<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06954376012553</udiDi>
    <basicUdiDi>B-06954376012553</basicUdiDi>
    <tradeName>Insulin(INS) Chemiluminescence Quantitative Immunoassay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Leadman Biochemistry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020150</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <marketStatus>UNKNOWN</marketStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-28T12:24:06.114Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954376012546</udiDi>
    <basicUdiDi>B-06954376012546</basicUdiDi>
    <tradeName>Higher-Sensitivity C-Reactive Protein (hs-CRP)Chemiluminescence Quantitative Immunoassay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Leadman Biochemistry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020150</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01021308</emdnCode>
    <emdnDescription>HIGH-SENSITIVITY C-.REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <marketStatus>UNKNOWN</marketStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-28T12:24:05.029Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954376012539</udiDi>
    <basicUdiDi>B-06954376012539</basicUdiDi>
    <tradeName>Free Thyroxine (FT4) Chemiluminescence Quantitative Immunoassay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Leadman Biochemistry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020150</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01020402</emdnCode>
    <emdnDescription>FREE THYROXINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <marketStatus>UNKNOWN</marketStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-28T12:24:02.875Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954376012492</udiDi>
    <basicUdiDi>B-06954376012492</basicUdiDi>
    <tradeName>Cystatin C Chemiluminescence Quantitative Immunoassay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Leadman Biochemistry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020150</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <marketStatus>UNKNOWN</marketStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-28T12:24:01.700Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954376012461</udiDi>
    <basicUdiDi>B-06954376012461</basicUdiDi>
    <tradeName>Cancer Antigen (CA19-9)  Chemiluminescence Quantitative Immunoassay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Leadman Biochemistry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020150</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102030103</emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <marketStatus>UNKNOWN</marketStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-28T12:24:00.290Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954376012454</udiDi>
    <basicUdiDi>B-06954376012454</basicUdiDi>
    <tradeName>Cancer antigen (CA15-3)  Chemiluminescence Quantitative Immunoassay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Leadman Biochemistry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020150</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <marketStatus>UNKNOWN</marketStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-28T12:23:58.960Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954376012447</udiDi>
    <basicUdiDi>B-06954376012447</basicUdiDi>
    <tradeName>Cancer antigen (CA125)  Chemiluminescence Quantitative Immunoassay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Leadman Biochemistry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020150</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102030106</emdnCode>
    <emdnDescription>CANCER ANTIGEN 125</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <marketStatus>UNKNOWN</marketStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-28T12:23:57.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954376012423</udiDi>
    <basicUdiDi>B-06954376012423</basicUdiDi>
    <tradeName>Prostate Specific Antigen Assay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Leadman Biochemistry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020150</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <marketStatus>UNKNOWN</marketStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-28T12:23:56.436Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954376012416</udiDi>
    <basicUdiDi>B-06954376012416</basicUdiDi>
    <tradeName>Prolactin (PRL) Chemiluminescence Quantitative Immunoassay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Leadman Biochemistry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020150</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102050299</emdnCode>
    <emdnDescription>PREGNANCY TESTING HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <marketStatus>UNKNOWN</marketStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-28T12:23:54.424Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954376012409</udiDi>
    <basicUdiDi>B-06954376012409</basicUdiDi>
    <tradeName>Luteinizing Hormone (LH) Chemiluminescence Quantitative Immunoassay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Leadman Biochemistry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020150</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102050105</emdnCode>
    <emdnDescription>LUTEINISING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <marketStatus>UNKNOWN</marketStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-28T12:23:53.321Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954376012386</udiDi>
    <basicUdiDi>B-06954376012386</basicUdiDi>
    <tradeName>Growth hormone (GH) Chemiluminescence Quantitative Immunoassay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Leadman Biochemistry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020150</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102060402</emdnCode>
    <emdnDescription>HUMAN GROWTH HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <marketStatus>UNKNOWN</marketStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-28T12:23:51.996Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954376012379</udiDi>
    <basicUdiDi>B-06954376012379</basicUdiDi>
    <tradeName>Follicle Stimulating Hormone (FSH) Chemiluminescence Quantitative Immunoassay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Leadman Biochemistry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020150</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102050104</emdnCode>
    <emdnDescription>FOLLICLE STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <marketStatus>UNKNOWN</marketStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-28T12:23:50.905Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954376012362</udiDi>
    <basicUdiDi>B-06954376012362</basicUdiDi>
    <tradeName>Free Prostate Specific Antigen Assay kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Leadman Biochemistry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020150</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102030114</emdnCode>
    <emdnDescription>FREE PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <marketStatus>UNKNOWN</marketStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-28T12:23:49.116Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954376012355</udiDi>
    <basicUdiDi>B-06954376012355</basicUdiDi>
    <tradeName>Ferritin (FER) Chemiluminescence Quantitative Immunoassay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Leadman Biochemistry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020150</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <marketStatus>UNKNOWN</marketStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-28T12:23:47.992Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954376005586</udiDi>
    <basicUdiDi>B-06954376005586</basicUdiDi>
    <tradeName>Cortisol Assay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Leadman Biochemistry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020150</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102060203</emdnCode>
    <emdnDescription>CORTISOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <marketStatus>UNKNOWN</marketStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-28T12:23:46.868Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954376005555</udiDi>
    <basicUdiDi>B-06954376005555</basicUdiDi>
    <tradeName>High Sensitive Troponin-T（hs-cTnT）Assay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Leadman Biochemistry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020150</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <marketStatus>UNKNOWN</marketStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-28T12:23:45.536Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954376005548</udiDi>
    <basicUdiDi>B-06954376005548</basicUdiDi>
    <tradeName>High Sensitive Troponin-I（hs-cTnI）Assay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Leadman Biochemistry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020150</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <marketStatus>UNKNOWN</marketStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-28T12:23:44.433Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954376005500</udiDi>
    <basicUdiDi>B-06954376005500</basicUdiDi>
    <tradeName>Osteocalcin（OC）Assay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Leadman Biochemistry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020150</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102060311</emdnCode>
    <emdnDescription>OSTEOCALCINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <marketStatus>UNKNOWN</marketStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-28T12:23:43.080Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954376005418</udiDi>
    <basicUdiDi>B-06954376005418</basicUdiDi>
    <tradeName>Type Ⅳ Collagen（CIV）Assay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Leadman Biochemistry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020150</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102120199</emdnCode>
    <emdnDescription>LIVER FUNCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <marketStatus>UNKNOWN</marketStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-28T12:23:41.980Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954376005395</udiDi>
    <basicUdiDi>B-06954376005395</basicUdiDi>
    <tradeName>Squamous Cell Carcinoma(SCC)Assay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Leadman Biochemistry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020150</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102030116</emdnCode>
    <emdnDescription>SQUAMOUS CELL CARCINOMA ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <marketStatus>UNKNOWN</marketStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-28T12:23:40.764Z</lastUpdated>
  </row>
</eudamedExport>