<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>03701313000776</udiDi>
    <basicUdiDi>B-03701313000776</basicUdiDi>
    <tradeName>KHEIRON</tradeName>
    <deviceName>Vis pédiculaire Ø4.5 L40mm</deviceName>
    <manufacturerName>S.M.A.I.O</manufacturerName>
    <manufacturerSrn>FR-MF-000002399</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09070302</emdnCode>
    <emdnDescription>THORACOLUMBOSACRAL FIXATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24PW45040</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T17:01:03.761Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701313000769</udiDi>
    <basicUdiDi>B-03701313000769</basicUdiDi>
    <tradeName>KHEIRON</tradeName>
    <deviceName>Vis pédiculaire Ø4.5 L35mm</deviceName>
    <manufacturerName>S.M.A.I.O</manufacturerName>
    <manufacturerSrn>FR-MF-000002399</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09070302</emdnCode>
    <emdnDescription>THORACOLUMBOSACRAL FIXATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24PW45035</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T17:01:02.955Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701313000752</udiDi>
    <basicUdiDi>B-03701313000752</basicUdiDi>
    <tradeName>KHEIRON</tradeName>
    <deviceName>Vis pédiculaire Ø4.5 L30mm</deviceName>
    <manufacturerName>S.M.A.I.O</manufacturerName>
    <manufacturerSrn>FR-MF-000002399</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09070302</emdnCode>
    <emdnDescription>THORACOLUMBOSACRAL FIXATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24PW45030</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T17:01:02.151Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701313000745</udiDi>
    <basicUdiDi>B-03701313000745</basicUdiDi>
    <tradeName>KHEIRON</tradeName>
    <deviceName>Vis pédiculaire Ø4.5 L25mm</deviceName>
    <manufacturerName>S.M.A.I.O</manufacturerName>
    <manufacturerSrn>FR-MF-000002399</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09070302</emdnCode>
    <emdnDescription>THORACOLUMBOSACRAL FIXATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24PW45025</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T17:00:58.162Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701313000462</udiDi>
    <basicUdiDi>B-03701313000462</basicUdiDi>
    <tradeName>KHEIRON</tradeName>
    <deviceName>Ø6 patient-specific K-ROD Ti rod</deviceName>
    <manufacturerName>S.M.A.I.O</manufacturerName>
    <manufacturerSrn>FR-MF-000002399</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09070199</emdnCode>
    <emdnDescription>SPINAL FUSION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>32KR60000</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T17:00:57.347Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701313000455</udiDi>
    <basicUdiDi>B-03701313000455</basicUdiDi>
    <tradeName>KHEIRON</tradeName>
    <deviceName>Ø5.5 patient-specific K-ROD Ti rod</deviceName>
    <manufacturerName>S.M.A.I.O</manufacturerName>
    <manufacturerSrn>FR-MF-000002399</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09070199</emdnCode>
    <emdnDescription>SPINAL FUSION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>32KR55000</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T17:00:56.557Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701313000448</udiDi>
    <basicUdiDi>B-03701313000448</basicUdiDi>
    <tradeName>KHEIRON</tradeName>
    <deviceName>Pousse-extension iliaque</deviceName>
    <manufacturerName>S.M.A.I.O</manufacturerName>
    <manufacturerSrn>FR-MF-000002399</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0999</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01PE2010</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T17:00:55.750Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701313000431</udiDi>
    <basicUdiDi>B-03701313000431</basicUdiDi>
    <tradeName>KHEIRON</tradeName>
    <deviceName>Sonde pédiculaire lombaire courbe</deviceName>
    <manufacturerName>S.M.A.I.O</manufacturerName>
    <manufacturerSrn>FR-MF-000002399</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L031199</emdnCode>
    <emdnDescription>PROBES AND MIRRORS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01PB1025</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T17:00:51.754Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701313000424</udiDi>
    <basicUdiDi>B-03701313000424</basicUdiDi>
    <tradeName>KHEIRON</tradeName>
    <deviceName>Sonde pédiculaire lombaire droite</deviceName>
    <manufacturerName>S.M.A.I.O</manufacturerName>
    <manufacturerSrn>FR-MF-000002399</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L031199</emdnCode>
    <emdnDescription>PROBES AND MIRRORS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01PB1015</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T17:00:50.944Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701313000417</udiDi>
    <basicUdiDi>B-03701313000417</basicUdiDi>
    <tradeName>KHEIRON</tradeName>
    <deviceName>Porte-crochet lamaire droit</deviceName>
    <manufacturerName>S.M.A.I.O</manufacturerName>
    <manufacturerSrn>FR-MF-000002399</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0999</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01HH2035</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T17:00:50.139Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701313000400</udiDi>
    <basicUdiDi>B-03701313000400</basicUdiDi>
    <tradeName>KHEIRON</tradeName>
    <deviceName>Porte-extension iliaque</deviceName>
    <manufacturerName>S.M.A.I.O</manufacturerName>
    <manufacturerSrn>FR-MF-000002399</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0999</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01HE2010</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T17:00:49.349Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701313000349</udiDi>
    <basicUdiDi>B-03701313000349</basicUdiDi>
    <tradeName>KHEIRON</tradeName>
    <deviceName>Guide pour bouchon S2 droite 90° pour plaque sacrée L</deviceName>
    <manufacturerName>S.M.A.I.O</manufacturerName>
    <manufacturerSrn>FR-MF-000002399</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0922</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY GUIDES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01GN2050</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T17:00:45.344Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701313000332</udiDi>
    <basicUdiDi>B-03701313000332</basicUdiDi>
    <tradeName>KHEIRON</tradeName>
    <deviceName>Guide pour bouchon S2 gauche 90° pour plaque sacrée L</deviceName>
    <manufacturerName>S.M.A.I.O</manufacturerName>
    <manufacturerSrn>FR-MF-000002399</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0922</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY GUIDES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01GN2060</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T17:00:44.543Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701313000394</udiDi>
    <basicUdiDi>B-03701313000394</basicUdiDi>
    <tradeName>KHEIRON</tradeName>
    <deviceName>Contre-couple pour contre-crochet</deviceName>
    <manufacturerName>S.M.A.I.O</manufacturerName>
    <manufacturerSrn>FR-MF-000002399</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0999</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01CH4010</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T17:00:43.745Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701313000356</udiDi>
    <basicUdiDi>B-03701313000356</basicUdiDi>
    <tradeName>KHEIRON</tradeName>
    <deviceName>Tournevis pédiculaire long</deviceName>
    <manufacturerName>S.M.A.I.O</manufacturerName>
    <manufacturerSrn>FR-MF-000002399</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L26</emdnCode>
    <emdnDescription>SURGICAL SCREWDRIVERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01DS2025</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T17:00:43.056Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701313000325</udiDi>
    <basicUdiDi>B-03701313000325</basicUdiDi>
    <tradeName>KHEIRON</tradeName>
    <deviceName>Guide pour bouchon S2 droite 60° pour plaque sacrée L</deviceName>
    <manufacturerName>S.M.A.I.O</manufacturerName>
    <manufacturerSrn>FR-MF-000002399</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0922</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY GUIDES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01GN2070</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T17:00:26.082Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701313000318</udiDi>
    <basicUdiDi>B-03701313000318</basicUdiDi>
    <tradeName>KHEIRON</tradeName>
    <deviceName>Guide pour bouchon S2 gauche 60° pour plaque sacrée L</deviceName>
    <manufacturerName>S.M.A.I.O</manufacturerName>
    <manufacturerSrn>FR-MF-000002399</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0922</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY GUIDES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01GN2080</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T17:00:25.285Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701313000295</udiDi>
    <basicUdiDi>B-03701313000295</basicUdiDi>
    <tradeName>KHEIRON</tradeName>
    <deviceName>Porte-tige coudé</deviceName>
    <manufacturerName>S.M.A.I.O</manufacturerName>
    <manufacturerSrn>FR-MF-000002399</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0999</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01HR2020</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T17:00:24.485Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701313000288</udiDi>
    <basicUdiDi>B-03701313000288</basicUdiDi>
    <tradeName>KHEIRON</tradeName>
    <deviceName>Porte-tige coudé long</deviceName>
    <manufacturerName>S.M.A.I.O</manufacturerName>
    <manufacturerSrn>FR-MF-000002399</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0999</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01HR2030</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T17:00:23.681Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701313000271</udiDi>
    <basicUdiDi>B-03701313000271</basicUdiDi>
    <tradeName>KHEIRON</tradeName>
    <deviceName>Clip temporaire pour tige</deviceName>
    <manufacturerName>S.M.A.I.O</manufacturerName>
    <manufacturerSrn>FR-MF-000002399</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0999</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01HR2040</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T17:00:19.677Z</lastUpdated>
  </row>
</eudamedExport>