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    <basicUdiDi>69471455456WN</basicUdiDi>
    <tradeName>MAGLUMI PAP (CLIA) Controls</tradeName>
    <deviceName>PAP (CLIA) Controls</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>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160201456MT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:52:48.854Z</lastUpdated>
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    <udiDi>06947145520984</udiDi>
    <basicUdiDi>69471455489X5</basicUdiDi>
    <tradeName>MAGLUMI β2-Microglobulin (CLIA) Controls</tradeName>
    <deviceName>β2-Microglobulin (CLIA) Controls</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>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160201489MT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:52:22.401Z</lastUpdated>
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    <udiDi>06947145515522</udiDi>
    <basicUdiDi>69471455226W3</basicUdiDi>
    <tradeName>MAGLUMI CA 242 (CLIA) Controls</tradeName>
    <deviceName>CA 242 (CLIA) Controls</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>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160201226MT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:51:48.758Z</lastUpdated>
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    <udiDi>06947145515492</udiDi>
    <basicUdiDi>69471455223VV</basicUdiDi>
    <tradeName>MAGLUMI CA 50 (CLIA) Controls</tradeName>
    <deviceName>CA 50 (CLIA) Controls</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>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160201223MT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:51:47.969Z</lastUpdated>
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  <row>
    <udiDi>06947145515348</udiDi>
    <basicUdiDi>69471455422W5</basicUdiDi>
    <tradeName>MAGLUMI HER-2 (CLIA) Controls</tradeName>
    <deviceName>HER-2 (CLIA) Controls</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>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160201422MT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:51:40.862Z</lastUpdated>
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  <row>
    <udiDi>06947145515157</udiDi>
    <basicUdiDi>69471455420VZ</basicUdiDi>
    <tradeName>MAGLUMI ProGRP (CLIA) Controls</tradeName>
    <deviceName>ProGRP (CLIA) Controls</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>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160201420MT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:51:10.286Z</lastUpdated>
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  <row>
    <udiDi>06947145523329</udiDi>
    <basicUdiDi>694714551012HK</basicUdiDi>
    <tradeName>MAGLUMI TPA (CLIA) Controls</tradeName>
    <deviceName>TPA (CLIA) Controls</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>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1602011012MT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:47:56.137Z</lastUpdated>
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  <row>
    <udiDi>06936415908867</udiDi>
    <basicUdiDi>69449040004L-TM-Con****UY</basicUdiDi>
    <tradeName>Tumor Marker Multi Control</tradeName>
    <deviceName>Tumor Marker Multi 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>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-007381-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:41:36.184Z</lastUpdated>
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  <row>
    <udiDi>06936415908218</udiDi>
    <basicUdiDi>69449040004V-TMII-Con**DV</basicUdiDi>
    <tradeName>Tumor Marker Multi Control II</tradeName>
    <deviceName>Tumor Marker Multi Control II</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>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-010146-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:41:32.965Z</lastUpdated>
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    <udiDi>14987481164458</udiDi>
    <basicUdiDi>49874814987481164390UP</basicUdiDi>
    <tradeName>μTASWako AFP-L3 Control H</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>993-61101</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T07:36:24.744Z</lastUpdated>
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    <udiDi>14987481164496</udiDi>
    <basicUdiDi>49874814987481164413UA</basicUdiDi>
    <tradeName>μTASWako DCP Control H</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>991-61401</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T07:36:24.688Z</lastUpdated>
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  <row>
    <udiDi>08806133048962</udiDi>
    <basicUdiDi>880613306006CR</basicUdiDi>
    <tradeName>Boditech iFOB Neo Control</tradeName>
    <deviceName>Boditech iFOB Neo Control</deviceName>
    <manufacturerName>Boditech Med Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000011028</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFPO-14</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T02:38:38.191Z</lastUpdated>
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  <row>
    <udiDi>06974925050867</udiDi>
    <basicUdiDi>697492505000005TC</basicUdiDi>
    <tradeName>Tumor Marker Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhengzhou Bioyuan Biotech Co. Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021426</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BYZKH0303</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:14:41.675Z</lastUpdated>
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    <udiDi>06974925050829</udiDi>
    <basicUdiDi>697492505000005TC</basicUdiDi>
    <tradeName>Tumor Marker Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhengzhou Bioyuan Biotech Co. Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021426</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BYZKH0203</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:14:40.457Z</lastUpdated>
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    <udiDi>06974925050782</udiDi>
    <basicUdiDi>697492505000005TC</basicUdiDi>
    <tradeName>Tumor Marker Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhengzhou Bioyuan Biotech Co. Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021426</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BYZKH0103</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:14:34.454Z</lastUpdated>
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    <udiDi>06974925050768</udiDi>
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    <tradeName>Tumor Marker Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhengzhou Bioyuan Biotech Co. Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021426</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BYZKH0101</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:14:33.250Z</lastUpdated>
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    <udiDi>06973880815405</udiDi>
    <basicUdiDi>697388081074PD</basicUdiDi>
    <tradeName>NSE Control</tradeName>
    <deviceName>NSE Control</deviceName>
    <manufacturerName>SHENZHEN EVER-BLUE BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000025048</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>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZCC122</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:10:06.685Z</lastUpdated>
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    <tradeName>HE4 Control</tradeName>
    <deviceName>HE4 Control</deviceName>
    <manufacturerName>SHENZHEN EVER-BLUE BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000025048</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>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZCC097</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:09:59.479Z</lastUpdated>
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    <udiDi>06973880815306</udiDi>
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    <tradeName>CA72-4 Control</tradeName>
    <deviceName>CA72-4 Control</deviceName>
    <manufacturerName>SHENZHEN EVER-BLUE BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000025048</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>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZCC096</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:09:58.276Z</lastUpdated>
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    <tradeName>proGRP Control</tradeName>
    <deviceName>proGRP Control</deviceName>
    <manufacturerName>SHENZHEN EVER-BLUE BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000025048</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>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZCC095</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:09:57.090Z</lastUpdated>
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