<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08682376505482</udiDi>
    <basicUdiDi>B-08682376505482</basicUdiDi>
    <tradeName>08682376505482</tradeName>
    <deviceName>4U SPINAL POSTERIOR CERVICAL POLYAXIAL SCREW Ø:3.5 L26mm</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>P09070301</emdnCode>
    <emdnDescription>CERVICAL FIXATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1803526</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:36:35.119Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376505475</udiDi>
    <basicUdiDi>B-08682376505475</basicUdiDi>
    <tradeName>08682376505475</tradeName>
    <deviceName>4U SPINAL POSTERIOR CERVICAL POLYAXIAL SCREW Ø:3.5 L24mm</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>P09070301</emdnCode>
    <emdnDescription>CERVICAL FIXATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1803524</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:36:33.556Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376505468</udiDi>
    <basicUdiDi>B-08682376505468</basicUdiDi>
    <tradeName>08682376505468</tradeName>
    <deviceName>4U SPINAL POSTERIOR CERVICAL POLYAXIAL SCREW Ø:3.5 L22mm</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>P09070301</emdnCode>
    <emdnDescription>CERVICAL FIXATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1803522</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:36:31.118Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376505444</udiDi>
    <basicUdiDi>B-08682376505444</basicUdiDi>
    <tradeName>08682376505444</tradeName>
    <deviceName>4U SPINAL POSTERIOR CERVICAL POLYAXIAL SCREW Ø:3.5 L18mm</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>P09070301</emdnCode>
    <emdnDescription>CERVICAL FIXATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1803518</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:36:29.518Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376505437</udiDi>
    <basicUdiDi>B-08682376505437</basicUdiDi>
    <tradeName>08682376505437</tradeName>
    <deviceName>4U SPINAL POSTERIOR CERVICAL POLYAXIAL SCREW Ø:3.5 L16mm</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>P09070301</emdnCode>
    <emdnDescription>CERVICAL FIXATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1803516</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:36:28.716Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376505451</udiDi>
    <basicUdiDi>B-08682376505451</basicUdiDi>
    <tradeName>08682376505451</tradeName>
    <deviceName>4U SPINAL POSTERIOR CERVICAL POLYAXIAL SCREW Ø:3.5 L20mm</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>P09070301</emdnCode>
    <emdnDescription>CERVICAL FIXATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1803520</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:36:27.122Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376505420</udiDi>
    <basicUdiDi>B-08682376505420</basicUdiDi>
    <tradeName>08682376505420</tradeName>
    <deviceName>4U SPINAL POSTERIOR CERVICAL POLYAXIAL SCREW Ø:3.5 L14mm</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>P09070301</emdnCode>
    <emdnDescription>CERVICAL FIXATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1803514</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:36:23.917Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376505413</udiDi>
    <basicUdiDi>B-08682376505413</basicUdiDi>
    <tradeName>08682376505413</tradeName>
    <deviceName>4U SPINAL POSTERIOR CERVICAL POLYAXIAL SCREW Ø:3.5 L12mm</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>P09070301</emdnCode>
    <emdnDescription>CERVICAL FIXATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1803512</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:36:08.650Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376505406</udiDi>
    <basicUdiDi>B-08682376505406</basicUdiDi>
    <tradeName>08682376505406</tradeName>
    <deviceName>4U SPINAL POSTERIOR CERVICAL POLYAXIAL SCREW Ø:3.5 L10mm</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>P09070301</emdnCode>
    <emdnDescription>CERVICAL FIXATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1803510</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:36:07.849Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376505390</udiDi>
    <basicUdiDi>B-08682376505390</basicUdiDi>
    <tradeName>08682376505390</tradeName>
    <deviceName>4U SPINAL INTERSPINOUS U DEVICE 16mm</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>8800016</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:36:07.145Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376505383</udiDi>
    <basicUdiDi>B-08682376505383</basicUdiDi>
    <tradeName>08682376505383</tradeName>
    <deviceName>4U SPINAL INTERSPINOUS U DEVICE 14mm</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>8800014</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:36:05.456Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376505376</udiDi>
    <basicUdiDi>B-08682376505376</basicUdiDi>
    <tradeName>08682376505376</tradeName>
    <deviceName>4U SPINAL INTERSPINOUS U DEVICE 12mm</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>8800012</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:36:01.438Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376505369</udiDi>
    <basicUdiDi>B-08682376505369</basicUdiDi>
    <tradeName>08682376505369</tradeName>
    <deviceName>4U SPINAL INTERSPINOUS U DEVICE 10mm</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>8800010</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:36:00.643Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376505352</udiDi>
    <basicUdiDi>B-08682376505352</basicUdiDi>
    <tradeName>08682376505352</tradeName>
    <deviceName>4U SPINAL INTERSPINOUS U DEVICE 8mm</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>8800008</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:35:59.848Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376505345</udiDi>
    <basicUdiDi>B-08682376505345</basicUdiDi>
    <tradeName>08682376505345</tradeName>
    <deviceName>4U SPINAL MULTIAXIAL  CONNECTOR</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>P09070304</emdnCode>
    <emdnDescription>SPINE FIXATION SYSTEM CONNECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2700050</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:35:59.055Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376505338</udiDi>
    <basicUdiDi>B-08682376505338</basicUdiDi>
    <tradeName>08682376505338</tradeName>
    <deviceName>4U SPINAL DOMINO CONNECTOR</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>P09070304</emdnCode>
    <emdnDescription>SPINE FIXATION SYSTEM CONNECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2700040</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:35:55.034Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376505321</udiDi>
    <basicUdiDi>B-08682376505321</basicUdiDi>
    <tradeName>08682376505321</tradeName>
    <deviceName>4U SPINAL AXIAL CONNECTOR</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>P09070304</emdnCode>
    <emdnDescription>SPINE FIXATION SYSTEM CONNECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2700030</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:35:54.233Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376505314</udiDi>
    <basicUdiDi>B-08682376505314</basicUdiDi>
    <tradeName>08682376505314</tradeName>
    <deviceName>4U SPINAL LATERAL CONNECTOR 20 mm</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>P09070304</emdnCode>
    <emdnDescription>SPINE FIXATION SYSTEM CONNECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2700020</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:35:53.431Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376505307</udiDi>
    <basicUdiDi>B-08682376505307</basicUdiDi>
    <tradeName>08682376505307</tradeName>
    <deviceName>4U SPINAL LATERAL CONNECTOR 15 mm</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>P09070304</emdnCode>
    <emdnDescription>SPINE FIXATION SYSTEM CONNECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2700015</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:35:52.643Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376505284</udiDi>
    <basicUdiDi>B-08682376505284</basicUdiDi>
    <tradeName>08682376505284</tradeName>
    <deviceName>4U SPINAL MULTIAXIAL TRANSVERSE CONNECTOR 50 mm</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>P09070304</emdnCode>
    <emdnDescription>SPINE FIXATION SYSTEM CONNECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2600050</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:35:47.825Z</lastUpdated>
  </row>
</eudamedExport>