    <tradeName>Clonatest</tradeName>
    <deviceName>RF-Turbidimetric Calibrator Set</deviceName>
    <manufacturerName>Linear Chemicals S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000003284</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152210</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS FOR RHEUMATOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CT39300</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-29T08:26:04.689Z</lastUpdated>
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    <udiDi>84352873311182</udiDi>
    <basicUdiDi>B-84352873311182</basicUdiDi>
    <tradeName>Cromatest</tradeName>
    <deviceName>RF-Turbidimetric Calibrator</deviceName>
    <manufacturerName>Linear Chemicals S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000003284</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>STANDARDS AND CALIBRATORS FOR RHEUMATOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3931320</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-29T08:26:03.887Z</lastUpdated>
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    <udiDi>84352873311175</udiDi>
    <basicUdiDi>B-84352873311175</basicUdiDi>
    <tradeName>Cromatest</tradeName>
    <deviceName>RF-Turbidimetric Calibrator</deviceName>
    <manufacturerName>Linear Chemicals S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000003284</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152210</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS FOR RHEUMATOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3931305</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-29T08:25:59.884Z</lastUpdated>
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    <udiDi>84352873208116</udiDi>
    <basicUdiDi>B-84352873208116</basicUdiDi>
    <tradeName>Cromatest</tradeName>
    <deviceName>RF- Waaler Positive Control</deviceName>
    <manufacturerName>Linear Chemicals S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000003284</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152010</emdnCode>
    <emdnDescription>CONTROLS FOR RHEUMATOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2923710</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-29T08:25:45.481Z</lastUpdated>
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    <udiDi>84352873213042</udiDi>
    <basicUdiDi>B-84352873213042</basicUdiDi>
    <tradeName>Cromatest</tradeName>
    <deviceName>SLE-Latex Positive Control</deviceName>
    <manufacturerName>Linear Chemicals S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000003284</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152010</emdnCode>
    <emdnDescription>CONTROLS FOR RHEUMATOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2924310</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-29T08:25:44.684Z</lastUpdated>
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    <udiDi>06976968300930</udiDi>
    <basicUdiDi>B-06976968300930</basicUdiDi>
    <tradeName>Testosterone(TESTO)  Control</tradeName>
    <deviceName>Testosterone(TESTO)  Control</deviceName>
    <manufacturerName>Shenzhen Channel Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000053778</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Multiple catalogue numbers for configurable kit combinations.</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T08:02:33.115Z</lastUpdated>
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    <udiDi>06976968300923</udiDi>
    <basicUdiDi>B-06976968300923</basicUdiDi>
    <tradeName>Progesterone(PROG)  Control</tradeName>
    <deviceName>Progesterone(PROG)  Control</deviceName>
    <manufacturerName>Shenzhen Channel Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000053778</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Multiple catalogue numbers for configurable kit combinations.</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T08:02:32.318Z</lastUpdated>
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