<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00851797006863</udiDi>
    <basicUdiDi>8430591REUSABLECABLEUZ</basicUdiDi>
    <tradeName>LIGHT CABLE, STANDARD CURVE, 10'</tradeName>
    <deviceName>REUSABLE CABLE</deviceName>
    <manufacturerName>TeDan Surgical Innovations, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016933</manufacturerSrn>
    <authorisedRepresentativeName>TeDan Surgical Innovations B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002696</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ML-0045</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:21:04.457Z</lastUpdated>
  </row>
  <row>
    <udiDi>00843059127904</udiDi>
    <basicUdiDi>8430591CAMERAHOLDER59</basicUdiDi>
    <tradeName>SPY-PHI Articulating Arm, Imaging Head Holder</tradeName>
    <deviceName>Camera Holder</deviceName>
    <manufacturerName>TeDan Surgical Innovations, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016933</manufacturerSrn>
    <authorisedRepresentativeName>TeDan Surgical Innovations B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002696</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0318</emdnCode>
    <emdnDescription>INSTRUMENTS FOR SUPPORT OF SURGICAL DEVICES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HH1003</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:21:02.745Z</lastUpdated>
  </row>
  <row>
    <udiDi>00843059126242</udiDi>
    <basicUdiDi>8430591STERILECABLE4M</basicUdiDi>
    <tradeName>LIGHT CABLE, 10’, STERILE, 1/BOX</tradeName>
    <deviceName>STERILE LIGHT CABLE</deviceName>
    <manufacturerName>TeDan Surgical Innovations, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016933</manufacturerSrn>
    <authorisedRepresentativeName>TeDan Surgical Innovations B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002696</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VPR0046</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:21:01.897Z</lastUpdated>
  </row>
  <row>
    <udiDi>00843059105896</udiDi>
    <basicUdiDi>8430591TAMP68</basicUdiDi>
    <tradeName>BONE TAMP, 6 X 10 MM</tradeName>
    <deviceName>TAMP</deviceName>
    <manufacturerName>TeDan Surgical Innovations, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016933</manufacturerSrn>
    <authorisedRepresentativeName>TeDan Surgical Innovations B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002696</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS-0121</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:21:00.255Z</lastUpdated>
  </row>
  <row>
    <udiDi>00843059113280</udiDi>
    <basicUdiDi>8430591INTRODUCERKJ</basicUdiDi>
    <tradeName>DILATOR, 8 MM, SILVER</tradeName>
    <deviceName>INTRODUCER</deviceName>
    <manufacturerName>TeDan Surgical Innovations, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016933</manufacturerSrn>
    <authorisedRepresentativeName>TeDan Surgical Innovations B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002696</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L070802</emdnCode>
    <emdnDescription>VASCULAR DILATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ML-0310</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:20:57.711Z</lastUpdated>
  </row>
  <row>
    <udiDi>00843059107173</udiDi>
    <basicUdiDi>8430591BLADEHANDLE3V</basicUdiDi>
    <tradeName>CONICAL RETRACTOR BLADE HANDLE</tradeName>
    <deviceName>BLADE HANDLE</deviceName>
    <manufacturerName>TeDan Surgical Innovations, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016933</manufacturerSrn>
    <authorisedRepresentativeName>TeDan Surgical Innovations B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002696</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS-0325</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:20:56.908Z</lastUpdated>
  </row>
  <row>
    <udiDi>00843059105889</udiDi>
    <basicUdiDi>8430591CALIPERSY</basicUdiDi>
    <tradeName>CALIPER</tradeName>
    <deviceName>CALIPERS</deviceName>
    <manufacturerName>TeDan Surgical Innovations, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016933</manufacturerSrn>
    <authorisedRepresentativeName>TeDan Surgical Innovations B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002696</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V030201</emdnCode>
    <emdnDescription>CALIPERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS-0120</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:20:56.133Z</lastUpdated>
  </row>
  <row>
    <udiDi>00843059105872</udiDi>
    <basicUdiDi>8430591DRILLGUIDE7Z</basicUdiDi>
    <tradeName>SINGLE DRILL GUIDE</tradeName>
    <deviceName>DRILL GUIDE</deviceName>
    <manufacturerName>TeDan Surgical Innovations, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016933</manufacturerSrn>
    <authorisedRepresentativeName>TeDan Surgical Innovations B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002696</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS-0119</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:20:52.106Z</lastUpdated>
  </row>
  <row>
    <udiDi>00843059105834</udiDi>
    <basicUdiDi>8430591DISTRACTORBQ</basicUdiDi>
    <tradeName>ACF DISTRACTOR, LEFT, 120 MM RACK</tradeName>
    <deviceName>DISTRACTOR</deviceName>
    <manufacturerName>TeDan Surgical Innovations, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016933</manufacturerSrn>
    <authorisedRepresentativeName>TeDan Surgical Innovations B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002696</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0920</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY DISTRACTORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS-0115</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:20:51.305Z</lastUpdated>
  </row>
  <row>
    <udiDi>00843059105827</udiDi>
    <basicUdiDi>8430591SCREWDRIVER8R</basicUdiDi>
    <tradeName>DISTRACTION SCREWDRIVER, SPRINGLESS</tradeName>
    <deviceName>SCREWDRIVER</deviceName>
    <manufacturerName>TeDan Surgical Innovations, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016933</manufacturerSrn>
    <authorisedRepresentativeName>TeDan Surgical Innovations B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002696</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS-0114</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:20:50.502Z</lastUpdated>
  </row>
  <row>
    <udiDi>00843059105803</udiDi>
    <basicUdiDi>8430591TWISTDRILLYK</basicUdiDi>
    <tradeName>TWIST DRILL</tradeName>
    <deviceName>TWIST DRILL</deviceName>
    <manufacturerName>TeDan Surgical Innovations, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016933</manufacturerSrn>
    <authorisedRepresentativeName>TeDan Surgical Innovations B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002696</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS-0112</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:20:49.710Z</lastUpdated>
  </row>
  <row>
    <udiDi>00843059105766</udiDi>
    <basicUdiDi>8430591DEPTHGAUGE38</basicUdiDi>
    <tradeName>CERVICAL DEPTH GAUGE</tradeName>
    <deviceName>DEPTH GAUGE</deviceName>
    <manufacturerName>TeDan Surgical Innovations, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016933</manufacturerSrn>
    <authorisedRepresentativeName>TeDan Surgical Innovations B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002696</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS-0106</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:20:45.702Z</lastUpdated>
  </row>
  <row>
    <udiDi>00843059105261</udiDi>
    <basicUdiDi>8430591RETRACTORBLADED8</basicUdiDi>
    <tradeName>CONICAL PADDLE BLADE, 20 X 55 MM, BLACK</tradeName>
    <deviceName>RETRACTOR BLADE</deviceName>
    <manufacturerName>TeDan Surgical Innovations, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016933</manufacturerSrn>
    <authorisedRepresentativeName>TeDan Surgical Innovations B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002696</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0199</emdnCode>
    <emdnDescription>SHARP INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS-0040C</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:20:44.908Z</lastUpdated>
  </row>
  <row>
    <udiDi>00843059104424</udiDi>
    <basicUdiDi>8430591ADAPTERRH</basicUdiDi>
    <tradeName>PHANTOM ML ACMI ADAPTER</tradeName>
    <deviceName>Adapter</deviceName>
    <manufacturerName>TeDan Surgical Innovations, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016933</manufacturerSrn>
    <authorisedRepresentativeName>TeDan Surgical Innovations B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002696</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020402</emdnCode>
    <emdnDescription>LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>48851313B</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:20:44.113Z</lastUpdated>
  </row>
  <row>
    <udiDi>00843059100792</udiDi>
    <basicUdiDi>8430591RETRACTORTH</basicUdiDi>
    <tradeName>LATERAL 3 BLADED RETRACTOR</tradeName>
    <deviceName>RETRACTOR</deviceName>
    <manufacturerName>TeDan Surgical Innovations, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016933</manufacturerSrn>
    <authorisedRepresentativeName>TeDan Surgical Innovations B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002696</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L03140199</emdnCode>
    <emdnDescription>SPREADERS AND RETRACTORS FOR GENERAL SURGERY, REUSABLE   - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ML-0905</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:20:43.317Z</lastUpdated>
  </row>
  <row>
    <udiDi>00843059100075</udiDi>
    <basicUdiDi>8430591CLAMPVH</basicUdiDi>
    <tradeName>POST CLAMP</tradeName>
    <deviceName>Clamp</deviceName>
    <manufacturerName>TeDan Surgical Innovations, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016933</manufacturerSrn>
    <authorisedRepresentativeName>TeDan Surgical Innovations B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002696</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L1299</emdnCode>
    <emdnDescription>LAPAROSCOPIC AND THORACOSCOPIC INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TK-0604</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:20:39.298Z</lastUpdated>
  </row>
  <row>
    <udiDi>00843059100051</udiDi>
    <basicUdiDi>8430591TRAY8B</basicUdiDi>
    <tradeName>INSTRUMENT TRAY, TK-6000</tradeName>
    <deviceName>TRAY</deviceName>
    <manufacturerName>TeDan Surgical Innovations, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016933</manufacturerSrn>
    <authorisedRepresentativeName>TeDan Surgical Innovations B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002696</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S010401</emdnCode>
    <emdnDescription>TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TK-0600</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:20:38.493Z</lastUpdated>
  </row>
  <row>
    <udiDi>00843059100006</udiDi>
    <basicUdiDi>8430591ARMF8</basicUdiDi>
    <tradeName>U-BAR, REAR</tradeName>
    <deviceName>ARM</deviceName>
    <manufacturerName>TeDan Surgical Innovations, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016933</manufacturerSrn>
    <authorisedRepresentativeName>TeDan Surgical Innovations B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002696</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L1199</emdnCode>
    <emdnDescription>NEUROSURGERY INSTRUMENTS, REUSABLE- OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TK-0316</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:20:37.695Z</lastUpdated>
  </row>
  <row>
    <udiDi>00843059127911</udiDi>
    <basicUdiDi>8430591CLAMPVH</basicUdiDi>
    <tradeName>AXS Table Clamp - Rotatable, Stainless Steel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TeDan Surgical Innovations, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016933</manufacturerSrn>
    <authorisedRepresentativeName>TeDan Surgical Innovations B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002696</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L1299</emdnCode>
    <emdnDescription>LAPAROSCOPIC AND THORACOSCOPIC INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AA-0204</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:49:08.490Z</lastUpdated>
  </row>
  <row>
    <udiDi>00843059127898</udiDi>
    <basicUdiDi>8430591CLAMPVH</basicUdiDi>
    <tradeName>SPY-PHI Articulating Arm, Table Clamp</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TeDan Surgical Innovations, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016933</manufacturerSrn>
    <authorisedRepresentativeName>TeDan Surgical Innovations B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002696</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L1299</emdnCode>
    <emdnDescription>LAPAROSCOPIC AND THORACOSCOPIC INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HH1002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:49:06.377Z</lastUpdated>
  </row>
</eudamedExport>