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    <tradeName>Dimension Drugs of Abuse Positive Control</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_DOA Positive Control</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152009</emdnCode>
    <emdnDescription>CONTROLS FOR NARCOTICS / TOXICOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445033</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:43:01.124Z</lastUpdated>
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    <tradeName>IMMULITE Insulin Control Module</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_REAG_Insulin Control Module</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>10286614</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:42:28.288Z</lastUpdated>
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    <basicUdiDi>0405686900556VP</basicUdiDi>
    <tradeName>IMMULITE Osteocalcin Control Module</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_REAG_Osteocalcin Control Module</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>10385415</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:42:21.881Z</lastUpdated>
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    <udiDi>00630414953182</udiDi>
    <basicUdiDi>0405686901480VN</basicUdiDi>
    <tradeName>IMMULITE Free Beta HCG Control Module</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_C_REAG_Free Beta HCG Control Module</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152008</emdnCode>
    <emdnDescription>CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10385385</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:42:21.080Z</lastUpdated>
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    <udiDi>00630414953281</udiDi>
    <basicUdiDi>0405686901435VH</basicUdiDi>
    <tradeName>IMMULITE Pyrilinks-D Control Module</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_REAG_Pyrilinks-D Control Module</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>W0102152003</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10385243</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:42:19.477Z</lastUpdated>
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    <udiDi>00630414953120</udiDi>
    <basicUdiDi>0405686901474VT</basicUdiDi>
    <tradeName>IMMULITE Calcitonin Control Module</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_C_REAG_Calcitonin Control Module</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152008</emdnCode>
    <emdnDescription>CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10385383</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:42:02.621Z</lastUpdated>
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    <udiDi>00630414592305</udiDi>
    <basicUdiDi>0405686900756VZ</basicUdiDi>
    <tradeName>ADVIA Centaur anti-CCP IgG (aCCP) Master Curve Material (MCM)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_aCCP_MCM</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152010</emdnCode>
    <emdnDescription>CONTROLS FOR RHEUMATOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10699140</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:41:21.803Z</lastUpdated>
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    <udiDi>00630414245676</udiDi>
    <basicUdiDi>0405686900757W3</basicUdiDi>
    <tradeName>Atellica IM Anti-CCP IgG Quality Control (aCCP QC)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_aCCP_QC</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152010</emdnCode>
    <emdnDescription>CONTROLS FOR RHEUMATOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10732999</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:40:46.526Z</lastUpdated>
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    <udiDi>08056771201063</udiDi>
    <basicUdiDi>B-08056771201063</basicUdiDi>
    <tradeName>LIAISON® Control Ferritin</tradeName>
    <deviceName>LIAISON® Control Ferritin</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152006</emdnCode>
    <emdnDescription>ANAEMIA RELATED/VITAMIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>313552</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-22T22:40:27.557Z</lastUpdated>
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    <udiDi>08056771200899</udiDi>
    <basicUdiDi>B-08056771200899</basicUdiDi>
    <tradeName>LIAISON® Control tTG IgA</tradeName>
    <deviceName>LIAISON® Control tTG IgA</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>310321</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-22T22:40:23.554Z</lastUpdated>
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    <udiDi>08056771200554</udiDi>
    <basicUdiDi>80567713191085J</basicUdiDi>
    <tradeName>LIAISON® Control NSE</tradeName>
    <deviceName>LIAISON® Control NSE</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>319108</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-22T22:40:22.175Z</lastUpdated>
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    <udiDi>08056771200578</udiDi>
    <basicUdiDi>B-08056771200578</basicUdiDi>
    <tradeName>LIAISON® Control S100</tradeName>
    <deviceName>LIAISON® Control S100</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>319112</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-22T22:40:19.542Z</lastUpdated>
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    <udiDi>08056771103626</udiDi>
    <basicUdiDi>80567713113213U</basicUdiDi>
    <tradeName>LIAISON® Control PSA II Gen</tradeName>
    <deviceName>LIAISON® Control PSA II Gen</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>311321</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-22T22:39:40.218Z</lastUpdated>
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    <udiDi>08056771101318</udiDi>
    <basicUdiDi>805677131804154</basicUdiDi>
    <tradeName>LIAISON® Control BRAHMS PCT® II GEN</tradeName>
    <deviceName>LIAISON® Control BRAHMS PCT® II GEN</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152008</emdnCode>
    <emdnDescription>CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>318041</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-22T22:39:33.002Z</lastUpdated>
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    <udiDi>06976968300916</udiDi>
    <basicUdiDi>B-06976968300916</basicUdiDi>
    <tradeName>Estradiol(E2) Control</tradeName>
    <deviceName>Estradiol(E2) 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>2026-07-22T20:58:32.982Z</lastUpdated>
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    <udiDi>06976968300909</udiDi>
    <basicUdiDi>B-06976968300909</basicUdiDi>
    <tradeName>Prolactin(PRL) Control</tradeName>
    <deviceName>Prolactin(PRL) 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>2026-07-22T20:58:32.185Z</lastUpdated>
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    <udiDi>06976968300893</udiDi>
    <basicUdiDi>B-06976968300893</basicUdiDi>
    <tradeName>Follicle Stimulating Hormone(FSH) Control</tradeName>
    <deviceName>Follicle Stimulating Hormone(FSH) 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>2026-07-22T20:58:28.188Z</lastUpdated>
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    <udiDi>06976968300886</udiDi>
    <basicUdiDi>B-06976968300886</basicUdiDi>
    <tradeName>Luteinizing Hormone(LH) Control</tradeName>
    <deviceName>Luteinizing Hormone(LH) 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>2026-07-22T20:58:27.388Z</lastUpdated>
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    <udiDi>06976968300879</udiDi>
    <basicUdiDi>B-06976968300879</basicUdiDi>
    <tradeName>β Human Chorionic Gonadotropin(β-HCG) Control</tradeName>
    <deviceName>β Human Chorionic Gonadotropin(β-HCG) 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>CR064EU01-CR064EU16</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:58:26.573Z</lastUpdated>
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    <udiDi>84352873300193</udiDi>
    <basicUdiDi>B-84352873300193</basicUdiDi>
    <tradeName>Cromatest</tradeName>
    <deviceName>ASLO-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>W0102152010</emdnCode>
    <emdnDescription>CONTROLS FOR RHEUMATOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3931105</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:54:06.274Z</lastUpdated>
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