<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06947145505868</udiDi>
    <basicUdiDi>B-06947145505868</basicUdiDi>
    <tradeName>MAGLUMI Anti-nRNP/Sm IgG (CLIA)</tradeName>
    <deviceName>Anti-nRNP/Sm IgG (CLIA)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100114</emdnCode>
    <emdnDescription>U1-SNRNP - ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130217011M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:18:07.498Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145505806</udiDi>
    <basicUdiDi>B-06947145505806</basicUdiDi>
    <tradeName>MAGLUMI Anti-M2-3E IgG (CLIA</tradeName>
    <deviceName>Anti-M2-3E IgG (CLIA)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100702</emdnCode>
    <emdnDescription>ANTI-MITOCHONDRIAL ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130217007M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:18:05.008Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145505516</udiDi>
    <basicUdiDi>B-06947145505516</basicUdiDi>
    <tradeName>MAGLUMI HAV IgM (CLIA)</tradeName>
    <deviceName>HAV IgM (CLIA)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020104</emdnCode>
    <emdnDescription>HAV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130210008M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:18:03.810Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145505493</udiDi>
    <basicUdiDi>B-06947145505493</basicUdiDi>
    <tradeName>MAGLUMI Anti-HAV (CLIA)</tradeName>
    <deviceName>Anti-HAV (CLIA)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020102</emdnCode>
    <emdnDescription>HAV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130210007M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:17:56.607Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145505455</udiDi>
    <basicUdiDi>B-06947145505455</basicUdiDi>
    <tradeName>MAGLUMI Chagas (CLIA)</tradeName>
    <deviceName>Chagas (CLIA)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050202</emdnCode>
    <emdnDescription>CHAGAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130219001M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:17:55.404Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145502195</udiDi>
    <basicUdiDi>B-06947145502195</basicUdiDi>
    <tradeName>MAGLUMI Pepsinogen II (CLIA)</tradeName>
    <deviceName>PG  II (CLIA)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130201020M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:17:54.208Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145502171</udiDi>
    <basicUdiDi>B-06947145502171</basicUdiDi>
    <tradeName>MAGLUMI PG I (CLIA)</tradeName>
    <deviceName>PG I (CLIA)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130201019M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:17:53.378Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145502157</udiDi>
    <basicUdiDi>B-06947145502157</basicUdiDi>
    <tradeName>MAGLUMI FK 506 (CLIA)</tradeName>
    <deviceName>FK 506 (CLIA)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080603</emdnCode>
    <emdnDescription>TACROLIMUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130207003M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:17:45.803Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145502133</udiDi>
    <basicUdiDi>B-06947145502133</basicUdiDi>
    <tradeName>MAGLUMI A Ⅱ(CLIA)</tradeName>
    <deviceName>A Ⅱ(CLIA)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060202</emdnCode>
    <emdnDescription>ANGIOTENSIN I / II</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130206006M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:17:44.616Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145502119</udiDi>
    <basicUdiDi>B-06947145502119</basicUdiDi>
    <tradeName>MAGLUMI   A Ⅰ(CLIA)</tradeName>
    <deviceName>A Ⅰ(CLIA)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060202</emdnCode>
    <emdnDescription>ANGIOTENSIN I / II</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130206005M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:17:43.401Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145501679</udiDi>
    <basicUdiDi>B-06947145501679</basicUdiDi>
    <tradeName>MAGLUMI GAD65 (CLIA)</tradeName>
    <deviceName>GAD65 (CLIA)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060105</emdnCode>
    <emdnDescription>GAD II ANTIBODIES AND OTHER ICA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130205005M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:17:42.198Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145501495</udiDi>
    <basicUdiDi>B-06947145501495</basicUdiDi>
    <tradeName>MAGLUMI   Troponin I (CLIA)</tradeName>
    <deviceName>Troponin I (CLIA)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130206002M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:17:35.003Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145501457</udiDi>
    <basicUdiDi>B-06947145501457</basicUdiDi>
    <tradeName>MAGLUMI CSA (CLIA)</tradeName>
    <deviceName>CSA (CLIA)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080601</emdnCode>
    <emdnDescription>CYCLOSPORINE TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130207001M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:17:33.800Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145501365</udiDi>
    <basicUdiDi>B-06947145501365</basicUdiDi>
    <tradeName>MAGLUMI HA (CLIA)</tradeName>
    <deviceName>HA (CLIA)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102120103</emdnCode>
    <emdnDescription>HYALURONIC ACID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130209001M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:17:32.587Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145501341</udiDi>
    <basicUdiDi>B-06947145501341</basicUdiDi>
    <tradeName>MAGLUMI C IV (CLIA)</tradeName>
    <deviceName>C IV (CLIA)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102120199</emdnCode>
    <emdnDescription>LIVER FUNCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130209003M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:17:31.389Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145501303</udiDi>
    <basicUdiDi>B-06947145501303</basicUdiDi>
    <tradeName>MAGLUMI S-100 (CLIA)</tradeName>
    <deviceName>S-100 (CLIA)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039012</emdnCode>
    <emdnDescription>PROTEIN S-100 B</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130201017M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:17:25.386Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145501044</udiDi>
    <basicUdiDi>B-06947145501044</basicUdiDi>
    <tradeName>MAGLUMI f-PSA (CLIA)</tradeName>
    <deviceName>f-PSA (CLIA)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030114</emdnCode>
    <emdnDescription>FREE PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130201005M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:17:24.202Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145500986</udiDi>
    <basicUdiDi>B-06947145500986</basicUdiDi>
    <tradeName>MAGLUMI GH (CLIA)</tradeName>
    <deviceName>GH (CLIA)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060402</emdnCode>
    <emdnDescription>HUMAN GROWTH HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130298001M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:17:22.995Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145500948</udiDi>
    <basicUdiDi>B-06947145500948</basicUdiDi>
    <tradeName>MAGLUMI β2-MG (CLIA)</tradeName>
    <deviceName>β2-MG (CLIA)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130204001M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:17:21.774Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145500689</udiDi>
    <basicUdiDi>B-06947145500689</basicUdiDi>
    <tradeName>MAGLUMI free Estriol (CLIA)</tradeName>
    <deviceName>free Estriol (CLIA)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050203</emdnCode>
    <emdnDescription>UNCONJUGATED (FREE) ESTRIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130202008M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:17:15.773Z</lastUpdated>
  </row>
</eudamedExport>