<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-A00737SZ</udiDi>
    <basicUdiDi>B-A00737SZ</basicUdiDi>
    <tradeName>D-A00737SZ</tradeName>
    <deviceName>a-1 Microglobulin Calibrator</deviceName>
    <manufacturerName>DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.</manufacturerName>
    <manufacturerSrn>AT-MF-000000254</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152299</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A00737</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-11T20:28:16.739Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A00505SA</udiDi>
    <basicUdiDi>B-A00505SA</basicUdiDi>
    <tradeName>D-A00505SA</tradeName>
    <deviceName>a-2 Macroglobulin</deviceName>
    <manufacturerName>DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.</manufacturerName>
    <manufacturerSrn>AT-MF-000000254</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019003</emdnCode>
    <emdnDescription>A2-MACROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A00505</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-11T20:28:15.229Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A00503S6</udiDi>
    <basicUdiDi>B-A00503S6</basicUdiDi>
    <tradeName>D-A00503S6</tradeName>
    <deviceName>a-1 Microglobulin</deviceName>
    <manufacturerName>DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.</manufacturerName>
    <manufacturerSrn>AT-MF-000000254</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019004</emdnCode>
    <emdnDescription>A1-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A00503</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-11T20:28:13.540Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A00501S2</udiDi>
    <basicUdiDi>B-A00501S2</basicUdiDi>
    <tradeName>D-A00501S2</tradeName>
    <deviceName>a-1 Antitrypsin</deviceName>
    <manufacturerName>DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.</manufacturerName>
    <manufacturerSrn>AT-MF-000000254</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019002</emdnCode>
    <emdnDescription>A1-ANTITRYPSIN (PROTEASE INHIBITOR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A00501</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-11T20:28:11.953Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697566851GLUTEST01HC76</udiDi>
    <basicUdiDi>B-697566851GLUTEST01HC76</basicUdiDi>
    <tradeName>D-697566851GLUTEST01HC76</tradeName>
    <deviceName>Blood glucose Test Strips</deviceName>
    <manufacturerName>Jiangsu Jinzhun Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027592</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W0101060101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T20:28:07.966Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975068491111</udiDi>
    <basicUdiDi>B-06975068491111</basicUdiDi>
    <tradeName>06975068491111</tradeName>
    <deviceName>Fecal Occult Blood/Transferrin（FOB/TRF）Combined Test Kit（Colloidal Gold）</deviceName>
    <manufacturerName>WWHS Biotech.Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000027179</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160203</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP076.B1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-11T20:05:58.659Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975068491074</udiDi>
    <basicUdiDi>B-06975068491074</basicUdiDi>
    <tradeName>06975068491074</tradeName>
    <deviceName>Respiratory Syncytial Virus（RSV）Rapid Test Kit（Colloidal Gold）</deviceName>
    <manufacturerName>WWHS Biotech.Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000027179</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040605</emdnCode>
    <emdnDescription>RESPIRATORY SYNCYTIAL VIRUS (RSV)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP109.B1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-11T20:05:57.873Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061053152943</udiDi>
    <basicUdiDi>B-05061053152943</basicUdiDi>
    <tradeName>05061053152943</tradeName>
    <deviceName>Deben Shigella Antisera</deviceName>
    <manufacturerName>Deben Diagnostics Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023695</manufacturerSrn>
    <authorisedRepresentativeName>EU-UK Authorised Representative Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000010192</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01029001</emdnCode>
    <emdnDescription>ANTISERA (MONOVALENT AND POLYVALENT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>294913</reference>
    <placedOnMarketCountry>Luxembourg</placedOnMarketCountry>
    <lastUpdated>2026-08-11T20:05:37.868Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061053152936</udiDi>
    <basicUdiDi>B-05061053152936</basicUdiDi>
    <tradeName>05061053152936</tradeName>
    <deviceName>Deben Shigella Antisera</deviceName>
    <manufacturerName>Deben Diagnostics Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023695</manufacturerSrn>
    <authorisedRepresentativeName>EU-UK Authorised Representative Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000010192</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01029001</emdnCode>
    <emdnDescription>ANTISERA (MONOVALENT AND POLYVALENT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>294906</reference>
    <placedOnMarketCountry>Luxembourg</placedOnMarketCountry>
    <lastUpdated>2026-08-11T20:05:37.061Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061053152929</udiDi>
    <basicUdiDi>B-05061053152929</basicUdiDi>
    <tradeName>05061053152929</tradeName>
    <deviceName>Deben Shigella Antisera</deviceName>
    <manufacturerName>Deben Diagnostics Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023695</manufacturerSrn>
    <authorisedRepresentativeName>EU-UK Authorised Representative Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000010192</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01029001</emdnCode>
    <emdnDescription>ANTISERA (MONOVALENT AND POLYVALENT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>294890</reference>
    <placedOnMarketCountry>Luxembourg</placedOnMarketCountry>
    <lastUpdated>2026-08-11T20:05:36.247Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061053152912</udiDi>
    <basicUdiDi>B-05061053152912</basicUdiDi>
    <tradeName>05061053152912</tradeName>
    <deviceName>Deben Shigella Antisera</deviceName>
    <manufacturerName>Deben Diagnostics Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023695</manufacturerSrn>
    <authorisedRepresentativeName>EU-UK Authorised Representative Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000010192</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01029001</emdnCode>
    <emdnDescription>ANTISERA (MONOVALENT AND POLYVALENT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>294883</reference>
    <placedOnMarketCountry>Luxembourg</placedOnMarketCountry>
    <lastUpdated>2026-08-11T20:05:32.249Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061053152905</udiDi>
    <basicUdiDi>B-05061053152905</basicUdiDi>
    <tradeName>05061053152905</tradeName>
    <deviceName>Deben Shigella Antisera</deviceName>
    <manufacturerName>Deben Diagnostics Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023695</manufacturerSrn>
    <authorisedRepresentativeName>EU-UK Authorised Representative Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000010192</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01029001</emdnCode>
    <emdnDescription>ANTISERA (MONOVALENT AND POLYVALENT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>294876</reference>
    <placedOnMarketCountry>Luxembourg</placedOnMarketCountry>
    <lastUpdated>2026-08-11T20:05:31.462Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061053152899</udiDi>
    <basicUdiDi>B-05061053152899</basicUdiDi>
    <tradeName>05061053152899</tradeName>
    <deviceName>Deben Shigella Antisera</deviceName>
    <manufacturerName>Deben Diagnostics Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023695</manufacturerSrn>
    <authorisedRepresentativeName>EU-UK Authorised Representative Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000010192</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01029001</emdnCode>
    <emdnDescription>ANTISERA (MONOVALENT AND POLYVALENT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>294869</reference>
    <placedOnMarketCountry>Luxembourg</placedOnMarketCountry>
    <lastUpdated>2026-08-11T20:05:30.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060428440029</udiDi>
    <basicUdiDi>B-05060428440029</basicUdiDi>
    <tradeName>05060428440029</tradeName>
    <deviceName>Paracetamol Assay Kit</deviceName>
    <manufacturerName>Cambridge Life Sciences Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000026451</manufacturerSrn>
    <authorisedRepresentativeName>Glenbio Ireland Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000024936</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090201</emdnCode>
    <emdnDescription>ACETAMINOPHENE (PARACETAMOL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K8003</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-11T20:05:29.860Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0230006TT</udiDi>
    <basicUdiDi>B-0230006TT</basicUdiDi>
    <tradeName>möLab® BTM Blasentumor Test</tradeName>
    <deviceName>BTM Test</deviceName>
    <manufacturerName>möLab GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000022941</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030101</emdnCode>
    <emdnDescription>BLADDER TUMOUR ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0230006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T20:01:39.573Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FHC-RU1023J</udiDi>
    <basicUdiDi>B-FHC-RU1023J</basicUdiDi>
    <tradeName>D-FHC-RU1023J</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Acro Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017832</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FHC-RU102</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T20:00:35.124Z</lastUpdated>
  </row>
  <row>
    <udiDi>09120036860155</udiDi>
    <basicUdiDi>B-09120036860155</basicUdiDi>
    <tradeName>09120036860155</tradeName>
    <deviceName>Coagulation Control AK</deviceName>
    <manufacturerName>Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000024115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5011060</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-11T19:58:37.396Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895309673</udiDi>
    <basicUdiDi>B-06936895309673</basicUdiDi>
    <tradeName>Lactate Dehydrogenase Isozyme 1 (LDH1) Test Kit (Lactate Stroma Rate)</tradeName>
    <deviceName>Lactate Dehydrogenase Isozyme 1 (LDH1) Test Kit (Lactate Stroma Rate)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010121</emdnCode>
    <emdnDescription>LACTATE DEHYDROGENASE ISOENZYMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:25mL×4  R2:5mL×4（796）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T19:51:23.071Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895309666</udiDi>
    <basicUdiDi>B-06936895309666</basicUdiDi>
    <tradeName>Lactate Dehydrogenase Isozyme 1 (LDH1) Test Kit (Lactate Stroma Rate)</tradeName>
    <deviceName>Lactate Dehydrogenase Isozyme 1 (LDH1) Test Kit (Lactate Stroma Rate)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010121</emdnCode>
    <emdnDescription>LACTATE DEHYDROGENASE ISOENZYMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:25mL×4  R2:5mL×4（710）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T19:51:22.264Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895309635</udiDi>
    <basicUdiDi>B-06936895309635</basicUdiDi>
    <tradeName>Lactate Dehydrogenase Isozyme 1 (LDH1) Test Kit (Lactate Stroma Rate)</tradeName>
    <deviceName>Lactate Dehydrogenase Isozyme 1 (LDH1) Test Kit (Lactate Stroma Rate)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010121</emdnCode>
    <emdnDescription>LACTATE DEHYDROGENASE ISOENZYMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:50ml×2    R2:25ml×2（798）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T19:51:18.264Z</lastUpdated>
  </row>
</eudamedExport>