<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06944904048291</udiDi>
    <basicUdiDi>69449040004H-t-PSA*****H9</basicUdiDi>
    <tradeName>Total PSA Calibrators</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102030113</emdnCode>
    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004288-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:29.925Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770024321302</udiDi>
    <basicUdiDi>B-03770024321302</basicUdiDi>
    <tradeName>03770024321302</tradeName>
    <deviceName>PSA-RIACT</deviceName>
    <manufacturerName>Cisbio Bioassays</manufacturerName>
    <manufacturerSrn>FR-MF-000024051</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSA-RIACT</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:31:57.636Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806133043585</udiDi>
    <basicUdiDi>880613300133BP</basicUdiDi>
    <tradeName>ichroma™ PSA Neo</tradeName>
    <deviceName>ichroma™ PSA Neo</deviceName>
    <manufacturerName>Boditech Med Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000011028</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFPC-157</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:38:51.933Z</lastUpdated>
  </row>
  <row>
    <udiDi>06939716404410</udiDi>
    <basicUdiDi>69713904301037D</basicUdiDi>
    <tradeName>HOKAPI™ PSA</tradeName>
    <deviceName>HOKAPI™ PSA</deviceName>
    <manufacturerName>Suzhou Hokapi Biomedical Engineering Co., Ltd..</manufacturerName>
    <manufacturerSrn>CN-MF-000013723</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010103001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:54:32.586Z</lastUpdated>
  </row>
  <row>
    <udiDi>06926802606445</udiDi>
    <basicUdiDi>69268026MD771T000000001H7</basicUdiDi>
    <tradeName>06926802606445</tradeName>
    <deviceName>Total PSA (CLIA)</deviceName>
    <manufacturerName>MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000005925</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCL10701E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:41:14.596Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973864382404</udiDi>
    <basicUdiDi>6978364380097GB</basicUdiDi>
    <tradeName>06973864382404</tradeName>
    <deviceName>Total Prostate Specific Antigen (PSA) (Light-initiated Chemiluminescence Immunoassay, LiCA)</deviceName>
    <manufacturerName>Chemclin Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009729</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12010107823</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:09:10.244Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973864382398</udiDi>
    <basicUdiDi>6978364380097GB</basicUdiDi>
    <tradeName>06973864382398</tradeName>
    <deviceName>Total Prostate Specific Antigen (PSA) (Light-initiated Chemiluminescence Immunoassay, LiCA)</deviceName>
    <manufacturerName>Chemclin Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009729</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12010107821</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:09:09.032Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973864382381</udiDi>
    <basicUdiDi>6978364380097GB</basicUdiDi>
    <tradeName>06973864382381</tradeName>
    <deviceName>Total Prostate Specific Antigen (PSA) (Light-initiated Chemiluminescence Immunoassay, LiCA)</deviceName>
    <manufacturerName>Chemclin Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009729</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12010107822</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:09:07.846Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973864382374</udiDi>
    <basicUdiDi>6978364380097GB</basicUdiDi>
    <tradeName>06973864382374</tradeName>
    <deviceName>Total Prostate Specific Antigen (PSA) (Light-initiated Chemiluminescence Immunoassay, LiCA)</deviceName>
    <manufacturerName>Chemclin Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009729</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12010107820</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:09:01.845Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973600799992</udiDi>
    <basicUdiDi>697360079022JR</basicUdiDi>
    <tradeName>INNODX T-PSA CMIA</tradeName>
    <deviceName>INNODX T-PSA CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-T-PSA-01100</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:06:36.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973600799879</udiDi>
    <basicUdiDi>697360079022JR</basicUdiDi>
    <tradeName>INNODX T-PSA CMIA</tradeName>
    <deviceName>INNODX T-PSA CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-T-PSA-02100</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:06:35.343Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973600799862</udiDi>
    <basicUdiDi>697360079022JR</basicUdiDi>
    <tradeName>INNODX T-PSA CMIA</tradeName>
    <deviceName>INNODX T-PSA CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-T-PSA-0250</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:06:34.131Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973600799855</udiDi>
    <basicUdiDi>697360079022JR</basicUdiDi>
    <tradeName>INNODX T-PSA CMIA</tradeName>
    <deviceName>INNODX T-PSA CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-T-PSA-01200</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:06:28.122Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973600799848</udiDi>
    <basicUdiDi>697360079022JR</basicUdiDi>
    <tradeName>INNODX T-PSA CMIA</tradeName>
    <deviceName>INNODX T-PSA CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-T-PSA-0150</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:06:26.930Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971390434987</udiDi>
    <basicUdiDi>69713904301037D</basicUdiDi>
    <tradeName>HOKAPI™ PSA</tradeName>
    <deviceName>HOKAPI™ PSA</deviceName>
    <manufacturerName>Suzhou Hokapi Biomedical Engineering Co., Ltd..</manufacturerName>
    <manufacturerSrn>CN-MF-000013723</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010103101</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:01:27.902Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970341685508</udiDi>
    <basicUdiDi>69703416803205053JG</basicUdiDi>
    <tradeName>Total Prostate Specific Antigen (eCLIA)</tradeName>
    <deviceName>Total Prostate Specific Antigen (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320501104</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:56:37.070Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970341685492</udiDi>
    <basicUdiDi>69703416803205053JG</basicUdiDi>
    <tradeName>Total Prostate Specific Antigen (eCLIA)</tradeName>
    <deviceName>Total Prostate Specific Antigen (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320501103</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:56:34.667Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970341685485</udiDi>
    <basicUdiDi>69703416803205053JG</basicUdiDi>
    <tradeName>Total Prostate Specific Antigen (eCLIA)</tradeName>
    <deviceName>Total Prostate Specific Antigen (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320501102</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:56:33.467Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970341685478</udiDi>
    <basicUdiDi>69703416803205053JG</basicUdiDi>
    <tradeName>Total Prostate Specific Antigen (eCLIA)</tradeName>
    <deviceName>Total Prostate Specific Antigen (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320501101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:56:31.070Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970150908294</udiDi>
    <basicUdiDi>697015090000111GS</basicUdiDi>
    <tradeName>tPSA CLIA Microparticles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMB0302</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:47:15.933Z</lastUpdated>
  </row>
</eudamedExport>