<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-ITE-R402SQ4A</udiDi>
    <basicUdiDi>B-ITE-R402SQ4A</basicUdiDi>
    <tradeName>Tetanus Rapid Test Cassette</tradeName>
    <deviceName>Tetanus Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011709</emdnCode>
    <emdnDescription>TETANUS (CLOSTRIDIUM T.)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITE-R402SQ</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:30:22.696Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITE-402TM</udiDi>
    <basicUdiDi>B-ITE-402TM</basicUdiDi>
    <tradeName>Tetanus Rapid Test Cassette</tradeName>
    <deviceName>Tetanus Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011709</emdnCode>
    <emdnDescription>TETANUS (CLOSTRIDIUM T.)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITE-402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:30:20.290Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IBA-402JX</udiDi>
    <basicUdiDi>B-IBA-402JX</basicUdiDi>
    <tradeName>Brucella Abortus Antigen Rapid Test Cassette</tradeName>
    <deviceName>Brucella Abortus Antigen Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011701</emdnCode>
    <emdnDescription>BRUCELLA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IBA-402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-27T22:05:27.606Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R1501522</udiDi>
    <basicUdiDi>B-R1501522</basicUdiDi>
    <tradeName>D-R1501522</tradeName>
    <deviceName>N-Terminal pro B‑type Natriuretic Peptide (NT-proBNP) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011799</emdnCode>
    <emdnDescription>BACTERIOLOGY IMMUNOASSAY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R15015</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:02:35.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R15014ZV</udiDi>
    <basicUdiDi>B-R15014ZV</basicUdiDi>
    <tradeName>D-R15014ZV</tradeName>
    <deviceName>N-Terminal pro B‑type Natriuretic Peptide (NT-proBNP) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011799</emdnCode>
    <emdnDescription>BACTERIOLOGY IMMUNOASSAY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R15014</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:02:35.124Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R15013ZT</udiDi>
    <basicUdiDi>B-R15013ZT</basicUdiDi>
    <tradeName>D-R15013ZT</tradeName>
    <deviceName>N-Terminal pro B‑type Natriuretic Peptide (NT-proBNP) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011799</emdnCode>
    <emdnDescription>BACTERIOLOGY IMMUNOASSAY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R15013</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:02:34.327Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R15012ZR</udiDi>
    <basicUdiDi>B-R15012ZR</basicUdiDi>
    <tradeName>D-R15012ZR</tradeName>
    <deviceName>N-Terminal pro B‑type Natriuretic Peptide (NT-proBNP) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011799</emdnCode>
    <emdnDescription>BACTERIOLOGY IMMUNOASSAY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R15012</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:02:30.234Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ISH-625UX</udiDi>
    <basicUdiDi>B-ISH-625UX</basicUdiDi>
    <tradeName>Shigella Rapid Test Cassette</tradeName>
    <deviceName>Shigella Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011714</emdnCode>
    <emdnDescription>SHIGELLA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISH-625</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-20T03:35:49.981Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCBP-502aOGKF</udiDi>
    <basicUdiDi>B-GCBP-502aOGKF</basicUdiDi>
    <tradeName>Bordetella Pertussis Antigen Rapid Test Kit (Colloidal Gold)</tradeName>
    <deviceName>Bordetella Pertussis Antigen Rapid Test Kit (Colloidal Gold)</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>W0105011707</emdnCode>
    <emdnDescription>BORDETELLA PERTUSSIS / PARAPERTUSSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCBP-502a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T20:40:37.901Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITE-R402HE</udiDi>
    <basicUdiDi>B-ITE-R402HE</basicUdiDi>
    <tradeName>Tetanus Rapid Test Cassette</tradeName>
    <deviceName>Tetanus Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011709</emdnCode>
    <emdnDescription>TETANUS (CLOSTRIDIUM T.)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITE-R402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:04:33.711Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ISHS-R602HN</udiDi>
    <basicUdiDi>B-ISHS-R602HN</basicUdiDi>
    <tradeName>Shigella Sonnei Antigen Rapid Test Cassette</tradeName>
    <deviceName>Shigella Sonnei Antigen Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011714</emdnCode>
    <emdnDescription>SHIGELLA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISHS-R602</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:04:20.042Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ISHF-R602CD</udiDi>
    <basicUdiDi>B-ISHF-R602CD</basicUdiDi>
    <tradeName>Shigella Flexneri Antigen Rapid Test Cassette</tradeName>
    <deviceName>Shigella Flexneri Antigen Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011714</emdnCode>
    <emdnDescription>SHIGELLA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISHF-R602</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:04:18.533Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ISH-R625JS</udiDi>
    <basicUdiDi>B-ISH-R625JS</basicUdiDi>
    <tradeName>Shigella Rapid Test Cassette</tradeName>
    <deviceName>Shigella Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011714</emdnCode>
    <emdnDescription>SHIGELLA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISH-R625</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:04:17.647Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A044D3</udiDi>
    <basicUdiDi>B-A044D3</basicUdiDi>
    <tradeName>D-A044D3</tradeName>
    <deviceName>INDICAID™ Pertussis Rapid Antibody Test</deviceName>
    <manufacturerName>Phase Scientific International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000025791</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011707</emdnCode>
    <emdnDescription>BORDETELLA PERTUSSIS / PARAPERTUSSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INDICAID™ Pertussis Rapid Antibody Test</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:42:46.597Z</lastUpdated>
  </row>
  <row>
    <udiDi>69743840313154</udiDi>
    <basicUdiDi>B-69743840313154</basicUdiDi>
    <tradeName>Typhus IgG/IgM Rapid Test (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Typhus IgG/IgM Rapid Test (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>Zhejiang Anji Saianfu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045029</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011705</emdnCode>
    <emdnDescription>RICKETTSIA</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3025201</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:13:18.502Z</lastUpdated>
  </row>
  <row>
    <udiDi>69743840311006</udiDi>
    <basicUdiDi>B-69743840311006</basicUdiDi>
    <tradeName>Brucellosis Antibody（Brucella Ab）Rapid Test</tradeName>
    <deviceName>Brucellosis Antibody（Brucella Ab）Rapid Test</deviceName>
    <manufacturerName>Zhejiang Anji Saianfu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045029</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011701</emdnCode>
    <emdnDescription>BRUCELLA</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3024901</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:12:32.339Z</lastUpdated>
  </row>
  <row>
    <udiDi>69743840310252</udiDi>
    <basicUdiDi>B-69743840310252</basicUdiDi>
    <tradeName>Leptospira IgG IgM Rapid Test</tradeName>
    <deviceName>Leptospira IgG IgM Rapid Test</deviceName>
    <manufacturerName>Zhejiang Anji Saianfu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045029</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011704</emdnCode>
    <emdnDescription>LEPTOSPIRA</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3023201</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:12:14.590Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69509960ABPTS02XHQ3</udiDi>
    <basicUdiDi>B-69509960ABPTS02XHQ3</basicUdiDi>
    <tradeName>D-69509960ABPTS02XHQ3</tradeName>
    <deviceName>Bordetella Pertussis Detection Kit (Fluorescence PCR)</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>W0105011707</emdnCode>
    <emdnDescription>BORDETELLA PERTUSSIS / PARAPERTUSSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABPTS02-AOG48E/ ABPTS02-AOG96E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:52:16.901Z</lastUpdated>
  </row>
  <row>
    <udiDi>62230182718268</udiDi>
    <basicUdiDi>B-62230182718268</basicUdiDi>
    <tradeName>Rose Bengal Brucella Antigen</tradeName>
    <deviceName>Rose Bengal Brucella Antigen</deviceName>
    <manufacturerName>Kalians Corporation</manufacturerName>
    <manufacturerSrn>EG-MF-000050142</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011701</emdnCode>
    <emdnDescription>BRUCELLA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-803 002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:37:30.863Z</lastUpdated>
  </row>
  <row>
    <udiDi>62230182718190</udiDi>
    <basicUdiDi>B-62230182718190</basicUdiDi>
    <tradeName>Rose Bengal Brucella Antigen</tradeName>
    <deviceName>Rose Bengal Brucella Antigen</deviceName>
    <manufacturerName>Kalians Corporation</manufacturerName>
    <manufacturerSrn>EG-MF-000050142</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011701</emdnCode>
    <emdnDescription>BRUCELLA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-803 001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:37:29.772Z</lastUpdated>
  </row>
</eudamedExport>