<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08800045302938</udiDi>
    <basicUdiDi>88000453BEOTI001KA</basicUdiDi>
    <tradeName>Driver Shaft</tradeName>
    <deviceName>Orthopaedic Instrument</deviceName>
    <manufacturerName>ORTHOTECH Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000048890</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP20-29</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:24:40.359Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800045302952</udiDi>
    <basicUdiDi>88000453BEOTI001KA</basicUdiDi>
    <tradeName>Guide</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ORTHOTECH Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000048890</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP20-15</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T10:01:08.943Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800045302969</udiDi>
    <basicUdiDi>88000453BEOTI001KA</basicUdiDi>
    <tradeName>Handle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ORTHOTECH Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000048890</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP20-10</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T10:01:08.928Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800045302976</udiDi>
    <basicUdiDi>88000453BEOTI001KA</basicUdiDi>
    <tradeName>Bender</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ORTHOTECH Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000048890</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP20-26</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T10:01:08.910Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800045302983</udiDi>
    <basicUdiDi>88000453BEOTI001KA</basicUdiDi>
    <tradeName>Bender</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ORTHOTECH Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000048890</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP20-27</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T10:01:08.895Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800045303003</udiDi>
    <basicUdiDi>88000453BEOTI001KA</basicUdiDi>
    <tradeName>Driver</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ORTHOTECH Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000048890</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP20-16</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T10:01:08.883Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800045303034</udiDi>
    <basicUdiDi>88000453BEOTI001KA</basicUdiDi>
    <tradeName>Guide</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ORTHOTECH Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000048890</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP20-11</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T10:01:08.871Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800045303041</udiDi>
    <basicUdiDi>88000453BEOTI001KA</basicUdiDi>
    <tradeName>Guide</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ORTHOTECH Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000048890</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP20-13</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T10:01:08.854Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800045303058</udiDi>
    <basicUdiDi>88000453BEOTI001KA</basicUdiDi>
    <tradeName>Guide</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ORTHOTECH Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000048890</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP20-14</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T10:01:08.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800045323391</udiDi>
    <basicUdiDi>88000453BEOTI001KA</basicUdiDi>
    <tradeName>Guide</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ORTHOTECH Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000048890</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C0001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T10:01:08.818Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800045323407</udiDi>
    <basicUdiDi>88000453BEOTI001KA</basicUdiDi>
    <tradeName>Guide Pin</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ORTHOTECH Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000048890</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C0002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T10:01:08.806Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800045323414</udiDi>
    <basicUdiDi>88000453BEOTI001KA</basicUdiDi>
    <tradeName>Driver Shaft</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ORTHOTECH Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000048890</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C0004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T10:01:08.796Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800045323445</udiDi>
    <basicUdiDi>88000453BEOTI001KA</basicUdiDi>
    <tradeName>Guide</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ORTHOTECH Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000048890</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C0011</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T10:01:08.787Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800045323452</udiDi>
    <basicUdiDi>88000453BEOTI001KA</basicUdiDi>
    <tradeName>Guide Pin</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ORTHOTECH Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000048890</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C0012</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T10:01:08.779Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800045323469</udiDi>
    <basicUdiDi>88000453BEOTI001KA</basicUdiDi>
    <tradeName>Driver Shaft</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ORTHOTECH Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000048890</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C0014</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T10:01:08.765Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800045323490</udiDi>
    <basicUdiDi>88000453BEOTI001KA</basicUdiDi>
    <tradeName>Guide</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ORTHOTECH Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000048890</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C0021</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T10:01:08.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800045323506</udiDi>
    <basicUdiDi>88000453BEOTI001KA</basicUdiDi>
    <tradeName>Guide Pin</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ORTHOTECH Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000048890</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C0022</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T10:01:08.734Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800045323513</udiDi>
    <basicUdiDi>88000453BEOTI001KA</basicUdiDi>
    <tradeName>Driver Shaft</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ORTHOTECH Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000048890</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C0024</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T10:01:08.721Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800045323544</udiDi>
    <basicUdiDi>88000453BEOTI001KA</basicUdiDi>
    <tradeName>Gauge</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ORTHOTECH Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000048890</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C0042</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T10:01:08.708Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800045323551</udiDi>
    <basicUdiDi>88000453BEOTI001KA</basicUdiDi>
    <tradeName>Gauge</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ORTHOTECH Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000048890</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C0043</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T10:01:08.697Z</lastUpdated>
  </row>
</eudamedExport>