<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>07610733800285</udiDi>
    <basicUdiDi>7610733MD61029AT</basicUdiDi>
    <tradeName>OPERACE</tradeName>
    <deviceName>Extraction Reamers</deviceName>
    <manufacturerName>PB Swiss Tools AG</manufacturerName>
    <manufacturerSrn>CH-MF-000040741</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P091399</emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80028</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:36:38.907Z</lastUpdated>
  </row>
  <row>
    <udiDi>05420060345227</udiDi>
    <basicUdiDi>54200603B0086TQ</basicUdiDi>
    <tradeName>Materialise Titanium 3D Printed Guides</tradeName>
    <deviceName>Materialise Titanium 3D Printed Guides</deviceName>
    <manufacturerName>Materialise NV</manufacturerName>
    <manufacturerSrn>BE-MF-000000034</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P091399</emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMFsTi051D</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:26:29.024Z</lastUpdated>
  </row>
  <row>
    <udiDi>05420060344923</udiDi>
    <basicUdiDi>54200603B0053T9</basicUdiDi>
    <tradeName>Materialise Titanium 3D Printed Guides</tradeName>
    <deviceName>Materialise Titanium 3D Printed Guides</deviceName>
    <manufacturerName>Materialise NV</manufacturerName>
    <manufacturerSrn>BE-MF-000000034</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P091399</emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMF.Ti060D</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:26:28.882Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973877667031</udiDi>
    <basicUdiDi>B-06973877667031</basicUdiDi>
    <tradeName>PragmaTool</tradeName>
    <deviceName>Drills</deviceName>
    <manufacturerName>Hangzhou Rejoin Mastin Medical Device Co.，Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006572</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P091303</emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT DRILL BITS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RJ8112037</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:12:36.388Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973877667024</udiDi>
    <basicUdiDi>B-06973877667024</basicUdiDi>
    <tradeName>PragmaTool</tradeName>
    <deviceName>Drills</deviceName>
    <manufacturerName>Hangzhou Rejoin Mastin Medical Device Co.，Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006572</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P091303</emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT DRILL BITS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RJ8112035</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:12:34.000Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973877666942</udiDi>
    <basicUdiDi>B-06973877666942</basicUdiDi>
    <tradeName>PragmaTool</tradeName>
    <deviceName>Drills</deviceName>
    <manufacturerName>Hangzhou Rejoin Mastin Medical Device Co.，Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006572</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P091303</emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT DRILL BITS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RJ8112001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:12:32.408Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973877666959</udiDi>
    <basicUdiDi>B-06973877666959</basicUdiDi>
    <tradeName>PragmaTool</tradeName>
    <deviceName>Drills</deviceName>
    <manufacturerName>Hangzhou Rejoin Mastin Medical Device Co.，Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006572</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P091303</emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT DRILL BITS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RJ8112002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:12:31.589Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973877664788</udiDi>
    <basicUdiDi>B-06973877664788</basicUdiDi>
    <tradeName>06973877664788</tradeName>
    <deviceName>Drills</deviceName>
    <manufacturerName>Hangzhou Rejoin Mastin Medical Device Co.，Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006572</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P091303</emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT DRILL BITS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RJ8112161</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:12:30.003Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973877666911</udiDi>
    <basicUdiDi>B-06973877666911</basicUdiDi>
    <tradeName>06973877666911</tradeName>
    <deviceName>Drills</deviceName>
    <manufacturerName>Hangzhou Rejoin Mastin Medical Device Co.，Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006572</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P091303</emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT DRILL BITS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RJ8112069</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:12:27.701Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973877664771</udiDi>
    <basicUdiDi>B-06973877664771</basicUdiDi>
    <tradeName>06973877664771</tradeName>
    <deviceName>Drills</deviceName>
    <manufacturerName>Hangzhou Rejoin Mastin Medical Device Co.，Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006572</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P091303</emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT DRILL BITS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RJ8112159</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:12:13.921Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973877664016</udiDi>
    <basicUdiDi>B-06973877664016</basicUdiDi>
    <tradeName>PragmaTool</tradeName>
    <deviceName>Drills</deviceName>
    <manufacturerName>Hangzhou Rejoin Mastin Medical Device Co.，Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006572</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P091303</emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT DRILL BITS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RJ8112034</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:12:11.522Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973877664009</udiDi>
    <basicUdiDi>B-06973877664009</basicUdiDi>
    <tradeName>PragmaTool</tradeName>
    <deviceName>Drills</deviceName>
    <manufacturerName>Hangzhou Rejoin Mastin Medical Device Co.，Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006572</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P091303</emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT DRILL BITS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RJ8112033</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:12:10.407Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973877663996</udiDi>
    <basicUdiDi>B-06973877663996</basicUdiDi>
    <tradeName>PragmaTool</tradeName>
    <deviceName>Drills</deviceName>
    <manufacturerName>Hangzhou Rejoin Mastin Medical Device Co.，Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006572</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P091303</emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT DRILL BITS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RJ8112032</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:12:09.118Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973877663989</udiDi>
    <basicUdiDi>B-06973877663989</basicUdiDi>
    <tradeName>PragmaTool</tradeName>
    <deviceName>Drills</deviceName>
    <manufacturerName>Hangzhou Rejoin Mastin Medical Device Co.，Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006572</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P091303</emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT DRILL BITS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RJ8112030</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:12:07.505Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973877663972</udiDi>
    <basicUdiDi>B-06973877663972</basicUdiDi>
    <tradeName>PragmaTool</tradeName>
    <deviceName>Drills</deviceName>
    <manufacturerName>Hangzhou Rejoin Mastin Medical Device Co.，Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006572</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P091303</emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT DRILL BITS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RJ8112029</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:12:05.109Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973877663538</udiDi>
    <basicUdiDi>B-06973877663538</basicUdiDi>
    <tradeName>PragmaTool</tradeName>
    <deviceName>Drills</deviceName>
    <manufacturerName>Hangzhou Rejoin Mastin Medical Device Co.，Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006572</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P091303</emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT DRILL BITS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RJ8112031</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:12:03.528Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941832533844</udiDi>
    <basicUdiDi>B-06941832533844</basicUdiDi>
    <tradeName>06941832533844</tradeName>
    <deviceName>Drills</deviceName>
    <manufacturerName>Hangzhou Rejoin Mastin Medical Device Co.，Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006572</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P091303</emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT DRILL BITS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RJ8112053</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:45:36.245Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941832533493</udiDi>
    <basicUdiDi>B-06941832533493</basicUdiDi>
    <tradeName>06941832533493</tradeName>
    <deviceName>Drills</deviceName>
    <manufacturerName>Hangzhou Rejoin Mastin Medical Device Co.，Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006572</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P091303</emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT DRILL BITS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RJ8112150</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:45:35.435Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941832533486</udiDi>
    <basicUdiDi>B-06941832533486</basicUdiDi>
    <tradeName>06941832533486</tradeName>
    <deviceName>Drills</deviceName>
    <manufacturerName>Hangzhou Rejoin Mastin Medical Device Co.，Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006572</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P091303</emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT DRILL BITS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RJ8112115</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:45:30.659Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941832533479</udiDi>
    <basicUdiDi>B-06941832533479</basicUdiDi>
    <tradeName>06941832533479</tradeName>
    <deviceName>Drills</deviceName>
    <manufacturerName>Hangzhou Rejoin Mastin Medical Device Co.，Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006572</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P091303</emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT DRILL BITS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RJ8112114</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:45:14.562Z</lastUpdated>
  </row>
</eudamedExport>