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    <basicUdiDi>B-26974969794172</basicUdiDi>
    <tradeName>Helicobacter Pylori (H.Pylori) Antigen 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>E8W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:41:56.965Z</lastUpdated>
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    <udiDi>56974969795934</udiDi>
    <basicUdiDi>B-56974969795934</basicUdiDi>
    <tradeName>Carbohydrate Antigen 72-4 (CA72-4) 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>2053W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:41:56.932Z</lastUpdated>
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    <udiDi>26974969794776</udiDi>
    <basicUdiDi>B-26974969794776</basicUdiDi>
    <tradeName>Helicobacter Pylori (H.Pylori) Typing 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>E9W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:41:56.795Z</lastUpdated>
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    <udiDi>36974969798979</udiDi>
    <basicUdiDi>B-36974969798979</basicUdiDi>
    <tradeName>Carbohydrate Antigen 15-3 (CA15-3) 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>2054W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:41:56.774Z</lastUpdated>
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    <udiDi>56974969798973</udiDi>
    <basicUdiDi>B-56974969798973</basicUdiDi>
    <tradeName>Carbohydrate Antigen 15-3 (CA15-3) 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>2054W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:41:56.318Z</lastUpdated>
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    <udiDi>36974969796135</udiDi>
    <basicUdiDi>B-36974969796135</basicUdiDi>
    <tradeName>Osteocalcin 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>2033W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:41:55.991Z</lastUpdated>
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    <udiDi>56974969796139</udiDi>
    <basicUdiDi>B-56974969796139</basicUdiDi>
    <tradeName>Osteocalcin 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>2033W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:41:55.915Z</lastUpdated>
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    <udiDi>36974969796265</udiDi>
    <basicUdiDi>B-36974969796265</basicUdiDi>
    <tradeName>Plasmin-α2-Plasmin Inhibitor Complex (PIC) 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>2034W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:41:38.659Z</lastUpdated>
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    <udiDi>56974969796269</udiDi>
    <basicUdiDi>B-56974969796269</basicUdiDi>
    <tradeName>Plasmin-α2-Plasmin Inhibitor Complex (PIC) 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>2034W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:41:38.231Z</lastUpdated>
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    <udiDi>36974969796395</udiDi>
    <basicUdiDi>B-36974969796395</basicUdiDi>
    <tradeName>Thrombin-Antithrombin Ⅲ complex (TAT) 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>2036W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:41:38.028Z</lastUpdated>
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    <udiDi>56974969796399</udiDi>
    <basicUdiDi>B-56974969796399</basicUdiDi>
    <tradeName>Thrombin-Antithrombin Ⅲ complex (TAT) 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>2036W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:41:35.701Z</lastUpdated>
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    <udiDi>36974969792144</udiDi>
    <basicUdiDi>B-36974969792144</basicUdiDi>
    <tradeName>N-terminal pro-Brain Natriuretic Peptide 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>01W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:41:34.071Z</lastUpdated>
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    <udiDi>56974969796436</udiDi>
    <basicUdiDi>B-56974969796436</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>2026-09-21T22:41:16.820Z</lastUpdated>
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    <udiDi>36974969796562</udiDi>
    <basicUdiDi>B-36974969796562</basicUdiDi>
    <tradeName>Fibrinogen Degradation Product (FDP) 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>2038W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:41:16.309Z</lastUpdated>
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    <udiDi>56974969796566</udiDi>
    <basicUdiDi>B-56974969796566</basicUdiDi>
    <tradeName>Fibrinogen Degradation Product (FDP) 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>2038W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:41:15.396Z</lastUpdated>
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    <udiDi>36974969796630</udiDi>
    <basicUdiDi>B-36974969796630</basicUdiDi>
    <tradeName>Thrombomodulin (TM) 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>2042W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:41:14.878Z</lastUpdated>
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    <udiDi>56974969796634</udiDi>
    <basicUdiDi>B-56974969796634</basicUdiDi>
    <tradeName>Thrombomodulin (TM) 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>2042W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:41:13.861Z</lastUpdated>
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    <udiDi>26974969793519</udiDi>
    <basicUdiDi>B-26974969793519</basicUdiDi>
    <tradeName>Influenza A/B (Flu A/B) virus antigen 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>56W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:39:56.259Z</lastUpdated>
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    <udiDi>26974969793571</udiDi>
    <basicUdiDi>B-26974969793571</basicUdiDi>
    <tradeName>Respiratory Syncytial Virus (RSV) Antigen 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>57W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:39:52.536Z</lastUpdated>
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    <udiDi>26974969793540</udiDi>
    <basicUdiDi>B-26974969793540</basicUdiDi>
    <tradeName>Adenovirus Antigen 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>58W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:39:33.292Z</lastUpdated>
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