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    <basicUdiDi>69506174IM441265DZ</basicUdiDi>
    <tradeName>06950617402718</tradeName>
    <deviceName>Anti-PM-Scl Antibody Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100109</emdnCode>
    <emdnDescription>PM-SCL - ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4411265</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:38:33.305Z</lastUpdated>
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    <udiDi>06950617402701</udiDi>
    <basicUdiDi>69506174IM441265DZ</basicUdiDi>
    <tradeName>06950617402701</tradeName>
    <deviceName>Anti-PM-Scl Antibody Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100109</emdnCode>
    <emdnDescription>PM-SCL - ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4410265</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:38:32.107Z</lastUpdated>
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    <udiDi>06950617402695</udiDi>
    <basicUdiDi>69506174IM440256DR</basicUdiDi>
    <tradeName>06950617402695</tradeName>
    <deviceName>Anti-SSA(Ro60) antibody Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100112</emdnCode>
    <emdnDescription>SS-A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4407256</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:38:30.916Z</lastUpdated>
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    <udiDi>06950617402688</udiDi>
    <basicUdiDi>69506174IM440256DR</basicUdiDi>
    <tradeName>06950617402688</tradeName>
    <deviceName>Anti-SSA(Ro60) antibody Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100112</emdnCode>
    <emdnDescription>SS-A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4409256</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:38:29.711Z</lastUpdated>
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    <udiDi>06950617402671</udiDi>
    <basicUdiDi>69506174IM440256DR</basicUdiDi>
    <tradeName>06950617402671</tradeName>
    <deviceName>Anti-SSA(Ro60) antibody Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100112</emdnCode>
    <emdnDescription>SS-A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4403256</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:38:21.295Z</lastUpdated>
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    <udiDi>06950617402664</udiDi>
    <basicUdiDi>69506174IM440256DR</basicUdiDi>
    <tradeName>06950617402664</tradeName>
    <deviceName>Anti-SSA(Ro60) antibody Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100112</emdnCode>
    <emdnDescription>SS-A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4402256</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:38:20.580Z</lastUpdated>
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    <udiDi>06950617402657</udiDi>
    <basicUdiDi>69506174IM440263DN</basicUdiDi>
    <tradeName>06950617402657</tradeName>
    <deviceName>Anti-Nuc Antibody Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100117</emdnCode>
    <emdnDescription>NUCLEOSOME ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4407263</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:38:18.912Z</lastUpdated>
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    <udiDi>06950617402640</udiDi>
    <basicUdiDi>69506174IM440263DN</basicUdiDi>
    <tradeName>06950617402640</tradeName>
    <deviceName>Anti-Nuc Antibody Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100117</emdnCode>
    <emdnDescription>NUCLEOSOME ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4409263</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:38:16.496Z</lastUpdated>
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    <udiDi>06950617402633</udiDi>
    <basicUdiDi>69506174IM440263DN</basicUdiDi>
    <tradeName>06950617402633</tradeName>
    <deviceName>Anti-Nuc Antibody Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100117</emdnCode>
    <emdnDescription>NUCLEOSOME ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4402263</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:38:09.401Z</lastUpdated>
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    <udiDi>06950617402626</udiDi>
    <basicUdiDi>69506174IM440263DN</basicUdiDi>
    <tradeName>06950617402626</tradeName>
    <deviceName>Anti-Nuc Antibody Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100117</emdnCode>
    <emdnDescription>NUCLEOSOME ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4403263</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:38:06.975Z</lastUpdated>
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    <udiDi>06950617402619</udiDi>
    <basicUdiDi>69506174IM440258DV</basicUdiDi>
    <tradeName>06950617402619</tradeName>
    <deviceName>Anti-SSB(La) Antibody Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100113</emdnCode>
    <emdnDescription>SS-B</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4407258</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:38:05.687Z</lastUpdated>
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    <udiDi>06950617402602</udiDi>
    <basicUdiDi>69506174IM440258DV</basicUdiDi>
    <tradeName>06950617402602</tradeName>
    <deviceName>Anti-SSB(La) Antibody Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100113</emdnCode>
    <emdnDescription>SS-B</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4409258</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:38:04.505Z</lastUpdated>
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    <udiDi>06950617402596</udiDi>
    <basicUdiDi>69506174IM440258DV</basicUdiDi>
    <tradeName>06950617402596</tradeName>
    <deviceName>Anti-SSB(La) Antibody Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100113</emdnCode>
    <emdnDescription>SS-B</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4403258</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:37:53.680Z</lastUpdated>
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    <udiDi>06950617402589</udiDi>
    <basicUdiDi>69506174IM440258DV</basicUdiDi>
    <tradeName>06950617402589</tradeName>
    <deviceName>Anti-SSB(La) Antibody Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100113</emdnCode>
    <emdnDescription>SS-B</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4402258</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:37:51.276Z</lastUpdated>
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    <udiDi>06950617402572</udiDi>
    <basicUdiDi>69506174IM449268FX</basicUdiDi>
    <tradeName>06950617402572</tradeName>
    <deviceName>Rheumatoid Control Plus</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152011</emdnCode>
    <emdnDescription>CONTROLS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4491268</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:37:50.070Z</lastUpdated>
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    <udiDi>06950617402565</udiDi>
    <basicUdiDi>69506174IM449268FX</basicUdiDi>
    <tradeName>06950617402565</tradeName>
    <deviceName>Rheumatoid Control Plus</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152011</emdnCode>
    <emdnDescription>CONTROLS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4492268</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:37:48.873Z</lastUpdated>
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    <udiDi>06950617402541</udiDi>
    <basicUdiDi>69506174IM449268FX</basicUdiDi>
    <tradeName>06950617402541</tradeName>
    <deviceName>Rheumatoid Control Plus</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152011</emdnCode>
    <emdnDescription>CONTROLS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4494268</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:37:39.277Z</lastUpdated>
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    <udiDi>06950617402534</udiDi>
    <basicUdiDi>69506174IM449268FX</basicUdiDi>
    <tradeName>06950617402534</tradeName>
    <deviceName>Rheumatoid Control Plus</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152011</emdnCode>
    <emdnDescription>CONTROLS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4495268</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:37:36.878Z</lastUpdated>
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    <udiDi>06950617402480</udiDi>
    <basicUdiDi>69506174IM449051F4</basicUdiDi>
    <tradeName>06950617402480</tradeName>
    <deviceName>Thyroid Function Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4491051</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:37:34.475Z</lastUpdated>
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    <udiDi>06950617402473</udiDi>
    <basicUdiDi>69506174IM449051F4</basicUdiDi>
    <tradeName>06950617402473</tradeName>
    <deviceName>Thyroid Function Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4492051</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:37:33.284Z</lastUpdated>
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