<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>
  <row>
    <udiDi>08682376509091</udiDi>
    <basicUdiDi>B-08682376509091</basicUdiDi>
    <tradeName>4U</tradeName>
    <deviceName>4U SPINAL PEDICLE POSTERIOR POLYAXIAL SCREW Ø:6.0 L30mm</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>1106030</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-04T05:49:25.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376509084</udiDi>
    <basicUdiDi>B-08682376509084</basicUdiDi>
    <tradeName>4U</tradeName>
    <deviceName>4U SPINAL PEDICLE POSTERIOR POLYAXIAL SCREW Ø:5.5 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>1105560</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-04T05:49:24.734Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376509046</udiDi>
    <basicUdiDi>B-08682376509046</basicUdiDi>
    <tradeName>4U</tradeName>
    <deviceName>4U SPINAL PEDICLE POSTERIOR POLYAXIAL SCREW Ø:4.0 L45mm</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>1104045</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-04T05:49:20.726Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376509022</udiDi>
    <basicUdiDi>B-08682376509022</basicUdiDi>
    <tradeName>4U</tradeName>
    <deviceName>4U SPINAL PEDICLE POSTERIOR POLYAXIAL SCREW Ø:4.0 L35mm</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>1104035</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-04T05:49:19.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376509015</udiDi>
    <basicUdiDi>B-08682376509015</basicUdiDi>
    <tradeName>4U</tradeName>
    <deviceName>4U SPINAL PEDICLE POSTERIOR POLYAXIAL SCREW Ø:4.0 L30mm</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>1104030</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-04T05:49:19.119Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376509039</udiDi>
    <basicUdiDi>B-08682376509039</basicUdiDi>
    <tradeName>4U</tradeName>
    <deviceName>4U SPINAL PEDICLE POSTERIOR POLYAXIAL SCREW Ø:4.0 L40mm</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>1104040</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-04T05:49:18.341Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376509008</udiDi>
    <basicUdiDi>B-08682376509008</basicUdiDi>
    <tradeName>4U</tradeName>
    <deviceName>4U SPINAL PEDICLE POSTERIOR POLYAXIAL SCREW Ø:4.0 L25mm</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>1104025</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-04T05:49:03.197Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376500760</udiDi>
    <basicUdiDi>B-08682376500760</basicUdiDi>
    <tradeName>4U</tradeName>
    <deviceName>4U SPINAL PEDICLE POSTERIOR POLYAXIAL SCREW Ø:8.0 L55mm</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>1108055</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-04T05:49:00.676Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376500753</udiDi>
    <basicUdiDi>B-08682376500753</basicUdiDi>
    <tradeName>4U</tradeName>
    <deviceName>4U SPINAL PEDICLE POSTERIOR POLYAXIAL SCREW Ø:8.0 L50mm</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>1108050</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-04T05:48:59.071Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376500746</udiDi>
    <basicUdiDi>B-08682376500746</basicUdiDi>
    <tradeName>4U</tradeName>
    <deviceName>4U SPINAL PEDICLE POSTERIOR POLYAXIAL SCREW Ø:8.0 L45mm</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>1108045</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-04T05:48:58.286Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376500739</udiDi>
    <basicUdiDi>B-08682376500739</basicUdiDi>
    <tradeName>4U</tradeName>
    <deviceName>4U SPINAL PEDICLE POSTERIOR POLYAXIAL SCREW Ø:8.0 L40mm</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>1108040</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-04T05:48:56.743Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376500722</udiDi>
    <basicUdiDi>B-08682376500722</basicUdiDi>
    <tradeName>4U</tradeName>
    <deviceName>4U SPINAL PEDICLE POSTERIOR POLYAXIAL SCREW Ø:8.0 L35mm</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>1108035</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-04T05:48:54.283Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376500715</udiDi>
    <basicUdiDi>B-08682376500715</basicUdiDi>
    <tradeName>4U</tradeName>
    <deviceName>4U SPINAL PEDICLE POSTERIOR POLYAXIAL SCREW Ø:8.0 L30mm</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>1108030</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-04T05:48:52.668Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376500616</udiDi>
    <basicUdiDi>B-08682376500616</basicUdiDi>
    <tradeName>4U</tradeName>
    <deviceName>4U SPINAL PEDICLE POSTERIOR POLYAXIAL SCREW Ø:7.5 L55mm</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>1107555</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-04T05:48:52.002Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376500609</udiDi>
    <basicUdiDi>B-08682376500609</basicUdiDi>
    <tradeName>4U</tradeName>
    <deviceName>4U SPINAL PEDICLE POSTERIOR POLYAXIAL SCREW Ø:7.5 L50mm</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>1107550</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-04T05:48:49.457Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376500593</udiDi>
    <basicUdiDi>B-08682376500593</basicUdiDi>
    <tradeName>4U</tradeName>
    <deviceName>4U SPINAL PEDICLE POSTERIOR POLYAXIAL SCREW Ø:7.5 L45mm</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>1107545</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-04T05:48:47.055Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376500586</udiDi>
    <basicUdiDi>B-08682376500586</basicUdiDi>
    <tradeName>4U</tradeName>
    <deviceName>4U SPINAL PEDICLE POSTERIOR POLYAXIAL SCREW Ø:7.5 L40mm</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>1107540</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-04T05:48:45.447Z</lastUpdated>
  </row>
</eudamedExport>