<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06954376005425</udiDi>
    <basicUdiDi>B-06954376005425</basicUdiDi>
    <tradeName>Laminin（LN）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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <marketStatus>UNKNOWN</marketStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-30T02:32:45.936Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954376005494</udiDi>
    <basicUdiDi>B-06954376005494</basicUdiDi>
    <tradeName>Interleukin-6（IL-6）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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <marketStatus>UNKNOWN</marketStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-30T02:32:45.904Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954376012331</udiDi>
    <basicUdiDi>B-06954376012331</basicUdiDi>
    <tradeName>α1-fetoprotein AFP 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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <marketStatus>UNKNOWN</marketStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-30T02:32:45.867Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954376005203</udiDi>
    <basicUdiDi>69543760F0003266</basicUdiDi>
    <tradeName>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>2026-05-29T17:00:14.404Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954376005326</udiDi>
    <basicUdiDi>B-06954376005326</basicUdiDi>
    <tradeName>Anti-Mueller Hormones（AMH）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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <marketStatus>UNKNOWN</marketStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-29T17:00:14.369Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954376005562</udiDi>
    <basicUdiDi>B-06954376005562</basicUdiDi>
    <tradeName>High Sensitive Thyrotropin（hs-TSH）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>W01020410</emdnCode>
    <emdnDescription>THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <marketStatus>UNKNOWN</marketStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-29T09:51:00.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954376005524</udiDi>
    <basicUdiDi>B-06954376005524</basicUdiDi>
    <tradeName>Pepsinogen Ⅱ（PGⅡ）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>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <marketStatus>UNKNOWN</marketStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-29T09:50:59.189Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954376005517</udiDi>
    <basicUdiDi>B-06954376005517</basicUdiDi>
    <tradeName>Pepsinogen Ⅰ（PGⅠ）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>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <marketStatus>UNKNOWN</marketStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-29T09:50:57.408Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954376012614</udiDi>
    <basicUdiDi>B-06954376012614</basicUdiDi>
    <tradeName>Thyroxine (T4) 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>W01020407</emdnCode>
    <emdnDescription>THYROXINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <marketStatus>UNKNOWN</marketStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-28T12:24:11.975Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954376012591</udiDi>
    <basicUdiDi>B-06954376012591</basicUdiDi>
    <tradeName>Testosterone(T) 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>W0102050110</emdnCode>
    <emdnDescription>TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <marketStatus>UNKNOWN</marketStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-28T12:24:10.422Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954376012584</udiDi>
    <basicUdiDi>B-06954376012584</basicUdiDi>
    <tradeName>Procalcitonin(PCT) 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>W0102069013</emdnCode>
    <emdnDescription>PROCALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <marketStatus>UNKNOWN</marketStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-28T12:24:09.296Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954376012577</udiDi>
    <basicUdiDi>B-06954376012577</basicUdiDi>
    <tradeName>Progesterone (P) 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>W0102050106</emdnCode>
    <emdnDescription>PROGESTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <marketStatus>UNKNOWN</marketStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-28T12:24:08.188Z</lastUpdated>
  </row>
  <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>
</eudamedExport>