<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08682376507851</udiDi>
    <basicUdiDi>B-08682376507851</basicUdiDi>
    <tradeName>08682376507851</tradeName>
    <deviceName>4U SPINAL PEDICLE POSTERIOR POLYAXIAL CANNULATED SCREW Ø:5.5  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>1605540</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:37:08.734Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376507844</udiDi>
    <basicUdiDi>B-08682376507844</basicUdiDi>
    <tradeName>08682376507844</tradeName>
    <deviceName>4U SPINAL PEDICLE POSTERIOR POLYAXIAL CANNULATED SCREW Ø:5.5  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>1605535</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:37:07.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376507837</udiDi>
    <basicUdiDi>B-08682376507837</basicUdiDi>
    <tradeName>08682376507837</tradeName>
    <deviceName>4U SPINAL PEDICLE POSTERIOR POLYAXIAL CANNULATED SCREW Ø:5.5  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>1605530</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:37:04.731Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376505659</udiDi>
    <basicUdiDi>B-08682376505659</basicUdiDi>
    <tradeName>08682376505659</tradeName>
    <deviceName>4U SPINAL POSTERIOR CERVICAL ROD Ø:3.5 L:200mm</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>2403200</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:37:03.128Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376505642</udiDi>
    <basicUdiDi>B-08682376505642</basicUdiDi>
    <tradeName>08682376505642</tradeName>
    <deviceName>4U SPINAL POSTERIOR CERVICAL ROD Ø:3.5 L:120mm</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>2403120</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:37:02.331Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376505635</udiDi>
    <basicUdiDi>B-08682376505635</basicUdiDi>
    <tradeName>08682376505635</tradeName>
    <deviceName>4U SPINAL POSTERIOR CERVICAL ROD Ø:3.5 L:80mm</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>2400380</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:37:00.724Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376505628</udiDi>
    <basicUdiDi>B-08682376505628</basicUdiDi>
    <tradeName>08682376505628</tradeName>
    <deviceName>4U SPINAL POSTERIOR CERVICAL ROD Ø:3.5 L:40mm</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>2400340</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:36:57.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376505611</udiDi>
    <basicUdiDi>B-08682376505611</basicUdiDi>
    <tradeName>08682376505611</tradeName>
    <deviceName>4U SPINAL POSTERIOR CERVICAL 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>P09070301</emdnCode>
    <emdnDescription>CERVICAL FIXATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1804030</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:36:55.939Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376505604</udiDi>
    <basicUdiDi>B-08682376505604</basicUdiDi>
    <tradeName>08682376505604</tradeName>
    <deviceName>4U SPINAL POSTERIOR CERVICAL POLYAXIAL SCREW Ø:4.0 L28mm</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>1804028</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:36:55.129Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376505598</udiDi>
    <basicUdiDi>B-08682376505598</basicUdiDi>
    <tradeName>08682376505598</tradeName>
    <deviceName>4U SPINAL POSTERIOR CERVICAL POLYAXIAL SCREW Ø:4.0 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>1804026</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:36:53.526Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376505581</udiDi>
    <basicUdiDi>B-08682376505581</basicUdiDi>
    <tradeName>08682376505581</tradeName>
    <deviceName>4U SPINAL POSTERIOR CERVICAL POLYAXIAL SCREW Ø:4.0 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>1804024</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:36:51.127Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376505574</udiDi>
    <basicUdiDi>B-08682376505574</basicUdiDi>
    <tradeName>08682376505574</tradeName>
    <deviceName>4U SPINAL POSTERIOR CERVICAL POLYAXIAL SCREW Ø:4.0 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>1804022</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:36:49.520Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376505567</udiDi>
    <basicUdiDi>B-08682376505567</basicUdiDi>
    <tradeName>08682376505567</tradeName>
    <deviceName>4U SPINAL POSTERIOR CERVICAL POLYAXIAL SCREW Ø:4.0 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>1804020</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:36:48.724Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376505550</udiDi>
    <basicUdiDi>B-08682376505550</basicUdiDi>
    <tradeName>08682376505550</tradeName>
    <deviceName>4U SPINAL POSTERIOR CERVICAL POLYAXIAL SCREW Ø:4.0 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>1804018</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:36:47.127Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376505543</udiDi>
    <basicUdiDi>B-08682376505543</basicUdiDi>
    <tradeName>08682376505543</tradeName>
    <deviceName>4U SPINAL POSTERIOR CERVICAL POLYAXIAL SCREW Ø:4.0 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>1804016</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:36:44.723Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376505536</udiDi>
    <basicUdiDi>B-08682376505536</basicUdiDi>
    <tradeName>08682376505536</tradeName>
    <deviceName>4U SPINAL POSTERIOR CERVICAL POLYAXIAL SCREW Ø:4.0 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>1804014</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:36:43.142Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376505529</udiDi>
    <basicUdiDi>B-08682376505529</basicUdiDi>
    <tradeName>08682376505529</tradeName>
    <deviceName>4U SPINAL POSTERIOR CERVICAL POLYAXIAL SCREW Ø:4.0 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>1804012</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:36:42.419Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376505512</udiDi>
    <basicUdiDi>B-08682376505512</basicUdiDi>
    <tradeName>08682376505512</tradeName>
    <deviceName>4U SPINAL POSTERIOR CERVICAL POLYAXIAL SCREW Ø:4.0 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>1804010</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:36:39.926Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376505505</udiDi>
    <basicUdiDi>B-08682376505505</basicUdiDi>
    <tradeName>08682376505505</tradeName>
    <deviceName>4U SPINAL POSTERIOR CERVICAL POLYAXIAL SCREW Ø:3.5 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>P09070301</emdnCode>
    <emdnDescription>CERVICAL FIXATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1803530</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:36:37.533Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682376505499</udiDi>
    <basicUdiDi>B-08682376505499</basicUdiDi>
    <tradeName>08682376505499</tradeName>
    <deviceName>4U SPINAL POSTERIOR CERVICAL POLYAXIAL SCREW Ø:3.5 L28mm</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>1803528</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:36:35.918Z</lastUpdated>
  </row>
</eudamedExport>