<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-FDDDI-PN20YZ</udiDi>
    <basicUdiDi>B-FDDDI-PN20YZ</basicUdiDi>
    <tradeName>D-Dimer Control</tradeName>
    <deviceName>D-Dimer Control</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010302080501</emdnCode>
    <emdnDescription>HEMOSTASIS CONTROLS RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FDDDI-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:20:24.528Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FDDDI-PN20HG3D</udiDi>
    <basicUdiDi>B-FDDDI-PN20HG3D</basicUdiDi>
    <tradeName>D-Dimer Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010302080501</emdnCode>
    <emdnDescription>HEMOSTASIS CONTROLS RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FDDDI-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:20:20.530Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FDDDI-402aR9</udiDi>
    <basicUdiDi>B-FDDDI-402aR9</basicUdiDi>
    <tradeName>D-Dimer Quantitative Test Kit (Time-Resolved FIA)</tradeName>
    <deviceName>D-Dimer Quantitative Test Kit (Time-Resolved FIA)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FDDDI-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:20:19.723Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FDDDI-402aHGM3</udiDi>
    <basicUdiDi>B-FDDDI-402aHGM3</basicUdiDi>
    <tradeName>D-Dimer Quantitative Test Kit (Time-Resolved FIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FDDDI-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:20:18.918Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FAC-XII-P5701-010CJ</udiDi>
    <basicUdiDi>B-FAC-XII-P5701-010CJ</basicUdiDi>
    <tradeName>TEClot Factor XII Deficient Plasma</tradeName>
    <deviceName>FAC</deviceName>
    <manufacturerName>TECO Medical Instruments, Production + Trading GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000022642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020211</emdnCode>
    <emdnDescription>COAGULATION FACTOR XII</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P5701-010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:16:39.325Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FAC-XI-P5601-010A8</udiDi>
    <basicUdiDi>B-FAC-XI-P5601-010A8</basicUdiDi>
    <tradeName>TEClot Factor XI Deficient Plasma</tradeName>
    <deviceName>FAC</deviceName>
    <manufacturerName>TECO Medical Instruments, Production + Trading GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000022642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020210</emdnCode>
    <emdnDescription>COAGULATION FACTOR XI</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P5601-010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:16:36.925Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FAC-X-P5501-010EQ</udiDi>
    <basicUdiDi>B-FAC-X-P5501-010EQ</basicUdiDi>
    <tradeName>TEClot Factor X Deficient Plasma</tradeName>
    <deviceName>FAC</deviceName>
    <manufacturerName>TECO Medical Instruments, Production + Trading GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000022642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020209</emdnCode>
    <emdnDescription>COAGULATION FACTOR X</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P5501-010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:16:35.331Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FAC-VIII-P5301-01097</udiDi>
    <basicUdiDi>B-FAC-VIII-P5301-01097</basicUdiDi>
    <tradeName>TEClot Factor VIII Deficient Plasma</tradeName>
    <deviceName>FAC</deviceName>
    <manufacturerName>TECO Medical Instruments, Production + Trading GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000022642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020207</emdnCode>
    <emdnDescription>COAGULATION FACTOR VIII</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P5301-010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:16:34.519Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FAC-VII-P5201-0107B</udiDi>
    <basicUdiDi>B-FAC-VII-P5201-0107B</basicUdiDi>
    <tradeName>TEClot Factor VII Deficient Plasma</tradeName>
    <deviceName>FAC</deviceName>
    <manufacturerName>TECO Medical Instruments, Production + Trading GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000022642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020205</emdnCode>
    <emdnDescription>COAGULATION FACTOR VII</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P5201-010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:16:32.924Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FAC-V-P5101-010AN</udiDi>
    <basicUdiDi>B-FAC-V-P5101-010AN</basicUdiDi>
    <tradeName>TEClot Factor V Deficient Plasma</tradeName>
    <deviceName>FAC</deviceName>
    <manufacturerName>TECO Medical Instruments, Production + Trading GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000022642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020204</emdnCode>
    <emdnDescription>COAGULATION FACTOR V</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P5101-010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:16:29.712Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FAC-IX-P5401-0106C</udiDi>
    <basicUdiDi>B-FAC-IX-P5401-0106C</basicUdiDi>
    <tradeName>TEClot Factor IX Deficient Plasma</tradeName>
    <deviceName>FAC</deviceName>
    <manufacturerName>TECO Medical Instruments, Production + Trading GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000022642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020208</emdnCode>
    <emdnDescription>COAGULATION FACTOR IX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P5401-010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:16:28.107Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FAC-II-P5001-010ML</udiDi>
    <basicUdiDi>B-FAC-II-P5001-010ML</basicUdiDi>
    <tradeName>TEClot Factor II Deficient Plasma</tradeName>
    <deviceName>FAC</deviceName>
    <manufacturerName>TECO Medical Instruments, Production + Trading GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000022642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020202</emdnCode>
    <emdnDescription>COAGULATION FACTOR II ( PROTHROMBIN )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P5001-010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:16:27.307Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FA0013YZ</udiDi>
    <basicUdiDi>B-FA0013YZ</basicUdiDi>
    <tradeName>D-FA0013YZ</tradeName>
    <deviceName>D-Dimer test kit (Immunofluorescence)</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020803</emdnCode>
    <emdnDescription>D-DIMER - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>52027017</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:15:40.822Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL2198001BG</udiDi>
    <basicUdiDi>B-EBL2198001BG</basicUdiDi>
    <tradeName>D-EBL2198001BG</tradeName>
    <deviceName>Coagulation Quality Control Plasma (CQC)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2198001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:23:28.977Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL2197001B9</udiDi>
    <basicUdiDi>B-EBL2197001B9</basicUdiDi>
    <tradeName>D-EBL2197001B9</tradeName>
    <deviceName>Coagulation Quality Control Plasma (CQC)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2197001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:23:28.171Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL2196001B2</udiDi>
    <basicUdiDi>B-EBL2196001B2</basicUdiDi>
    <tradeName>D-EBL2196001B2</tradeName>
    <deviceName>Coagulation Quality Control Plasma (CQC)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2196001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:23:27.374Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL2195001AT</udiDi>
    <basicUdiDi>B-EBL2195001AT</basicUdiDi>
    <tradeName>D-EBL2195001AT</tradeName>
    <deviceName>Coagulation Quality Control Plasma (CQC)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2195001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:23:23.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL2194001AL</udiDi>
    <basicUdiDi>B-EBL2194001AL</basicUdiDi>
    <tradeName>D-EBL2194001AL</tradeName>
    <deviceName>Coagulation Quality Control Plasma (CQC)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2194001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:23:22.570Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL2193001AD</udiDi>
    <basicUdiDi>B-EBL2193001AD</basicUdiDi>
    <tradeName>D-EBL2193001AD</tradeName>
    <deviceName>Coagulation Quality Control Plasma (CQC)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2193001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:23:21.769Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL2192006AG</udiDi>
    <basicUdiDi>B-EBL2192006AG</basicUdiDi>
    <tradeName>D-EBL2192006AG</tradeName>
    <deviceName>D-Dimer &amp; FDP Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020799</emdnCode>
    <emdnDescription>HAEMOSTASIS CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2192006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:23:21.121Z</lastUpdated>
  </row>
</eudamedExport>