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<eudamedExport entity="devices">
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    <udiDi>10705037067244</udiDi>
    <basicUdiDi>0705037A010000000000001H8</basicUdiDi>
    <tradeName>STERRAD™ SEALSURE™ Chemical Indicator Tape</tradeName>
    <deviceName>STERRAD™ SEALSURE™ Chemical Indicator Tape</deviceName>
    <manufacturerName>Advanced Sterilization Products, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008427</manufacturerSrn>
    <authorisedRepresentativeName>ASP, The Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002057</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S900199</emdnCode>
    <emdnDescription>DEVICES FOR GAS PLASMA STERILISATION (EXCLUDING CAT. D - Z) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14202NL</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-30T16:52:58.819Z</lastUpdated>
  </row>
  <row>
    <udiDi>10705037016198</udiDi>
    <basicUdiDi>0705037A020000000000002JM</basicUdiDi>
    <tradeName>STERRAD™ Chemical Indicator Strip</tradeName>
    <deviceName>STERRAD™ Chemical Indicator Strip</deviceName>
    <manufacturerName>Advanced Sterilization Products, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008427</manufacturerSrn>
    <authorisedRepresentativeName>ASP, The Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002057</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S900199</emdnCode>
    <emdnDescription>DEVICES FOR GAS PLASMA STERILISATION (EXCLUDING CAT. D - Z) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14100</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-30T16:52:45.896Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800066500283</udiDi>
    <basicUdiDi>B-08800066500283</basicUdiDi>
    <tradeName>08800066500283</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Plasmapp Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000012193</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>S900199</emdnCode>
    <emdnDescription>DEVICES FOR GAS PLASMA STERILISATION (EXCLUDING CAT. D - Z) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STERLINK</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:12:57.728Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809416740478</udiDi>
    <basicUdiDi>880941674C120DW</basicUdiDi>
    <tradeName>LOWTEM Crystal 50</tradeName>
    <deviceName>Low temperature hydrogen peroxide sterilizers for invasive and non invasive medical device</deviceName>
    <manufacturerName>LowTem Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000016177</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S900199</emdnCode>
    <emdnDescription>DEVICES FOR GAS PLASMA STERILISATION (EXCLUDING CAT. D - Z) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LOWTEM Crystal 50</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:57:06.863Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809293789423</udiDi>
    <basicUdiDi>880929378942P3</basicUdiDi>
    <tradeName>08809293789423</tradeName>
    <deviceName>Low Temperature Hydrogen Peroxide Sterilizer</deviceName>
    <manufacturerName>RENOSEM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000023080</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S900199</emdnCode>
    <emdnDescription>DEVICES FOR GAS PLASMA STERILISATION (EXCLUDING CAT. D - Z) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>REOM-011</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:54:30.216Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809293788938</udiDi>
    <basicUdiDi>880929378893PF</basicUdiDi>
    <tradeName>08809293788938</tradeName>
    <deviceName>Low Temperature Hydrogen Peroxide Sterilizer</deviceName>
    <manufacturerName>RENOSEM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000023080</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S900199</emdnCode>
    <emdnDescription>DEVICES FOR GAS PLASMA STERILISATION (EXCLUDING CAT. D - Z) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>REOM-010</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:50:33.233Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809293788884</udiDi>
    <basicUdiDi>880929378888PN</basicUdiDi>
    <tradeName>08809293788884</tradeName>
    <deviceName>Low Temperature Hydrogen Peroxide Sterilizer</deviceName>
    <manufacturerName>RENOSEM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000023080</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S900199</emdnCode>
    <emdnDescription>DEVICES FOR GAS PLASMA STERILISATION (EXCLUDING CAT. D - Z) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>REOM-008</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:50:30.847Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809293788877</udiDi>
    <basicUdiDi>880929378887PL</basicUdiDi>
    <tradeName>08809293788877</tradeName>
    <deviceName>Low Temperature Hydrogen Peroxide Sterilizer</deviceName>
    <manufacturerName>RENOSEM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000023080</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S900199</emdnCode>
    <emdnDescription>DEVICES FOR GAS PLASMA STERILISATION (EXCLUDING CAT. D - Z) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>REOM-006</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:50:29.207Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809293780178</udiDi>
    <basicUdiDi>880929378017MP</basicUdiDi>
    <tradeName>08809293780178</tradeName>
    <deviceName>Low Temperature Hydrogen Peroxide Sterilizer</deviceName>
    <manufacturerName>RENOSEM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000023080</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S900199</emdnCode>
    <emdnDescription>DEVICES FOR GAS PLASMA STERILISATION (EXCLUDING CAT. D - Z) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>REOM-004</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:50:28.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809293780024</udiDi>
    <basicUdiDi>880929378002MA</basicUdiDi>
    <tradeName>08809293780024</tradeName>
    <deviceName>Low Temperature Hydrogen Peroxide Sterilizer</deviceName>
    <manufacturerName>RENOSEM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000023080</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S900199</emdnCode>
    <emdnDescription>DEVICES FOR GAS PLASMA STERILISATION (EXCLUDING CAT. D - Z) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RENO-D50</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:50:26.803Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809293780017</udiDi>
    <basicUdiDi>880929378001M8</basicUdiDi>
    <tradeName>08809293780017</tradeName>
    <deviceName>Low Temperature Hydrogen Peroxide Sterilizer</deviceName>
    <manufacturerName>RENOSEM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000023080</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S900199</emdnCode>
    <emdnDescription>DEVICES FOR GAS PLASMA STERILISATION (EXCLUDING CAT. D - Z) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>REOM-002</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:50:24.398Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800066500276</udiDi>
    <basicUdiDi>88000665PLASTPEU8Y</basicUdiDi>
    <tradeName>08800066500276</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Plasmapp Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000012193</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S900199</emdnCode>
    <emdnDescription>DEVICES FOR GAS PLASMA STERILISATION (EXCLUDING CAT. D - Z) - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>STERLINK</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:27:19.031Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681020039618</udiDi>
    <basicUdiDi>8681020039SMPL7G</basicUdiDi>
    <tradeName>Low Temperature Sterilizer</tradeName>
    <deviceName>Low Temperature Sterilizer</deviceName>
    <manufacturerName>STERİLMED MEDİCAL ELEKTRİK ELEKTRONİK OTOMASYON İNŞAAT GIDA SANAYİ VE DIŞ TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000018720</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S900199</emdnCode>
    <emdnDescription>DEVICES FOR GAS PLASMA STERILISATION (EXCLUDING CAT. D - Z) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PL0108S1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:23:20.905Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973970180000</udiDi>
    <basicUdiDi>697397018000MN</basicUdiDi>
    <tradeName>Plasma Sterilizer</tradeName>
    <deviceName>Plasma Sterilizer</deviceName>
    <manufacturerName>Laoken Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000036797</manufacturerSrn>
    <authorisedRepresentativeName>Share info GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005132</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S900199</emdnCode>
    <emdnDescription>DEVICES FOR GAS PLASMA STERILISATION (EXCLUDING CAT. D - Z) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LK/MJG-50</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:18:11.769Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770026153000</udiDi>
    <basicUdiDi>37700261534151536K</basicUdiDi>
    <tradeName>Aqsaniit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aurora</manufacturerName>
    <manufacturerSrn>FR-MF-000024055</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>S900199</emdnCode>
    <emdnDescription>DEVICES FOR GAS PLASMA STERILISATION (EXCLUDING CAT. D - Z) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AQS</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:07:42.401Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973970180017</udiDi>
    <basicUdiDi>697397018000MN</basicUdiDi>
    <tradeName>Plasma Sterilizer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Laoken Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000036797</manufacturerSrn>
    <authorisedRepresentativeName>Share info GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005132</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S900199</emdnCode>
    <emdnDescription>DEVICES FOR GAS PLASMA STERILISATION (EXCLUDING CAT. D - Z) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LK/MJG-100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:53:32.818Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973970180024</udiDi>
    <basicUdiDi>697397018000MN</basicUdiDi>
    <tradeName>Plasma Sterilizer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Laoken Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000036797</manufacturerSrn>
    <authorisedRepresentativeName>Share info GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005132</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S900199</emdnCode>
    <emdnDescription>DEVICES FOR GAS PLASMA STERILISATION (EXCLUDING CAT. D - Z) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K/MJG-150</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:53:23.357Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973970180031</udiDi>
    <basicUdiDi>697397018000MN</basicUdiDi>
    <tradeName>Plasma Sterilizer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Laoken Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000036797</manufacturerSrn>
    <authorisedRepresentativeName>Share info GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005132</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S900199</emdnCode>
    <emdnDescription>DEVICES FOR GAS PLASMA STERILISATION (EXCLUDING CAT. D - Z) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LK/MJG-150D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:53:23.201Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809416740560</udiDi>
    <basicUdiDi>880941674C120DW</basicUdiDi>
    <tradeName>PROHS 50</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LowTem Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000016177</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S900199</emdnCode>
    <emdnDescription>DEVICES FOR GAS PLASMA STERILISATION (EXCLUDING CAT. D - Z) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PROHS 50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:29:56.013Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809416740584</udiDi>
    <basicUdiDi>880941674C120DW</basicUdiDi>
    <tradeName>PROHS 30</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LowTem Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000016177</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S900199</emdnCode>
    <emdnDescription>DEVICES FOR GAS PLASMA STERILISATION (EXCLUDING CAT. D - Z) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PROHS 30</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:29:55.990Z</lastUpdated>
  </row>
</eudamedExport>