<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08800061323078</udiDi>
    <basicUdiDi>B-08800061323078</basicUdiDi>
    <tradeName>AccelFix Spinal Fixation System (Sterile)</tradeName>
    <deviceName>AccelFix Spinal Fixation System (Sterile)</deviceName>
    <manufacturerName>L&amp;K Biomed</manufacturerName>
    <manufacturerSrn>KR-MF-000033200</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09070302</emdnCode>
    <emdnDescription>THORACOLUMBOSACRAL FIXATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8101-75125S</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-04T08:45:23.815Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800061323061</udiDi>
    <basicUdiDi>B-08800061323061</basicUdiDi>
    <tradeName>AccelFix Spinal Fixation System (Sterile)</tradeName>
    <deviceName>AccelFix Spinal Fixation System (Sterile)</deviceName>
    <manufacturerName>L&amp;K Biomed</manufacturerName>
    <manufacturerSrn>KR-MF-000033200</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09070302</emdnCode>
    <emdnDescription>THORACOLUMBOSACRAL FIXATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8101-75120S</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-04T08:45:23.021Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800061323030</udiDi>
    <basicUdiDi>B-08800061323030</basicUdiDi>
    <tradeName>AccelFix Spinal Fixation System (Sterile)</tradeName>
    <deviceName>AccelFix Spinal Fixation System (Sterile)</deviceName>
    <manufacturerName>L&amp;K Biomed</manufacturerName>
    <manufacturerSrn>KR-MF-000033200</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09070302</emdnCode>
    <emdnDescription>THORACOLUMBOSACRAL FIXATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8101-75105S</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-04T08:45:19.015Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800061323023</udiDi>
    <basicUdiDi>B-08800061323023</basicUdiDi>
    <tradeName>AccelFix Spinal Fixation System (Sterile)</tradeName>
    <deviceName>AccelFix Spinal Fixation System (Sterile)</deviceName>
    <manufacturerName>L&amp;K Biomed</manufacturerName>
    <manufacturerSrn>KR-MF-000033200</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09070302</emdnCode>
    <emdnDescription>THORACOLUMBOSACRAL FIXATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8101-75100S</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-04T08:45:18.229Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800061323054</udiDi>
    <basicUdiDi>B-08800061323054</basicUdiDi>
    <tradeName>AccelFix Spinal Fixation System (Sterile)</tradeName>
    <deviceName>AccelFix Spinal Fixation System (Sterile)</deviceName>
    <manufacturerName>L&amp;K Biomed</manufacturerName>
    <manufacturerSrn>KR-MF-000033200</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09070302</emdnCode>
    <emdnDescription>THORACOLUMBOSACRAL FIXATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8101-75115S</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-04T08:45:17.416Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800061323047</udiDi>
    <basicUdiDi>B-08800061323047</basicUdiDi>
    <tradeName>AccelFix Spinal Fixation System (Sterile)</tradeName>
    <deviceName>AccelFix Spinal Fixation System (Sterile)</deviceName>
    <manufacturerName>L&amp;K Biomed</manufacturerName>
    <manufacturerSrn>KR-MF-000033200</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09070302</emdnCode>
    <emdnDescription>THORACOLUMBOSACRAL FIXATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8101-75110S</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-04T08:45:16.720Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800061323016</udiDi>
    <basicUdiDi>B-08800061323016</basicUdiDi>
    <tradeName>AccelFix Spinal Fixation System (Sterile)</tradeName>
    <deviceName>AccelFix Spinal Fixation System (Sterile)</deviceName>
    <manufacturerName>L&amp;K Biomed</manufacturerName>
    <manufacturerSrn>KR-MF-000033200</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09070302</emdnCode>
    <emdnDescription>THORACOLUMBOSACRAL FIXATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8101-7595S</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-04T08:44:59.760Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800061323009</udiDi>
    <basicUdiDi>B-08800061323009</basicUdiDi>
    <tradeName>AccelFix Spinal Fixation System (Sterile)</tradeName>
    <deviceName>AccelFix Spinal Fixation System (Sterile)</deviceName>
    <manufacturerName>L&amp;K Biomed</manufacturerName>
    <manufacturerSrn>KR-MF-000033200</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09070302</emdnCode>
    <emdnDescription>THORACOLUMBOSACRAL FIXATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8101-7590S</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-04T08:44:58.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800061322996</udiDi>
    <basicUdiDi>B-08800061322996</basicUdiDi>
    <tradeName>AccelFix Spinal Fixation System (Sterile)</tradeName>
    <deviceName>AccelFix Spinal Fixation System (Sterile)</deviceName>
    <manufacturerName>L&amp;K Biomed</manufacturerName>
    <manufacturerSrn>KR-MF-000033200</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09070302</emdnCode>
    <emdnDescription>THORACOLUMBOSACRAL FIXATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8101-7585S</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-04T08:44:58.343Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800061322989</udiDi>
    <basicUdiDi>B-08800061322989</basicUdiDi>
    <tradeName>AccelFix Spinal Fixation System (Sterile)</tradeName>
    <deviceName>AccelFix Spinal Fixation System (Sterile)</deviceName>
    <manufacturerName>L&amp;K Biomed</manufacturerName>
    <manufacturerSrn>KR-MF-000033200</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09070302</emdnCode>
    <emdnDescription>THORACOLUMBOSACRAL FIXATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8101-7580S</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-04T08:44:57.343Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800061322972</udiDi>
    <basicUdiDi>B-08800061322972</basicUdiDi>
    <tradeName>AccelFix Spinal Fixation System (Sterile)</tradeName>
    <deviceName>AccelFix Spinal Fixation System (Sterile)</deviceName>
    <manufacturerName>L&amp;K Biomed</manufacturerName>
    <manufacturerSrn>KR-MF-000033200</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09070302</emdnCode>
    <emdnDescription>THORACOLUMBOSACRAL FIXATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8101-7575S</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-04T08:44:53.519Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800061322965</udiDi>
    <basicUdiDi>B-08800061322965</basicUdiDi>
    <tradeName>AccelFix Spinal Fixation System (Sterile)</tradeName>
    <deviceName>AccelFix Spinal Fixation System (Sterile)</deviceName>
    <manufacturerName>L&amp;K Biomed</manufacturerName>
    <manufacturerSrn>KR-MF-000033200</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09070302</emdnCode>
    <emdnDescription>THORACOLUMBOSACRAL FIXATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8101-7570S</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-04T08:44:52.540Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800061322958</udiDi>
    <basicUdiDi>B-08800061322958</basicUdiDi>
    <tradeName>AccelFix Spinal Fixation System (Sterile)</tradeName>
    <deviceName>AccelFix Spinal Fixation System (Sterile)</deviceName>
    <manufacturerName>L&amp;K Biomed</manufacturerName>
    <manufacturerSrn>KR-MF-000033200</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09070302</emdnCode>
    <emdnDescription>THORACOLUMBOSACRAL FIXATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8101-7565S</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-04T08:44:52.033Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800061322941</udiDi>
    <basicUdiDi>B-08800061322941</basicUdiDi>
    <tradeName>AccelFix Spinal Fixation System (Sterile)</tradeName>
    <deviceName>AccelFix Spinal Fixation System (Sterile)</deviceName>
    <manufacturerName>L&amp;K Biomed</manufacturerName>
    <manufacturerSrn>KR-MF-000033200</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09070302</emdnCode>
    <emdnDescription>THORACOLUMBOSACRAL FIXATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8101-7560S</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-04T08:44:51.176Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800061322934</udiDi>
    <basicUdiDi>B-08800061322934</basicUdiDi>
    <tradeName>AccelFix Spinal Fixation System (Sterile)</tradeName>
    <deviceName>AccelFix Spinal Fixation System (Sterile)</deviceName>
    <manufacturerName>L&amp;K Biomed</manufacturerName>
    <manufacturerSrn>KR-MF-000033200</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09070302</emdnCode>
    <emdnDescription>THORACOLUMBOSACRAL FIXATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8101-7555S</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-04T08:44:46.929Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800061322927</udiDi>
    <basicUdiDi>B-08800061322927</basicUdiDi>
    <tradeName>AccelFix Spinal Fixation System (Sterile)</tradeName>
    <deviceName>AccelFix Spinal Fixation System (Sterile)</deviceName>
    <manufacturerName>L&amp;K Biomed</manufacturerName>
    <manufacturerSrn>KR-MF-000033200</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09070302</emdnCode>
    <emdnDescription>THORACOLUMBOSACRAL FIXATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8101-7550S</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-04T08:44:46.133Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376509138</udiDi>
    <basicUdiDi>B-08682376509138</basicUdiDi>
    <tradeName>4U</tradeName>
    <deviceName>4U SPINAL PEDICLE POSTERIOR POLYAXIAL SCREW Ø:7.5 L60mm</deviceName>
    <manufacturerName>4U Makina Medikal Otomotiv Sanayi ve Ticaret Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000040424</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09070302</emdnCode>
    <emdnDescription>THORACOLUMBOSACRAL FIXATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1107560</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-04T05:49:32.181Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376509121</udiDi>
    <basicUdiDi>B-08682376509121</basicUdiDi>
    <tradeName>4U</tradeName>
    <deviceName>4U SPINAL PEDICLE POSTERIOR POLYAXIAL SCREW Ø:7.0 L60mm</deviceName>
    <manufacturerName>4U Makina Medikal Otomotiv Sanayi ve Ticaret Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000040424</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09070302</emdnCode>
    <emdnDescription>THORACOLUMBOSACRAL FIXATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1107060</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-04T05:49:31.126Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376509114</udiDi>
    <basicUdiDi>B-08682376509114</basicUdiDi>
    <tradeName>4U</tradeName>
    <deviceName>4U SPINAL PEDICLE POSTERIOR POLYAXIAL SCREW Ø:6.5 L60mm</deviceName>
    <manufacturerName>4U Makina Medikal Otomotiv Sanayi ve Ticaret Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000040424</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09070302</emdnCode>
    <emdnDescription>THORACOLUMBOSACRAL FIXATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1106560</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-04T05:49:27.122Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376509107</udiDi>
    <basicUdiDi>B-08682376509107</basicUdiDi>
    <tradeName>4U</tradeName>
    <deviceName>4U SPINAL PEDICLE POSTERIOR POLYAXIAL SCREW Ø:6.0 L60mm</deviceName>
    <manufacturerName>4U Makina Medikal Otomotiv Sanayi ve Ticaret Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000040424</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09070302</emdnCode>
    <emdnDescription>THORACOLUMBOSACRAL FIXATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1106060</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-04T05:49:26.323Z</lastUpdated>
  </row>
</eudamedExport>