<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08056771103282</udiDi>
    <basicUdiDi>B-08056771103282</basicUdiDi>
    <tradeName>LIAISON® QuantiFERON®-TB Gold Plus</tradeName>
    <deviceName>LIAISON® QuantiFERON®-TB Gold Plus</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010799</emdnCode>
    <emdnDescription>MYCOBACTERIA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>311010</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-22T22:39:34.630Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITY-4012J</udiDi>
    <basicUdiDi>B-ITY-4012J</basicUdiDi>
    <tradeName>Typhoid Rapid Test Dipstick</tradeName>
    <deviceName>Typhoid Rapid Test Dipstick</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>W0105011002</emdnCode>
    <emdnDescription>SALMONELLA ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITY-401</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:49:56.326Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITY-3022F</udiDi>
    <basicUdiDi>B-ITY-3022F</basicUdiDi>
    <tradeName>Typhoid Rapid Test Cassette</tradeName>
    <deviceName>Typhoid 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>W0105011002</emdnCode>
    <emdnDescription>SALMONELLA ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITY-302</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:49:52.317Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R179163X</udiDi>
    <basicUdiDi>B-R179163X</basicUdiDi>
    <tradeName>D-R179163X</tradeName>
    <deviceName>Treponema Pallidum Antibody (Anti-TP) 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>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R17916</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:06:20.770Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R179153V</udiDi>
    <basicUdiDi>B-R179153V</basicUdiDi>
    <tradeName>D-R179153V</tradeName>
    <deviceName>Treponema Pallidum Antibody (Anti-TP) 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>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R17915</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:06:16.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R179143T</udiDi>
    <basicUdiDi>B-R179143T</basicUdiDi>
    <tradeName>D-R179143T</tradeName>
    <deviceName>Treponema Pallidum Antibody (Anti-TP) 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>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R17914</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:06:15.072Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R179133R</udiDi>
    <basicUdiDi>B-R179133R</basicUdiDi>
    <tradeName>D-R179133R</tradeName>
    <deviceName>Treponema Pallidum Antibody (Anti-TP) 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>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R17913</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:06:14.504Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R179123P</udiDi>
    <basicUdiDi>B-R179123P</basicUdiDi>
    <tradeName>D-R179123P</tradeName>
    <deviceName>Treponema Pallidum Antibody (Anti-TP) 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>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R17912</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:06:13.480Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R179113M</udiDi>
    <basicUdiDi>B-R179113M</basicUdiDi>
    <tradeName>D-R179113M</tradeName>
    <deviceName>Treponema Pallidum Antibody (Anti-TP) 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>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R17911</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:06:09.463Z</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-IHP-607T6</udiDi>
    <basicUdiDi>B-IHP-607T6</basicUdiDi>
    <tradeName>H.pylori Antigen Rapid Test</tradeName>
    <deviceName>H.pylori Antigen Rapid Test</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>W0105010401</emdnCode>
    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHP-607</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:37:17.605Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IHP-602SU</udiDi>
    <basicUdiDi>B-IHP-602SU</basicUdiDi>
    <tradeName>H.pylori Antigen Rapid Test Cassette</tradeName>
    <deviceName>H.pylori 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>W0105010401</emdnCode>
    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHP-602</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:37:16.801Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IHP-601SS</udiDi>
    <basicUdiDi>B-IHP-601SS</basicUdiDi>
    <tradeName>H  pylori Antigen Rapid Test Dipstick</tradeName>
    <deviceName>H  pylori Antigen Rapid Test Dipstick</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>W0105010401</emdnCode>
    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHP-601</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:37:12.029Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ICDG-R602Z3</udiDi>
    <basicUdiDi>B-ICDG-R602Z3</basicUdiDi>
    <tradeName>Clostridium difficile GDH Rapid Test Cassette</tradeName>
    <deviceName>Clostridium difficile GDH 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>W0105011801</emdnCode>
    <emdnDescription>C.DIFFICILE GDH DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICDG-R602</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:37:02.392Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ICD-R635BWB</udiDi>
    <basicUdiDi>B-ICD-R635BWB</basicUdiDi>
    <tradeName>Clostridium difficile GDH+ Toxin A +Toxin B Combo Rapid Test Cassette</tradeName>
    <deviceName>Clostridium difficile GDH+ Toxin A +Toxin B Combo 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>W0105011803</emdnCode>
    <emdnDescription>C.DIFFICILE GDH AND TOXIN A/B COMBINED DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICD-R635B</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:36:58.391Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FI-HP-602SZ</udiDi>
    <basicUdiDi>B-FI-HP-602SZ</basicUdiDi>
    <tradeName>H.pylori Antigen Test Cassette</tradeName>
    <deviceName>H.pylori Antigen 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>W0105010401</emdnCode>
    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FI-HP-602</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:36:56.788Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IHP-R602FT</udiDi>
    <basicUdiDi>B-IHP-R602FT</basicUdiDi>
    <tradeName>H.pylori Antigen Rapid Test Cassette</tradeName>
    <deviceName>H.pylori 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>W0105010401</emdnCode>
    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHP-R602</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:42:59.927Z</lastUpdated>
  </row>
</eudamedExport>