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    <basicUdiDi>B-36974969796258</basicUdiDi>
    <tradeName>Squamous Cell Carcinoma Antigen (SCC) 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>2063W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:01:25.962Z</lastUpdated>
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    <udiDi>56974969796252</udiDi>
    <basicUdiDi>B-56974969796252</basicUdiDi>
    <tradeName>Squamous Cell Carcinoma Antigen (SCC) 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>2063W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:01:25.217Z</lastUpdated>
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    <udiDi>36974969796326</udiDi>
    <basicUdiDi>B-36974969796326</basicUdiDi>
    <tradeName>Progastrin-Releasing Peptide (proGRP) 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>2064W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:01:19.717Z</lastUpdated>
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    <udiDi>56974969796320</udiDi>
    <basicUdiDi>B-56974969796320</basicUdiDi>
    <tradeName>Progastrin-Releasing Peptide (proGRP) 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>2064W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:01:17.782Z</lastUpdated>
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    <udiDi>36974969796456</udiDi>
    <basicUdiDi>B-36974969796456</basicUdiDi>
    <tradeName>Calcitonin (CT) 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>2068W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:01:17.002Z</lastUpdated>
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    <udiDi>56974969796450</udiDi>
    <basicUdiDi>B-56974969796450</basicUdiDi>
    <tradeName>Calcitonin (CT) 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>2068W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:01:16.379Z</lastUpdated>
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    <udiDi>36974969796586</udiDi>
    <basicUdiDi>B-36974969796586</basicUdiDi>
    <tradeName>Unconjugated Estriol (uE3) 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>2081W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:01:15.793Z</lastUpdated>
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    <udiDi>56974969796580</udiDi>
    <basicUdiDi>B-56974969796580</basicUdiDi>
    <tradeName>Unconjugated Estriol (uE3) 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>2081W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:01:15.001Z</lastUpdated>
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    <udiDi>36974969796623</udiDi>
    <basicUdiDi>B-36974969796623</basicUdiDi>
    <tradeName>Pregnancy-Associated Plasma Protein A (PAPP-A) 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>2082W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:01:10.409Z</lastUpdated>
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    <udiDi>56974969796627</udiDi>
    <basicUdiDi>B-56974969796627</basicUdiDi>
    <tradeName>Pregnancy-Associated Plasma Protein A (PAPP-A) 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>2082W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:01:09.687Z</lastUpdated>
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    <udiDi>36974969796753</udiDi>
    <basicUdiDi>B-36974969796753</basicUdiDi>
    <tradeName>H.Pylori IgG-CLIA</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>2092W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:01:08.881Z</lastUpdated>
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    <udiDi>56974969796757</udiDi>
    <basicUdiDi>B-56974969796757</basicUdiDi>
    <tradeName>HP IgG 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>2092W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:01:06.413Z</lastUpdated>
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  <row>
    <udiDi>36974969796883</udiDi>
    <basicUdiDi>B-36974969796883</basicUdiDi>
    <tradeName>HP Typing 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>2105W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:01:03.842Z</lastUpdated>
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    <udiDi>56974969796887</udiDi>
    <basicUdiDi>B-56974969796887</basicUdiDi>
    <tradeName>HP Typing 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>2105W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:00:58.698Z</lastUpdated>
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    <udiDi>36974969796432</udiDi>
    <basicUdiDi>B-36974969796432</basicUdiDi>
    <tradeName>Tissue Plasminogen Activator-Plasminogen Activator Inhibitor-1 Complex (tPAIC) 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>2037W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:00:57.252Z</lastUpdated>
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    <udiDi>56974969798614</udiDi>
    <basicUdiDi>B-56974969798614</basicUdiDi>
    <tradeName>Interleukin 6 (IL-6) 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>IVDD</legislation>
    <emdnCode>W01030609</emdnCode>
    <emdnDescription>INTERLEUKIN 6 (IL-6)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2006W</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:06:24.145Z</lastUpdated>
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    <udiDi>36974969798610</udiDi>
    <basicUdiDi>B-36974969798610</basicUdiDi>
    <tradeName>Interleukin 6 (IL-6) 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>IVDD</legislation>
    <emdnCode>W01030609</emdnCode>
    <emdnDescription>INTERLEUKIN 6 (IL-6)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2006W</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-11T03:43:00.657Z</lastUpdated>
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    <udiDi>16974969799989</udiDi>
    <basicUdiDi>69749697905005ET</basicUdiDi>
    <tradeName>16974969799989</tradeName>
    <deviceName>Fluorescent 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 Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0299</emdnCode>
    <emdnDescription>IVD INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-08-07T09:12:31.421Z</lastUpdated>
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    <udiDi>26974969792345</udiDi>
    <basicUdiDi>B-26974969792345</basicUdiDi>
    <tradeName>Creatine Kinase Isoenzyme MB (CK-MB) /Cardiac Troponin I (cTnI)/ Myoglobin (MYO) 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>IVDD</legislation>
    <emdnCode>W01021311</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14W</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:16:31.524Z</lastUpdated>
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    <udiDi>16974969799026</udiDi>
    <basicUdiDi>697496979AFS2G</basicUdiDi>
    <tradeName>Fluorescent Immuno analyzer</tradeName>
    <deviceName>Fluorescent Immuno 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 Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0299</emdnCode>
    <emdnDescription>IVD INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>In Vitro Diagnostic Devices Regulations(2017/746)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:50:29.265Z</lastUpdated>
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