<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>
  <row>
    <udiDi>06954376005388</udiDi>
    <basicUdiDi>B-06954376005388</basicUdiDi>
    <tradeName>Neuron-specific Enolase(NSE)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>W0102039007</emdnCode>
    <emdnDescription>NEURON SPECIFIC ENOLASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <marketStatus>UNKNOWN</marketStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-28T12:23:39.429Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954376005364</udiDi>
    <basicUdiDi>B-06954376005364</basicUdiDi>
    <tradeName>Troponin-I（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>2026-05-28T12:23:38.292Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954376005296</udiDi>
    <basicUdiDi>B-06954376005296</basicUdiDi>
    <tradeName>Cytokeratin Fragment 19（CYFRA21-1)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>W0102030111</emdnCode>
    <emdnDescription>CYFRA 21-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <marketStatus>UNKNOWN</marketStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-28T12:23:37.115Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954376005289</udiDi>
    <basicUdiDi>B-06954376005289</basicUdiDi>
    <tradeName>Cancer Antigen CA72-4 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>W0102030105</emdnCode>
    <emdnDescription>CANCER ANTIGEN 72-4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <marketStatus>UNKNOWN</marketStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-28T12:23:35.953Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954376005173</udiDi>
    <basicUdiDi>69543760Y00002DL</basicUdiDi>
    <tradeName>CI 2000S Automated Chemiluminescence Immunoassay Analyzer</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 Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <marketStatus>UNKNOWN</marketStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-27T12:02:31.013Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954376005180</udiDi>
    <basicUdiDi>69543760Y00001DJ</basicUdiDi>
    <tradeName>CI 1200 Automated Chemiluminescence Immunoassay Analyzer</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 Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <marketStatus>UNKNOWN</marketStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-27T12:02:30.994Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954376005210</udiDi>
    <basicUdiDi>69543760F0003368</basicUdiDi>
    <tradeName>Concentrated Wash Solution</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 Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <marketStatus>UNKNOWN</marketStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-27T12:02:30.965Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954376005227</udiDi>
    <basicUdiDi>69543760F000346A</basicUdiDi>
    <tradeName>Sample Diluent 1</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 Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <marketStatus>UNKNOWN</marketStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-27T12:02:30.945Z</lastUpdated>
  </row>
</eudamedExport>