<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08809260471894</udiDi>
    <basicUdiDi>B-08809260471894</basicUdiDi>
    <tradeName>TRAUS Series</tradeName>
    <deviceName>TRAUS Series</deviceName>
    <manufacturerName>SAESHIN PRECISION CO.,LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000016345</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L1899</emdnCode>
    <emdnDescription>ELECTROSURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAB-R15</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:04:14.674Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809260471887</udiDi>
    <basicUdiDi>B-08809260471887</basicUdiDi>
    <tradeName>TRAUS Series</tradeName>
    <deviceName>TRAUS Series</deviceName>
    <manufacturerName>SAESHIN PRECISION CO.,LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000016345</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L1899</emdnCode>
    <emdnDescription>ELECTROSURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAB-R20</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:04:13.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809260471870</udiDi>
    <basicUdiDi>B-08809260471870</basicUdiDi>
    <tradeName>TRAUS Series</tradeName>
    <deviceName>TRAUS Series</deviceName>
    <manufacturerName>SAESHIN PRECISION CO.,LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000016345</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L1899</emdnCode>
    <emdnDescription>ELECTROSURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAB-R30</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:04:13.033Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809260471863</udiDi>
    <basicUdiDi>B-08809260471863</basicUdiDi>
    <tradeName>TRAUS Series</tradeName>
    <deviceName>TRAUS Series</deviceName>
    <manufacturerName>SAESHIN PRECISION CO.,LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000016345</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L1899</emdnCode>
    <emdnDescription>ELECTROSURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAB-S10</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:04:09.028Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809260471856</udiDi>
    <basicUdiDi>B-08809260471856</basicUdiDi>
    <tradeName>TRAUS Series</tradeName>
    <deviceName>TRAUS Series</deviceName>
    <manufacturerName>SAESHIN PRECISION CO.,LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000016345</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L1899</emdnCode>
    <emdnDescription>ELECTROSURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAB-S6</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:04:08.239Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809260471849</udiDi>
    <basicUdiDi>B-08809260471849</basicUdiDi>
    <tradeName>AIR MOTOR &amp; AIR HANDPIECE</tradeName>
    <deviceName>AIR MOTOR &amp; AIR HANDPIECE</deviceName>
    <manufacturerName>SAESHIN PRECISION CO.,LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000016345</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L1899</emdnCode>
    <emdnDescription>ELECTROSURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MRD22NN/ACL(B)-01C/AT-II/CAB20NDM4</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:04:07.435Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809260471832</udiDi>
    <basicUdiDi>B-08809260471832</basicUdiDi>
    <tradeName>AIR MOTOR &amp; AIR HANDPIECE &amp; COUPLING</tradeName>
    <deviceName>AIR MOTOR &amp; AIR HANDPIECE &amp; COUPLING</deviceName>
    <manufacturerName>SAESHIN PRECISION CO.,LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000016345</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L1899</emdnCode>
    <emdnDescription>ELECTROSURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAB10LK</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:04:06.623Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809260471818</udiDi>
    <basicUdiDi>B-08809260471818</basicUdiDi>
    <tradeName>AIR MOTOR &amp; AIR HANDPIECE &amp; COUPLING</tradeName>
    <deviceName>AIR MOTOR &amp; AIR HANDPIECE &amp; COUPLING</deviceName>
    <manufacturerName>SAESHIN PRECISION CO.,LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000016345</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L1899</emdnCode>
    <emdnDescription>ELECTROSURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAB10LN</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:04:02.618Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809260471801</udiDi>
    <basicUdiDi>B-08809260471801</basicUdiDi>
    <tradeName>AIR MOTOR &amp; AIR HANDPIECE &amp; COUPLING</tradeName>
    <deviceName>AIR MOTOR &amp; AIR HANDPIECE &amp; COUPLING</deviceName>
    <manufacturerName>SAESHIN PRECISION CO.,LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000016345</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L1899</emdnCode>
    <emdnDescription>ELECTROSURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ATN400</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:04:01.956Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809260471795</udiDi>
    <basicUdiDi>B-08809260471795</basicUdiDi>
    <tradeName>ACL Series</tradeName>
    <deviceName>ACL Series</deviceName>
    <manufacturerName>SAESHIN PRECISION CO.,LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000016345</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L1899</emdnCode>
    <emdnDescription>ELECTROSURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AT-I</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:04:01.036Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809260471733</udiDi>
    <basicUdiDi>B-08809260471733</basicUdiDi>
    <tradeName>ACL Series</tradeName>
    <deviceName>ACL Series</deviceName>
    <manufacturerName>SAESHIN PRECISION CO.,LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000016345</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L1899</emdnCode>
    <emdnDescription>ELECTROSURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACL(B)-65I</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:04:00.236Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809260471689</udiDi>
    <basicUdiDi>B-08809260471689</basicUdiDi>
    <tradeName>TRAUS SERIES</tradeName>
    <deviceName>TRAUS SERIES</deviceName>
    <manufacturerName>SAESHIN PRECISION CO.,LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000016345</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L1899</emdnCode>
    <emdnDescription>ELECTROSURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SIP20</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:03:56.221Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809260471672</udiDi>
    <basicUdiDi>B-08809260471672</basicUdiDi>
    <tradeName>ACL Series</tradeName>
    <deviceName>ACL Series</deviceName>
    <manufacturerName>SAESHIN PRECISION CO.,LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000016345</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L1899</emdnCode>
    <emdnDescription>ELECTROSURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>X-CUBE i</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:03:55.421Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809260471566</udiDi>
    <basicUdiDi>B-08809260471566</basicUdiDi>
    <tradeName>TRAUS SERIES</tradeName>
    <deviceName>TRAUS SERIES</deviceName>
    <manufacturerName>SAESHIN PRECISION CO.,LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000016345</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L1899</emdnCode>
    <emdnDescription>ELECTROSURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CRB46NN</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:03:54.620Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809260471559</udiDi>
    <basicUdiDi>B-08809260471559</basicUdiDi>
    <tradeName>TRAUS SERIES</tradeName>
    <deviceName>TRAUS SERIES</deviceName>
    <manufacturerName>SAESHIN PRECISION CO.,LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000016345</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L1899</emdnCode>
    <emdnDescription>ELECTROSURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CRB46LN</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:03:53.815Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809260471214</udiDi>
    <basicUdiDi>B-08809260471214</basicUdiDi>
    <tradeName>ACL Series</tradeName>
    <deviceName>ACL Series</deviceName>
    <manufacturerName>SAESHIN PRECISION CO.,LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000016345</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L1899</emdnCode>
    <emdnDescription>ELECTROSURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AT-II</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:03:49.807Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809260471207</udiDi>
    <basicUdiDi>B-08809260471207</basicUdiDi>
    <tradeName>ACL Series</tradeName>
    <deviceName>ACL Series</deviceName>
    <manufacturerName>SAESHIN PRECISION CO.,LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000016345</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L1899</emdnCode>
    <emdnDescription>ELECTROSURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACL(B)-03F</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:03:49.025Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809260471191</udiDi>
    <basicUdiDi>B-08809260471191</basicUdiDi>
    <tradeName>ACL Series</tradeName>
    <deviceName>ACL Series</deviceName>
    <manufacturerName>SAESHIN PRECISION CO.,LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000016345</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L1899</emdnCode>
    <emdnDescription>ELECTROSURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACL(B)-01C</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:03:48.228Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809260471054</udiDi>
    <basicUdiDi>B-08809260471054</basicUdiDi>
    <tradeName>ACL Series</tradeName>
    <deviceName>ACL Series</deviceName>
    <manufacturerName>SAESHIN PRECISION CO.,LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000016345</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L1899</emdnCode>
    <emdnDescription>ELECTROSURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>X-CUBE</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:03:47.417Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809260471023</udiDi>
    <basicUdiDi>B-08809260471023</basicUdiDi>
    <tradeName>ACL Series</tradeName>
    <deviceName>ACL Series</deviceName>
    <manufacturerName>SAESHIN PRECISION CO.,LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000016345</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L1899</emdnCode>
    <emdnDescription>ELECTROSURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>X-CUBE</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:03:43.415Z</lastUpdated>
  </row>
</eudamedExport>