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    <tradeName>IMMULITE 2000 Gelatin (porcine) Specific Allergen</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_REAG_Gelatin (porcine) Spfc Algn</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>
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    <emdnDescription>IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10639219</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:02:24.316Z</lastUpdated>
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    <basicUdiDi>0405686901412V5</basicUdiDi>
    <tradeName>IMMULITE 2000 Total T3</tradeName>
    <deviceName></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>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020405</emdnCode>
    <emdnDescription>TRIIODOTHYRONINE</emdnDescription>
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    <tradeName>IMMULITE 2000 Prolactin</tradeName>
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    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <udiDi>00630414962320</udiDi>
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    <tradeName>IMMULITE 2000 Vitamin B12</tradeName>
    <deviceName></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>W0102070204</emdnCode>
    <emdnDescription>VITAMIN B12</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10380913</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:45:18.004Z</lastUpdated>
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    <udiDi>00630414238425</udiDi>
    <basicUdiDi>0405686901464VQ</basicUdiDi>
    <tradeName>Atellica IM Thyroglobulin (Tg)</tradeName>
    <deviceName></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>W01020408</emdnCode>
    <emdnDescription>THYROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11200534</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:45:06.605Z</lastUpdated>
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    <udiDi>00630414962184</udiDi>
    <basicUdiDi>0405686901408VE</basicUdiDi>
    <tradeName>IMMULITE 2000 Third Generation TSH</tradeName>
    <deviceName></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>W01020410</emdnCode>
    <emdnDescription>THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10381667</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T03:46:08.738Z</lastUpdated>
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    <udiDi>00630414246994</udiDi>
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    <tradeName>Atellica IM Multi-Diluent 14</tradeName>
    <deviceName></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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11200662</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:50:58.397Z</lastUpdated>
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    <basicUdiDi>0405686901473VR</basicUdiDi>
    <tradeName>IMMULITE 2000 Unconjugated Estriol</tradeName>
    <deviceName></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>W0102050203</emdnCode>
    <emdnDescription>UNCONJUGATED (FREE) ESTRIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10381192</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:44:59.265Z</lastUpdated>
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    <tradeName>IMMULITE 2000 Total IgE</tradeName>
    <deviceName></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>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10380872</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:44:59.023Z</lastUpdated>
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    <udiDi>00630414245386</udiDi>
    <basicUdiDi>0405686901418VH</basicUdiDi>
    <tradeName>ADVIA Centaur  aTgII Master Curve Material (aTgII MCM)</tradeName>
    <deviceName></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>W0102152011</emdnCode>
    <emdnDescription>CONTROLS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11200352</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T03:46:21.796Z</lastUpdated>
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    <udiDi>00630414972886</udiDi>
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    <tradeName>IMMULITE 2000 Multi-Diluent 2</tradeName>
    <deviceName></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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010114</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IG'S)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10283031</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T12:36:09.167Z</lastUpdated>
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    <udiDi>00630414245324</udiDi>
    <basicUdiDi>0405686901371VG</basicUdiDi>
    <tradeName>Atellica IM Anti-Thyroglobulin II (aTgII)</tradeName>
    <deviceName></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>W0102100303</emdnCode>
    <emdnDescription>THYROGLOBULIN AUTOANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11201761</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T13:35:39.536Z</lastUpdated>
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    <udiDi>00630414245355</udiDi>
    <basicUdiDi>0405686901371VG</basicUdiDi>
    <tradeName>ADVIA Centaur  Anti-Thyroglobulin II (aTgII)</tradeName>
    <deviceName></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>W0102100303</emdnCode>
    <emdnDescription>THYROGLOBULIN AUTOANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11201758</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T13:35:39.501Z</lastUpdated>
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    <udiDi>00630414245362</udiDi>
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    <tradeName>ADVIA Centaur  Anti-Thyroglobulin II (aTgII)</tradeName>
    <deviceName></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>W0102100303</emdnCode>
    <emdnDescription>THYROGLOBULIN AUTOANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11201760</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T13:35:39.490Z</lastUpdated>
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    <udiDi>00630414245379</udiDi>
    <basicUdiDi>0405686901419VK</basicUdiDi>
    <tradeName>ADVIA Centaur  aTgII Quality Control (aTgII QC)</tradeName>
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    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152011</emdnCode>
    <emdnDescription>CONTROLS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11202552</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T13:35:39.476Z</lastUpdated>
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    <basicUdiDi>0405686901459VX</basicUdiDi>
    <tradeName>Atellica IM NT-proBNP (PBNP)</tradeName>
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    <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>W01021301</emdnCode>
    <emdnDescription>BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11201891</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T13:35:39.351Z</lastUpdated>
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    <tradeName>ADVIA Centaur  NT-proBNP (PBNP)</tradeName>
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    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>11201874</reference>
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    <lastUpdated>2026-06-22T13:35:39.329Z</lastUpdated>
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    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
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    <emdnDescription>BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11201875</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
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    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11200237</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T13:35:39.227Z</lastUpdated>
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    <tradeName>Atellica IM PlGF Quality Control (PlGF QC)</tradeName>
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    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11200234</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T13:35:39.185Z</lastUpdated>
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