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    <deviceName>Anti-β2-Glycoprotein 1 (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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152011</emdnCode>
    <emdnDescription>CONTROLS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160201442MT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:54:03.377Z</lastUpdated>
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    <tradeName>MAGLUMI Anti-Cardiolipin (CLIA) Controls</tradeName>
    <deviceName>Anti-Cardiolipin (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>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>CONTROLS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:54:02.572Z</lastUpdated>
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    <udiDi>06947145583835</udiDi>
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    <tradeName>MAGLUMI Anti-Cardiolipin IgA (CLIA) Controls</tradeName>
    <deviceName>Anti-Cardiolipin IgA (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>
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    <emdnCode>W0102152011</emdnCode>
    <emdnDescription>CONTROLS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-02T07:54:00.953Z</lastUpdated>
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    <udiDi>06947145580926</udiDi>
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    <tradeName>MAGLUMI Vitamin B12 (CLIA) Controls</tradeName>
    <deviceName>Vitamin B12 (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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152006</emdnCode>
    <emdnDescription>ANAEMIA RELATED/VITAMIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1602011044MT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:53:56.951Z</lastUpdated>
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    <udiDi>06947145580605</udiDi>
    <basicUdiDi>69471455485WV</basicUdiDi>
    <tradeName>MAGLUMI Tacrolimus (CLIA) Controls</tradeName>
    <deviceName>Tacrolimus (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>W0102152001</emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1602011036MT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:53:56.142Z</lastUpdated>
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    <udiDi>06947145575434</udiDi>
    <basicUdiDi>69471455439WN</basicUdiDi>
    <tradeName>MAGLUMI Anti-β2-Glycoprotein 1 IgA (CLIA) Controls</tradeName>
    <deviceName>Anti-β2-Glycoprotein 1 IgA (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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>CONTROLS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160201439MT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:53:55.358Z</lastUpdated>
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    <udiDi>06947145565343</udiDi>
    <basicUdiDi>69471455403VZ</basicUdiDi>
    <tradeName>MAGLUMI Anti-Dengue Virus IgM (CLIA) Controls</tradeName>
    <deviceName>Anti-Dengue Virus IgM (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>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160201403MT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:53:52.173Z</lastUpdated>
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    <udiDi>06947145565336</udiDi>
    <basicUdiDi>69471455402VX</basicUdiDi>
    <tradeName>MAGLUMI Anti-Dengue Virus IgG (CLIA) Controls</tradeName>
    <deviceName>Anti-Dengue Virus IgG (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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160201402MT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:53:51.355Z</lastUpdated>
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    <udiDi>06947145565039</udiDi>
    <basicUdiDi>69471455446WK</basicUdiDi>
    <tradeName>MAGLUMI Anti-DGP IgG (CLIA) Controls</tradeName>
    <deviceName>Anti-DGP IgG (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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152011</emdnCode>
    <emdnDescription>CONTROLS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160201446MT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:53:49.752Z</lastUpdated>
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    <udiDi>06947145564919</udiDi>
    <basicUdiDi>69471455443WD</basicUdiDi>
    <tradeName>MAGLUMI Anti-tissue Transglutaminase IgA (CLIA) Controls</tradeName>
    <deviceName>Anti-tissue Transglutaminase IgA (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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152011</emdnCode>
    <emdnDescription>CONTROLS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160201443MT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:53:45.746Z</lastUpdated>
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    <udiDi>06947145561765</udiDi>
    <basicUdiDi>69471455477WW</basicUdiDi>
    <tradeName>MAGLUMI CMV IgG (CLIA) Controls</tradeName>
    <deviceName>CMV IgG (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>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160201477MT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:53:45.066Z</lastUpdated>
  </row>
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    <udiDi>06947145564995</udiDi>
    <basicUdiDi>69471455445WH</basicUdiDi>
    <tradeName>MAGLUMI Anti-DGP IgA (CLIA) Controls</tradeName>
    <deviceName>Anti-DGP IgA (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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152011</emdnCode>
    <emdnDescription>CONTROLS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160201445MT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:53:43.336Z</lastUpdated>
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    <udiDi>06947145564957</udiDi>
    <basicUdiDi>69471455444WF</basicUdiDi>
    <tradeName>MAGLUMI Anti-tissue Transglutaminase IgG (CLIA) Controls</tradeName>
    <deviceName>Anti-tissue Transglutaminase IgG (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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152011</emdnCode>
    <emdnDescription>CONTROLS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160201444MT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:53:42.530Z</lastUpdated>
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    <udiDi>06947145561727</udiDi>
    <basicUdiDi>69471455476WU</basicUdiDi>
    <tradeName>MAGLUMI Toxo IgG (CLIA) Controls</tradeName>
    <deviceName>Toxo IgG (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>W0105080805</emdnCode>
    <emdnDescription>PARASITOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160201476MT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:53:24.896Z</lastUpdated>
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    <udiDi>06947145548322</udiDi>
    <basicUdiDi>694714551052HX</basicUdiDi>
    <tradeName>MAGLUMI Androstenedione (CLIA) Controls</tradeName>
    <deviceName>Androstenedione (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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1602011052MT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:53:24.079Z</lastUpdated>
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    <udiDi>06947145547806</udiDi>
    <basicUdiDi>69471455279WQ</basicUdiDi>
    <tradeName>MAGLUMI Coxsackievirus B IgM (CLIA)</tradeName>
    <deviceName>Coxsackievirus B IgM (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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040602</emdnCode>
    <emdnDescription>ENTEROVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130619021M</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:53:23.272Z</lastUpdated>
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    <udiDi>06947145547714</udiDi>
    <basicUdiDi>694714553513JU</basicUdiDi>
    <tradeName>Hemolumi Bead</tradeName>
    <deviceName>Bead</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020185</emdnCode>
    <emdnDescription>COAGULOMETERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>750106000201</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:53:22.481Z</lastUpdated>
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    <udiDi>06947145547707</udiDi>
    <basicUdiDi>69471455278WN</basicUdiDi>
    <tradeName>MAGLUMI Adenovirus IgM (CLIA)</tradeName>
    <deviceName>Adenovirus IgM (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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040601</emdnCode>
    <emdnDescription>ADENOVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130619020M</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:53:18.469Z</lastUpdated>
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    <basicUdiDi>694714553512JS</basicUdiDi>
    <tradeName>Hemolumi Cuvette</tradeName>
    <deviceName>Cuvette</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020185</emdnCode>
    <emdnDescription>COAGULOMETERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>750102000101</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:53:17.673Z</lastUpdated>
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    <udiDi>06947145547622</udiDi>
    <basicUdiDi>69471455277WL</basicUdiDi>
    <tradeName>MAGLUMI Respiratory Syncytial Virus IgM (CLIA) Controls</tradeName>
    <deviceName>Respiratory Syncytial Virus IgM (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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160201277MT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:53:16.868Z</lastUpdated>
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