<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-6-33A9</udiDi>
    <basicUdiDi>B-6-33A9</basicUdiDi>
    <tradeName>D-6-33A9</tradeName>
    <deviceName>Antistreptolysin O Test Kit (Immunoturbidimetric Assay)</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021105</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O REACTION TIME / TITRE (QUALITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: U87682040M-2, U87689060M, U87685020M, U87611020M-2, U87620060M-2"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:12:39.302Z</lastUpdated>
  </row>
  <row>
    <udiDi>62230041006048</udiDi>
    <basicUdiDi>B-62230041006048</basicUdiDi>
    <tradeName>Antistreptolysin O Titre (ASOT)</tradeName>
    <deviceName>Antistreptolysin O Titre (ASOT)</deviceName>
    <manufacturerName>Egyptian Company For Biotechnology-Spectrum Diagnostics</manufacturerName>
    <manufacturerSrn>EG-MF-000032599</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021105</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O REACTION TIME / TITRE (QUALITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>510 002</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:11:58.730Z</lastUpdated>
  </row>
  <row>
    <udiDi>62230041005980</udiDi>
    <basicUdiDi>B-62230041005980</basicUdiDi>
    <tradeName>Antistreptolysin O Titre (ASOT)</tradeName>
    <deviceName>Antistreptolysin O Titre (ASOT)</deviceName>
    <manufacturerName>Egyptian Company For Biotechnology-Spectrum Diagnostics</manufacturerName>
    <manufacturerSrn>EG-MF-000032599</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021105</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O REACTION TIME / TITRE (QUALITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>510 001</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:11:55.081Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ASOT-28</udiDi>
    <basicUdiDi>B-ASOT-28</basicUdiDi>
    <tradeName>ASOT</tradeName>
    <deviceName>ASOT</deviceName>
    <manufacturerName>NS BIOTEC</manufacturerName>
    <manufacturerSrn>EG-MF-000032515</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021105</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O REACTION TIME / TITRE (QUALITATIVE)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>Aso-Ma-050L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:44:40.879Z</lastUpdated>
  </row>
  <row>
    <udiDi>8053617720184</udiDi>
    <basicUdiDi>B-8053617720184</basicUdiDi>
    <tradeName>ASO Latex Slide</tradeName>
    <deviceName>ASO Latex Slide</deviceName>
    <manufacturerName>MTD Diagnostics srl</manufacturerName>
    <manufacturerSrn>IT-MF-000053242</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021105</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O REACTION TIME / TITRE (QUALITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RT1010</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:32:24.873Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-084360385635639GT</udiDi>
    <basicUdiDi>B-084360385635639GT</basicUdiDi>
    <tradeName>Anti Streptolysin-O (ASO), 5 mL Latex, 1 mL Positive control, 1 mL Negative control</tradeName>
    <deviceName>Anti Streptolysin-O (ASO), 5 mL Latex, 1 mL Positive control, 1 mL Negative control</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021105</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O REACTION TIME / TITRE (QUALITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0216</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:29:23.840Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-084360385525526FM</udiDi>
    <basicUdiDi>B-084360385525526FM</basicUdiDi>
    <tradeName>ASO Latex, 1 x 5 mL</tradeName>
    <deviceName>ASO Latex, 1 x 5 mL</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021105</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O REACTION TIME / TITRE (QUALITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0190</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:29:19.036Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053172971397</udiDi>
    <basicUdiDi>B-08053172971397</basicUdiDi>
    <tradeName>ASO Slide</tradeName>
    <deviceName>ASO Slide</deviceName>
    <manufacturerName>GIESSE DIAGNOSTICS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000039031</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021105</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O REACTION TIME / TITRE (QUALITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7787</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:46:06.086Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053172971380</udiDi>
    <basicUdiDi>B-08053172971380</basicUdiDi>
    <tradeName>ASO Slide</tradeName>
    <deviceName>ASO Slide</deviceName>
    <manufacturerName>GIESSE DIAGNOSTICS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000039031</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021105</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O REACTION TIME / TITRE (QUALITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7702</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:46:02.088Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053172971366</udiDi>
    <basicUdiDi>B-08053172971366</basicUdiDi>
    <tradeName>ASO Slide</tradeName>
    <deviceName>ASO Slide</deviceName>
    <manufacturerName>GIESSE DIAGNOSTICS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000039031</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021105</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O REACTION TIME / TITRE (QUALITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7701</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:46:01.281Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260658551071</udiDi>
    <basicUdiDi>B-04260658551071</basicUdiDi>
    <tradeName>Atlas ASO Latex , 100 Tests</tradeName>
    <deviceName>Atlas ASO Latex Kit , 100 Tests</deviceName>
    <manufacturerName>Atlas Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000029961</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021105</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O REACTION TIME / TITRE (QUALITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8.00.02.0.0100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:53:35.978Z</lastUpdated>
  </row>
  <row>
    <udiDi>08426950457305</udiDi>
    <basicUdiDi>84269504573058F</basicUdiDi>
    <tradeName>rheumajet ASO</tradeName>
    <deviceName>rheumajet ASO</deviceName>
    <manufacturerName>Biokit S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000002406</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021105</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O REACTION TIME / TITRE (QUALITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000-7010</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:05:05.145Z</lastUpdated>
  </row>
  <row>
    <udiDi>05902643958883</udiDi>
    <basicUdiDi>59026439BRTL901QD</basicUdiDi>
    <tradeName>05902643958883</tradeName>
    <deviceName>ASO lateks bez kontr 100 ozn</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021105</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O REACTION TIME / TITRE (QUALITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-901-1001</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:27:48.048Z</lastUpdated>
  </row>
  <row>
    <udiDi>05902643958890</udiDi>
    <basicUdiDi>59026439BRTL901QD</basicUdiDi>
    <tradeName>05902643958890</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01021105</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O REACTION TIME / TITRE (QUALITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-901-1002</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:12:34.010Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260658554904</udiDi>
    <basicUdiDi>B-04260658554904</basicUdiDi>
    <tradeName>Atlas ASO Latex with buffer, 100 Tests</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atlas Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000029961</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01021105</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O REACTION TIME / TITRE (QUALITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8.00.03.0.0100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T00:35:46.280Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260658554898</udiDi>
    <basicUdiDi>B-04260658554898</basicUdiDi>
    <tradeName>Atlas ASO Latex with Buffer , 50 Tests</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atlas Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000029961</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01021105</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O REACTION TIME / TITRE (QUALITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8.00.03.0.0050</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T00:35:45.378Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260658551064</udiDi>
    <basicUdiDi>B-04260658551064</basicUdiDi>
    <tradeName>Atlas ASO Latex Kit, 50 Tests.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atlas Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000029961</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01021105</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O REACTION TIME / TITRE (QUALITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8.00.02.0.0050</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T00:33:59.517Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260658550777</udiDi>
    <basicUdiDi>B-04260658550777</basicUdiDi>
    <tradeName>Atlas ASO Latex Reagent, 5 ml/Vial, Individually Packed, 1 Vial /Box.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atlas Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000029961</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01021105</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O REACTION TIME / TITRE (QUALITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8.00.02.0.0005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T00:33:53.215Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260658550579</udiDi>
    <basicUdiDi>B-04260658550579</basicUdiDi>
    <tradeName>Atlas ASO Latex , 4 ml/Vial</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atlas Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000029961</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01021105</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O REACTION TIME / TITRE (QUALITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8.00.02.0.0004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T00:33:37.915Z</lastUpdated>
  </row>
</eudamedExport>