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<eudamedExport entity="devices">
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    <udiDi>06944270104201</udiDi>
    <basicUdiDi>69442701M111L7</basicUdiDi>
    <tradeName>06944270104201</tradeName>
    <deviceName>Autoclave Indicator Tape</deviceName>
    <manufacturerName>Jiangmen New Era External Use Drug Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000036495</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S9099</emdnCode>
    <emdnDescription>STERILISATION DEVICES (EXCLUDING CAT. D - Z) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>19mm*30m</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:04:57.556Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944270103884</udiDi>
    <basicUdiDi>69442701M131LD</basicUdiDi>
    <tradeName>06944270103884</tradeName>
    <deviceName>Autoclave Indicator Label</deviceName>
    <manufacturerName>Jiangmen New Era External Use Drug Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000036495</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S9099</emdnCode>
    <emdnDescription>STERILISATION DEVICES (EXCLUDING CAT. D - Z) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>单层铜版纸 30mm*50mm</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:04:56.353Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944270103877</udiDi>
    <basicUdiDi>69442701M131LD</basicUdiDi>
    <tradeName>06944270103877</tradeName>
    <deviceName>Autoclave Indicator Label</deviceName>
    <manufacturerName>Jiangmen New Era External Use Drug Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000036495</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S9099</emdnCode>
    <emdnDescription>STERILISATION DEVICES (EXCLUDING CAT. D - Z) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:04:50.346Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944270103860</udiDi>
    <basicUdiDi>69442701M131LD</basicUdiDi>
    <tradeName>06944270103860</tradeName>
    <deviceName>Autoclave Indicator Label</deviceName>
    <manufacturerName>Jiangmen New Era External Use Drug Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000036495</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S9099</emdnCode>
    <emdnDescription>STERILISATION DEVICES (EXCLUDING CAT. D - Z) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:04:49.364Z</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>
  <row>
    <udiDi>08809416740621</udiDi>
    <basicUdiDi>880941674C120DW</basicUdiDi>
    <tradeName>LOWTEM Crystal 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>LOWTEM Crystal 30</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:29:55.835Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809416740652</udiDi>
    <basicUdiDi>880941674C120DW</basicUdiDi>
    <tradeName>PLUSMA 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>PLUSMA 30</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:29:55.708Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809416740676</udiDi>
    <basicUdiDi>880941674C120DW</basicUdiDi>
    <tradeName>PLUSMA 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>PLUSMA 50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:29:55.674Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809416740799</udiDi>
    <basicUdiDi>880941674SA2L</basicUdiDi>
    <tradeName>SA-40</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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S900101</emdnCode>
    <emdnDescription>HYDROGEN PEROXIDE CARTRIDGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA-40</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:29:55.532Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809416740805</udiDi>
    <basicUdiDi>880941674SA2L</basicUdiDi>
    <tradeName>SA-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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S900101</emdnCode>
    <emdnDescription>HYDROGEN PEROXIDE CARTRIDGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA-50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:29:55.511Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809416740812</udiDi>
    <basicUdiDi>880941674SA2L</basicUdiDi>
    <tradeName>SA-100</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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S900101</emdnCode>
    <emdnDescription>HYDROGEN PEROXIDE CARTRIDGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA-100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:29:55.490Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809416740829</udiDi>
    <basicUdiDi>880941674SA2L</basicUdiDi>
    <tradeName>SA-120</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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S900101</emdnCode>
    <emdnDescription>HYDROGEN PEROXIDE CARTRIDGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA-120</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:29:55.464Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809416740836</udiDi>
    <basicUdiDi>880941674SA2L</basicUdiDi>
    <tradeName>SA-150</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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S900101</emdnCode>
    <emdnDescription>HYDROGEN PEROXIDE CARTRIDGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA-150</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:29:55.441Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809416740843</udiDi>
    <basicUdiDi>880941674C120DW</basicUdiDi>
    <tradeName>LOWTEM Smart 10</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>LOWTEM Smart 10</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:29:55.421Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809416740867</udiDi>
    <basicUdiDi>880941674SA2L</basicUdiDi>
    <tradeName>SA-10</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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S900101</emdnCode>
    <emdnDescription>HYDROGEN PEROXIDE CARTRIDGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA-10</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:29:46.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978194940287</udiDi>
    <basicUdiDi>697819494SCIS01Z3</basicUdiDi>
    <tradeName>06978194940287</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tianjin Li Feng Industry and Trade Development Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045898</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S9099</emdnCode>
    <emdnDescription>STERILISATION DEVICES (EXCLUDING CAT. D - Z) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Type 4  20mm*140mm</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:48:11.473Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809293789409</udiDi>
    <basicUdiDi>880929378934P4</basicUdiDi>
    <tradeName>08809293789409</tradeName>
    <deviceName></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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S900101</emdnCode>
    <emdnDescription>HYDROGEN PEROXIDE CARTRIDGES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>REMO-005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T06:53:40.983Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809293789454</udiDi>
    <basicUdiDi>880929378017MP</basicUdiDi>
    <tradeName>08809293789454</tradeName>
    <deviceName></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>FPG-1300U</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T06:53:40.908Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974409690213</udiDi>
    <basicUdiDi>697440969BDTESTSM</basicUdiDi>
    <tradeName>06974409690213</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEDIWISH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000008849</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S9099</emdnCode>
    <emdnDescription>STERILISATION DEVICES (EXCLUDING CAT. D - Z) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BD4090</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T04:14:02.630Z</lastUpdated>
  </row>
</eudamedExport>