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<eudamedExport entity="devices">
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    <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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PLUSMA 50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:29:55.674Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809416740782</udiDi>
    <basicUdiDi>880941674SA2L</basicUdiDi>
    <tradeName>SA-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 IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA-30</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:29:55.552Z</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA-10</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:29:46.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023700015</udiDi>
    <basicUdiDi>B-08800023700015</basicUdiDi>
    <tradeName>ANGUIS Guidewire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SUNGJIN-HITECH CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000036002</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GW-A35260</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T10:31:42.605Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023700022</udiDi>
    <basicUdiDi>B-08800023700022</basicUdiDi>
    <tradeName>ANGUIS Guidewire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SUNGJIN-HITECH CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000036002</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GW-15J35110</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T10:31:42.593Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023700039</udiDi>
    <basicUdiDi>B-08800023700039</basicUdiDi>
    <tradeName>ANGUIS Guidewire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SUNGJIN-HITECH CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000036002</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GW-15J35150</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T10:31:42.584Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023700046</udiDi>
    <basicUdiDi>B-08800023700046</basicUdiDi>
    <tradeName>ANGUIS Guidewire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SUNGJIN-HITECH CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000036002</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GW-A35110</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T10:31:42.575Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023700053</udiDi>
    <basicUdiDi>B-08800023700053</basicUdiDi>
    <tradeName>ANGUIS Guidewire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SUNGJIN-HITECH CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000036002</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GW-A35150</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T10:31:42.562Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023700060</udiDi>
    <basicUdiDi>B-08800023700060</basicUdiDi>
    <tradeName>ANGUIS Guidewire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SUNGJIN-HITECH CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000036002</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GW-A35180</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T10:31:42.537Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023700077</udiDi>
    <basicUdiDi>B-08800023700077</basicUdiDi>
    <tradeName>ANGUIS Guidewire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SUNGJIN-HITECH CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000036002</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GW-15J35180</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T10:31:42.528Z</lastUpdated>
  </row>
</eudamedExport>