<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-ECH01013144V</udiDi>
    <basicUdiDi>B-ECH01013144V</basicUdiDi>
    <tradeName>D-ECH01013144V</tradeName>
    <deviceName>Anti-Streptolysin O (ASO)</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>W01021104</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O (QUANTITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0101314</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:34:46.827Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ASO601CJ</udiDi>
    <basicUdiDi>B-ASO601CJ</basicUdiDi>
    <tradeName>Antistreptolysin O Reagent Kit</tradeName>
    <deviceName>Antistreptolysin O Reagent Kit</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021104</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O (QUANTITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASO6011Y, ASO6012Y, ASO6013Y, ASO6014Y, ASO6015Y, ASO6011N, ASO6012N, ASO6013N, ASO6014N, ASO6015N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:44:39.743Z</lastUpdated>
  </row>
  <row>
    <udiDi>80536177201772B</udiDi>
    <basicUdiDi>B-80536177201772B</basicUdiDi>
    <tradeName>ASO Latex + Calibrator</tradeName>
    <deviceName>ASO Latex + Calibrator</deviceName>
    <manufacturerName>MTD Diagnostics srl</manufacturerName>
    <manufacturerSrn>IT-MF-000053242</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021104</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O (QUANTITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB1000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:32:18.943Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-469165RD</udiDi>
    <basicUdiDi>B-469165RD</basicUdiDi>
    <tradeName>Antistreptolysin-O Reagent (ASO- 2 x 100)</tradeName>
    <deviceName>Antistreptolysin-O Reagent (ASO- 2 x 100)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021104</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O (QUANTITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>469165</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:54:19.510Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-128H50TSC5U</udiDi>
    <basicUdiDi>B-128H50TSC5U</basicUdiDi>
    <tradeName>Anti-Streptolysin O (ASO) Assay Kit (Latex-enhanced Immunoturbidimetric Method)</tradeName>
    <deviceName>Anti-Streptolysin O (ASO) Assay Kit (Latex-enhanced Immunoturbidimetric Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021104</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O (QUANTITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>128H50TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:56:30.092Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-128H50T5S</udiDi>
    <basicUdiDi>B-128H50T5S</basicUdiDi>
    <tradeName>Anti-Streptolysin O (ASO) Assay Kit (Latex-enhanced Immunoturbidimetric Method)</tradeName>
    <deviceName>Anti-Streptolysin O (ASO) Assay Kit (Latex-enhanced Immunoturbidimetric Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021104</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O (QUANTITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>128H50T</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:56:29.272Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-128H150TSCMU</udiDi>
    <basicUdiDi>B-128H150TSCMU</basicUdiDi>
    <tradeName>Anti-Streptolysin O (ASO) Assay Kit (Latex-enhanced Immunoturbidimetric Method)</tradeName>
    <deviceName>Anti-Streptolysin O (ASO) Assay Kit (Latex-enhanced Immunoturbidimetric Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021104</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O (QUANTITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>128H150TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:56:28.473Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-128H150THE</udiDi>
    <basicUdiDi>B-128H150THE</basicUdiDi>
    <tradeName>Anti-Streptolysin O (ASO) Assay Kit (Latex-enhanced Immunoturbidimetric Method)</tradeName>
    <deviceName>Anti-Streptolysin O (ASO) Assay Kit (Latex-enhanced Immunoturbidimetric Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021104</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O (QUANTITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>128H150T</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:56:27.694Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-11E7L</udiDi>
    <basicUdiDi>B-11E7L</basicUdiDi>
    <tradeName>D-11E7L</tradeName>
    <deviceName>Anti Streptolysin-O Test Kit (Latex Immunoturbidimetric Method)</deviceName>
    <manufacturerName>Shanghai Kehua Bio-engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026756</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021104</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O (QUANTITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:52:18.494Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699015281669</udiDi>
    <basicUdiDi>B-08699015281669</basicUdiDi>
    <tradeName>ASO TÜRBİDİMETRİK KİTİ</tradeName>
    <deviceName>ASO TURBIDIMETRIC REAGENT</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021104</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O (QUANTITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01R86-21</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:12:18.017Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683555622181</udiDi>
    <basicUdiDi>B-08683555622181</basicUdiDi>
    <tradeName>Anti-Streptolysin O [ASO] Kit</tradeName>
    <deviceName>Anti-Streptolysin O [ASO] Kit</deviceName>
    <manufacturerName>KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000040334</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021104</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O (QUANTITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B45033</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:52:36.124Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683555622174</udiDi>
    <basicUdiDi>B-08683555622174</basicUdiDi>
    <tradeName>Anti-Streptolysin O [ASO] Kit</tradeName>
    <deviceName>Anti-Streptolysin O [ASO] Kit</deviceName>
    <manufacturerName>KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000040334</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021104</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O (QUANTITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B45032</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:52:36.112Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683555622167</udiDi>
    <basicUdiDi>B-08683555622167</basicUdiDi>
    <tradeName>Anti-Streptolysin O [ASO] Kit</tradeName>
    <deviceName>Anti-Streptolysin O [ASO] Kit</deviceName>
    <manufacturerName>KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000040334</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021104</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O (QUANTITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B45031</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:52:36.068Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683555622150</udiDi>
    <basicUdiDi>B-08683555622150</basicUdiDi>
    <tradeName>Anti-Streptolysin O [ASO] Kit</tradeName>
    <deviceName>Anti-Streptolysin O [ASO] Kit</deviceName>
    <manufacturerName>KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000040334</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021104</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O (QUANTITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B45030</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:52:33.427Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683555619440</udiDi>
    <basicUdiDi>B-08683555619440</basicUdiDi>
    <tradeName>Anti-Streptolysin O [ASO] Kit</tradeName>
    <deviceName>Anti-Streptolysin O [ASO] Kit</deviceName>
    <manufacturerName>KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000040334</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021104</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O (QUANTITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B35032</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:51:47.742Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683555619426</udiDi>
    <basicUdiDi>B-08683555619426</basicUdiDi>
    <tradeName>Anti-Streptolysin O [ASO] Kit</tradeName>
    <deviceName>Anti-Streptolysin O [ASO] Kit</deviceName>
    <manufacturerName>KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000040334</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021104</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O (QUANTITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B35030-S</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:51:46.937Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683555619419</udiDi>
    <basicUdiDi>B-08683555619419</basicUdiDi>
    <tradeName>Anti-Streptolysin O [ASO]  Kit</tradeName>
    <deviceName>Anti-Streptolysin O [ASO]  Kit</deviceName>
    <manufacturerName>KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000040334</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021104</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O (QUANTITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B35030</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:51:46.135Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681812530743</udiDi>
    <basicUdiDi>B-08681812530743</basicUdiDi>
    <tradeName>ASO TÜRBİDİMETRİK KİTİ</tradeName>
    <deviceName>ASO TURBIDIMETRIC REAGENT</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021104</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O (QUANTITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08V3320</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T15:41:36.760Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681812530736</udiDi>
    <basicUdiDi>B-08681812530736</basicUdiDi>
    <tradeName>ASO TÜRBİDİMETRİK KİTİ</tradeName>
    <deviceName>ASO TURBIDIMETRIC REAGENT</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021104</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O (QUANTITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08V3325</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T15:41:35.995Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-084360386696697L3</udiDi>
    <basicUdiDi>B-084360386696697L3</basicUdiDi>
    <tradeName>ASO, R1 1 x 45 mL, R2 1 x 5 mL, CAL 1 x 1 mL</tradeName>
    <deviceName>ASO, R1 1 x 45 mL, R2 1 x 5 mL, CAL 1 x 1 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>W01021104</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O (QUANTITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0469</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:31:29.633Z</lastUpdated>
  </row>
</eudamedExport>