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<eudamedExport entity="devices">
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    <udiDi>04260148896453</udiDi>
    <basicUdiDi>0426014889003-018XB</basicUdiDi>
    <tradeName>HPS™ 2.0</tradeName>
    <deviceName>HPS™ 2.0 Vice grip</deviceName>
    <manufacturerName>Paradigm Spine GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000011231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HAT90450</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:39:20.582Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260148896385</udiDi>
    <basicUdiDi>0426014889003-027XC</basicUdiDi>
    <tradeName>HPS™ 2.0</tradeName>
    <deviceName>HPS™ 2.0 Coupler template</deviceName>
    <manufacturerName>Paradigm Spine GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000011231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V030204</emdnCode>
    <emdnDescription>IMPLANT MEASUREMENT DEVICES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HAT90150</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:39:16.519Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260148896378</udiDi>
    <basicUdiDi>0426014889003-016X7</basicUdiDi>
    <tradeName>HPS™ 2.0</tradeName>
    <deviceName>HPS™2.0 MIS Rod inserter</deviceName>
    <manufacturerName>Paradigm Spine GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000011231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HAT90100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:39:15.806Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260148896439</udiDi>
    <basicUdiDi>0426014889003-004WY</basicUdiDi>
    <tradeName>HPS™ 2.0</tradeName>
    <deviceName>HPS™ Rod cutter</deviceName>
    <manufacturerName>Paradigm Spine GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000011231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HAT90300</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:39:14.120Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260148896408</udiDi>
    <basicUdiDi>0426014889003-003WW</basicUdiDi>
    <tradeName>HPS™ 2.0</tradeName>
    <deviceName>HPS™ Bending pliers</deviceName>
    <manufacturerName>Paradigm Spine GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000011231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HAT90200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:39:13.413Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260148896170</udiDi>
    <basicUdiDi>0426014889003-002WU</basicUdiDi>
    <tradeName>HPS™ 2.0</tradeName>
    <deviceName>HPS™ Cannulated 'T' Handle with Ratchet</deviceName>
    <manufacturerName>Paradigm Spine GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000011231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HAT40110</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:38:56.458Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260148895944</udiDi>
    <basicUdiDi>0426014889003-033X7</basicUdiDi>
    <tradeName>HPS™ 2.0</tradeName>
    <deviceName>HPS™ Torque wrench</deviceName>
    <manufacturerName>Paradigm Spine GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000011231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HAT00185</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:38:55.660Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260148894091</udiDi>
    <basicUdiDi>0426014889005-003XL</basicUdiDi>
    <tradeName>DCI™</tradeName>
    <deviceName>DCI™ insertion instrument</deviceName>
    <manufacturerName>Paradigm Spine GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000011231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CBT20110</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:38:54.862Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260148893490</udiDi>
    <basicUdiDi>0426014889004-037XS</basicUdiDi>
    <tradeName>DSS™</tradeName>
    <deviceName>DSS™ Coupler Length Adjuster</deviceName>
    <manufacturerName>Paradigm Spine GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000011231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V030204</emdnCode>
    <emdnDescription>IMPLANT MEASUREMENT DEVICES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DAT30301</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:38:54.054Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260148893377</udiDi>
    <basicUdiDi>0426014889004-010X6</basicUdiDi>
    <tradeName>DSS™</tradeName>
    <deviceName>DSS™ Pedicle Awl cannulated with k-wire</deviceName>
    <manufacturerName>Paradigm Spine GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000011231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DAT50265</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:38:50.059Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260148893018</udiDi>
    <basicUdiDi>0426014889004-003X9</basicUdiDi>
    <tradeName>DSS™</tradeName>
    <deviceName>DSS™ Ratchet</deviceName>
    <manufacturerName>Paradigm Spine GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000011231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DAT00165</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:38:49.345Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260148891601</udiDi>
    <basicUdiDi>0426014889004-001X5</basicUdiDi>
    <tradeName>DSS™</tradeName>
    <deviceName>DSS™ Sterilization tray</deviceName>
    <manufacturerName>Paradigm Spine GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000011231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S010399</emdnCode>
    <emdnDescription>MATERIALS FOR PACKAGING PACKS TO BE STERILIZED - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DAC00000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:38:47.655Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260148891090</udiDi>
    <basicUdiDi>0426014889004-002X7</basicUdiDi>
    <tradeName>DSS™</tradeName>
    <deviceName>DSS™ Cannulated 'T' Handle with ratchet</deviceName>
    <manufacturerName>Paradigm Spine GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000011231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DAT40120</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:38:46.863Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260148890284</udiDi>
    <basicUdiDi>0426014889018-043D</basicUdiDi>
    <tradeName>CoFix™</tradeName>
    <deviceName>coflex-F™ trial, 8mm</deviceName>
    <manufacturerName>Paradigm Spine GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000011231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RCT00010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:38:42.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260148890659</udiDi>
    <basicUdiDi>0426014889018-083M</basicUdiDi>
    <tradeName>DCI™</tradeName>
    <deviceName>DCI™ trial, 10x12x5</deviceName>
    <manufacturerName>Paradigm Spine GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000011231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CBT10126</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:38:42.918Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260148890147</udiDi>
    <basicUdiDi>0426014889001-006WE</basicUdiDi>
    <tradeName>coflex®</tradeName>
    <deviceName>coflex® Mallet</deviceName>
    <manufacturerName>Paradigm Spine GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000011231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0903</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY HAMMERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UAT20110</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:38:42.338Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260148890079</udiDi>
    <basicUdiDi>0426014889018-0137</basicUdiDi>
    <tradeName>coflex®</tradeName>
    <deviceName>coflex®™ Trial, 8mm</deviceName>
    <manufacturerName>Paradigm Spine GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000011231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UAT00010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:38:41.693Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260148896262</udiDi>
    <basicUdiDi>0426014889003-008X8</basicUdiDi>
    <tradeName>HPS™ 2.0</tradeName>
    <deviceName>HPS™ 2.0 Pedicle Ball tip probe, straight/curved</deviceName>
    <manufacturerName>Paradigm Spine GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000011231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HAT50500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:36:25.662Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260148896248</udiDi>
    <basicUdiDi>0426014889003-007X6</basicUdiDi>
    <tradeName>HPS™ 2.0</tradeName>
    <deviceName>HPS™ 2.0 Trocar awl</deviceName>
    <manufacturerName>Paradigm Spine GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000011231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HAT50250</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:36:24.850Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260148896231</udiDi>
    <basicUdiDi>0426014889003-006X4</basicUdiDi>
    <tradeName>HPS™ 2.0</tradeName>
    <deviceName>HPS™ Trocar</deviceName>
    <manufacturerName>Paradigm Spine GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000011231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HAT50100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:36:22.456Z</lastUpdated>
  </row>
</eudamedExport>