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    <tradeName>K-ASSAY Apo AI/B Control</tradeName>
    <deviceName>Apo AI/B Control</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>K310C-4M</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
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    <tradeName>K-ASSAY Beta-2 Microglobulin/Ferritin - Serum/Plasma Control</tradeName>
    <deviceName>Beta-2 Microglobulin / Ferritin - Serum / Plasma Control</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
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    <reference>K283C-4M</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
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    <tradeName>Multi Control Cardiac Marker II</tradeName>
    <deviceName>Multi Control Cardiac Marker II</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>CARDIAC MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:04:01.467Z</lastUpdated>
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    <udiDi>06947145555382</udiDi>
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    <tradeName>MAGLUMI Anti-ZnT8 (CLIA) Controls</tradeName>
    <deviceName>Anti-ZnT8 (CLIA)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152003</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1602011085MT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:42:33.146Z</lastUpdated>
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    <udiDi>06936415900762</udiDi>
    <basicUdiDi>69449040004S-PCT*******M3</basicUdiDi>
    <tradeName>PCT Control</tradeName>
    <deviceName>Procalcitonin(CLIA)、PCT Calibrators、PCT Control</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</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>105-010248-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:37:09.346Z</lastUpdated>
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    <udiDi>05055273219036</udiDi>
    <basicUdiDi>50552732BAVB12C173QK</basicUdiDi>
    <tradeName>ACTIVE VITAMIN B12 CONTROL LEVEL 2 (Active Vitamin B12 CONTROL 2)</tradeName>
    <deviceName>ACTIVE VITAMIN B12 CONTROL</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152006</emdnCode>
    <emdnDescription>ANAEMIA RELATED/VITAMIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VB10525</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:46:50.060Z</lastUpdated>
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    <udiDi>14987481164489</udiDi>
    <basicUdiDi>49874814987481164413UA</basicUdiDi>
    <tradeName>μTASWako DCP Control L</tradeName>
    <deviceName>μTASWako DCP, μTASWako DCP Calibrator Set, μTASWako DCP Control L, μTASWako DCP Control H</deviceName>
    <manufacturerName>FUJIFILM Wako Pure Chemical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000013944</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Wako Chemicals Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011552</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>995-61301</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:42:58.968Z</lastUpdated>
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    <tradeName>μTASWako AFP-L3 Control L</tradeName>
    <deviceName>μTASWako AFP-L3, μTASWako AFP-L3 Calibrator Set, μTASWako AFP-L3 Control L, μTASWako AFP-L3 Control H</deviceName>
    <manufacturerName>FUJIFILM Wako Pure Chemical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000013944</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Wako Chemicals Europe GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>997-61001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:42:55.264Z</lastUpdated>
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    <udiDi>04987595302107</udiDi>
    <basicUdiDi>4987595PF0221CWJ</basicUdiDi>
    <tradeName>PATHFAST B･R･A･H･M･S PCT Control</tradeName>
    <deviceName>PATHFAST B·R·A·H·M·S PCT Control</deviceName>
    <manufacturerName>PHC Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000008516</manufacturerSrn>
    <authorisedRepresentativeName>PHC Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002692</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30210</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:41:02.998Z</lastUpdated>
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    <udiDi>04987595302008</udiDi>
    <basicUdiDi>4987595PF0201CW8</basicUdiDi>
    <tradeName>PATHFAST Presepsin Control</tradeName>
    <deviceName>PATHFAST Presepsin Control</deviceName>
    <manufacturerName>PHC Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000008516</manufacturerSrn>
    <authorisedRepresentativeName>PHC Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002692</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30200</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:41:02.691Z</lastUpdated>
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    <udiDi>04719879495010</udiDi>
    <basicUdiDi>471987949E103057S</basicUdiDi>
    <tradeName>DNlite uPTM-FetA ELISA Kit – Standard</tradeName>
    <deviceName>DNlite uPTM-FetA ELISA Kit – Standard</deviceName>
    <manufacturerName>Bio Preventive Medicine Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000022845</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152299</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8105002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:32:49.250Z</lastUpdated>
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    <udiDi>04719879495003</udiDi>
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    <tradeName>DNlite uPTM-FetA ELISA Kit - Controls</tradeName>
    <deviceName>DNlite uPTM-FetA ELISA Kit - Controls</deviceName>
    <manufacturerName>Bio Preventive Medicine Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000022845</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8105001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:32:44.791Z</lastUpdated>
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    <udiDi>00858724003209</udiDi>
    <basicUdiDi>0858724003MTX026AJ7</basicUdiDi>
    <tradeName>ARK Methotrexate Dilution Buffer</tradeName>
    <deviceName>ARK Methotrexate Dilution Buffer</deviceName>
    <manufacturerName>ARK Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152201</emdnCode>
    <emdnDescription>TDM/DRUG STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5026-0004-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:42:59.309Z</lastUpdated>
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    <basicUdiDi>0856743007MDI02406D</basicUdiDi>
    <tradeName>00856743007062</tradeName>
    <deviceName>Mycophenolic Acid Control</deviceName>
    <manufacturerName>More Diagnostics Inc</manufacturerName>
    <manufacturerSrn>US-MF-000019469</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-16T03:41:35.988Z</lastUpdated>
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    <deviceName>Cyclosporine C2 Control</deviceName>
    <manufacturerName>More Diagnostics Inc</manufacturerName>
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    <lastUpdated>2026-07-16T03:41:19.938Z</lastUpdated>
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    <tradeName>ARK Methotrexate II Dilution Buffer</tradeName>
    <deviceName>ARK Methotrexate II Dilution Buffer</deviceName>
    <manufacturerName>ARK Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>TDM/DRUG STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Reference Number</reference>
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    <lastUpdated>2026-07-16T03:38:33.331Z</lastUpdated>
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    <tradeName>Ethyl Glucuronide 200 Control Set</tradeName>
    <deviceName>Ethyl Glucuronide Calibrators and Controls</deviceName>
    <manufacturerName>Lin-Zhi International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003373</manufacturerSrn>
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    <emdnDescription>CONTROLS FOR NARCOTICS / TOXICOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09976507190</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:33:29.957Z</lastUpdated>
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    <tradeName>Buprenorphine 5 Qualitative Calibrator Set</tradeName>
    <deviceName>Buprenorphine Calibrators and Controls</deviceName>
    <manufacturerName>Lin-Zhi International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003373</manufacturerSrn>
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    <emdnDescription>DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS</emdnDescription>
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    <reference>08356661190</reference>
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    <lastUpdated>2026-07-16T03:33:28.356Z</lastUpdated>
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    <tradeName>Fentanyl Qualitative Calibrator Set</tradeName>
    <deviceName>Fentanyl Calibrators and Controls</deviceName>
    <manufacturerName>Lin-Zhi International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003373</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>09330097190</reference>
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    <lastUpdated>2026-07-16T03:33:26.478Z</lastUpdated>
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    <tradeName>6-Acetylmorphine Semi-Quantitative Calibrators Set</tradeName>
    <deviceName>6-Acetylmorphine Calibrators and Controls</deviceName>
    <manufacturerName>Lin-Zhi International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003373</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
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    <reference>08240183190</reference>
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    <lastUpdated>2026-07-16T03:33:12.298Z</lastUpdated>
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