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    <basicUdiDi>B-36974969798573</basicUdiDi>
    <tradeName>Anti-TPO Test Kit (CLIA Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chongqing iSIA BIO-Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003364</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2091W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:32:17.637Z</lastUpdated>
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    <udiDi>56974969798577</udiDi>
    <basicUdiDi>B-56974969798577</basicUdiDi>
    <tradeName>Anti-TPO Test Kit (CLIA Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chongqing iSIA BIO-Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003364</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2091W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:32:17.099Z</lastUpdated>
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    <udiDi>26974969792147</udiDi>
    <basicUdiDi>B-26974969792147</basicUdiDi>
    <tradeName>N-terminal pro-Brain Natriuretic Peptide Rapid Test Kit (QDs Immunofluorescence Method)</tradeName>
    <deviceName>The Immunoassay Analyzer</deviceName>
    <manufacturerName>Chongqing iSIA BIO-Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003364</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160704</emdnCode>
    <emdnDescription>BNP / PROBNP - RT &amp; POC (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01W</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:03:16.519Z</lastUpdated>
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    <udiDi>36974969790164</udiDi>
    <basicUdiDi>69749697901002DR</basicUdiDi>
    <tradeName>Troponin I (cTnI) Rapid Test Kit (QDs Immunofluorescence Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chongqing iSIA BIO-Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003364</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>02W cTnI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:02:13.136Z</lastUpdated>
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    <udiDi>26974969792246</udiDi>
    <basicUdiDi>B-26974969792246</basicUdiDi>
    <tradeName>Troponin I Rapid Test Kit (QDs Immunofluorescence Method)</tradeName>
    <deviceName>The Immunoassay Analyzer</deviceName>
    <manufacturerName>Chongqing iSIA BIO-Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003364</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160703</emdnCode>
    <emdnDescription>TROPONIN I/T - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>02W</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:02:02.694Z</lastUpdated>
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    <udiDi>36974969792243</udiDi>
    <basicUdiDi>B-36974969792243</basicUdiDi>
    <tradeName>Troponin I Rapid Test Kit (QDs Immunofluorescence Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chongqing iSIA BIO-Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003364</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>02W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:02:01.814Z</lastUpdated>
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    <udiDi>36974969796739</udiDi>
    <basicUdiDi>B-36974969796739</basicUdiDi>
    <tradeName>Pepsinogen I (PG I) Test Kit (CLIA Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chongqing iSIA BIO-Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003364</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2001W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:01:48.681Z</lastUpdated>
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    <udiDi>56974969796733</udiDi>
    <basicUdiDi>B-56974969796733</basicUdiDi>
    <tradeName>Pepsinogen I (PG I) Test Kit (CLIA Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chongqing iSIA BIO-Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003364</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2001W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:01:48.131Z</lastUpdated>
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    <udiDi>36974969796869</udiDi>
    <basicUdiDi>B-36974969796869</basicUdiDi>
    <tradeName>Pepsinogen II (PG II) Test Kit (CLIA Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chongqing iSIA BIO-Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003364</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2002W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:01:47.152Z</lastUpdated>
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    <udiDi>56974969796863</udiDi>
    <basicUdiDi>B-56974969796863</basicUdiDi>
    <tradeName>Pepsinogen II (PG II) Test Kit (CLIA Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chongqing iSIA BIO-Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003364</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2002W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:01:41.171Z</lastUpdated>
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    <udiDi>36974969796593</udiDi>
    <basicUdiDi>B-36974969796593</basicUdiDi>
    <tradeName>Gastrin-17 Test Kit (CLIA Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chongqing iSIA BIO-Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003364</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2003W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:01:40.202Z</lastUpdated>
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    <udiDi>56974969796535</udiDi>
    <basicUdiDi>B-56974969796535</basicUdiDi>
    <tradeName>Gastrin-17 Test Kit (CLIA Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chongqing iSIA BIO-Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003364</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2003W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:01:38.346Z</lastUpdated>
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    <udiDi>36974969796760</udiDi>
    <basicUdiDi>B-36974969796760</basicUdiDi>
    <tradeName>Myeloperoxidase (MPO) Test Kit (CLIA Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chongqing iSIA BIO-Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003364</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2044W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:01:37.261Z</lastUpdated>
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    <udiDi>56974969796764</udiDi>
    <basicUdiDi>B-56974969796764</basicUdiDi>
    <tradeName>Myeloperoxidase (MPO) Test Kit (CLIA Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chongqing iSIA BIO-Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003364</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2044W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:01:36.780Z</lastUpdated>
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    <udiDi>36974969796890</udiDi>
    <basicUdiDi>B-36974969796890</basicUdiDi>
    <tradeName>Human Epididymis Protein 4 (HE4) Test Kit (CLIA Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chongqing iSIA BIO-Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003364</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2056W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:01:35.980Z</lastUpdated>
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    <udiDi>56974969796894</udiDi>
    <basicUdiDi>B-56974969796894</basicUdiDi>
    <tradeName>Human Epididymis Protein 4 (HE4) Test Kit (CLIA Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chongqing iSIA BIO-Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003364</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2056W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:01:31.942Z</lastUpdated>
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    <udiDi>36974969796937</udiDi>
    <basicUdiDi>B-36974969796937</basicUdiDi>
    <tradeName>Carbohydrate Antigen 242 (CA242) Test Kit (CLIA Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chongqing iSIA BIO-Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003364</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2057W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:01:31.505Z</lastUpdated>
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    <udiDi>56974969796931</udiDi>
    <basicUdiDi>B-56974969796931</basicUdiDi>
    <tradeName>Carbohydrate Antigen 242 (CA242) Test Kit (CLIA Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chongqing iSIA BIO-Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003364</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2057W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:01:30.751Z</lastUpdated>
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    <udiDi>36974969796128</udiDi>
    <basicUdiDi>B-36974969796128</basicUdiDi>
    <tradeName>Neuron-Specific Enolase (NSE) Test Kit (CLIA Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chongqing iSIA BIO-Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003364</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2062W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:01:28.189Z</lastUpdated>
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    <udiDi>56974969796122</udiDi>
    <basicUdiDi>B-56974969796122</basicUdiDi>
    <tradeName>Neuron-Specific Enolase (NSE) Test Kit (CLIA Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chongqing iSIA BIO-Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003364</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2062W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:01:26.737Z</lastUpdated>
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