<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04719874672355</udiDi>
    <basicUdiDi>471987675DR0001F6</basicUdiDi>
    <tradeName>aZure Lance Drill, 1.8mm</tradeName>
    <deviceName>Drill</deviceName>
    <manufacturerName>INTAI Technology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000001158</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK00058</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:46:10.332Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719874672843</udiDi>
    <basicUdiDi>471987675DR0002F8</basicUdiDi>
    <tradeName>aZure Handpiece Implant Driver, Small, Short</tradeName>
    <deviceName>Implant Driver</deviceName>
    <manufacturerName>INTAI Technology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000001158</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK00065</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:39:08.605Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719874672331</udiDi>
    <basicUdiDi>471987675DR0001F6</basicUdiDi>
    <tradeName>aZure Lance Drill, 2mm</tradeName>
    <deviceName>Drill</deviceName>
    <manufacturerName>INTAI Technology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000001158</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK00002</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:39:07.802Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260525167886</udiDi>
    <basicUdiDi>426052516ThreadTap97</basicUdiDi>
    <tradeName>IH Thread Tap</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEDIGMA BIOMEDICAL GMBH</manufacturerName>
    <manufacturerSrn>DE-MF-000009412</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MIH9045</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:27:04.799Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260525166766</udiDi>
    <basicUdiDi>426052516ThreadTap97</basicUdiDi>
    <tradeName>SD Thread Tap</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEDIGMA BIOMEDICAL GMBH</manufacturerName>
    <manufacturerSrn>DE-MF-000009412</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSD9045</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:19:20.020Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260525165592</udiDi>
    <basicUdiDi>426052516ThreadTap97</basicUdiDi>
    <tradeName>ND Thread Tap</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEDIGMA BIOMEDICAL GMBH</manufacturerName>
    <manufacturerSrn>DE-MF-000009412</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MND9045</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T23:08:32.595Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250539938053</udiDi>
    <basicUdiDi>42505399195NR</basicUdiDi>
    <tradeName>SAMSON</tradeName>
    <deviceName>SA Inserter Handle</deviceName>
    <manufacturerName>HumanTech Spine GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010596</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2000040000-4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:41:01.896Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250539937698</udiDi>
    <basicUdiDi>42505399304N6</basicUdiDi>
    <tradeName>VENUS</tradeName>
    <deviceName>VE MIS Assembling Tool</deviceName>
    <manufacturerName>HumanTech Spine GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010596</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4008010008</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:41:01.104Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250539937674</udiDi>
    <basicUdiDi>42505399303N4</basicUdiDi>
    <tradeName>VENUS</tradeName>
    <deviceName>VE Measure</deviceName>
    <manufacturerName>HumanTech Spine GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010596</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4008010006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:41:00.309Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250539937667</udiDi>
    <basicUdiDi>42505399302N2</basicUdiDi>
    <tradeName>VENUS</tradeName>
    <deviceName>VE Counter Handle</deviceName>
    <manufacturerName>HumanTech Spine GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010596</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4008010005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:40:59.500Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250539937636</udiDi>
    <basicUdiDi>42505399299P6</basicUdiDi>
    <tradeName>VENUS</tradeName>
    <deviceName>VE MIS Multitool</deviceName>
    <manufacturerName>HumanTech Spine GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010596</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4008010002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:40:55.517Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250539936844</udiDi>
    <basicUdiDi>42505399297P2</basicUdiDi>
    <tradeName>VENUSnano</tradeName>
    <deviceName>VN Handle</deviceName>
    <manufacturerName>HumanTech Spine GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010596</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2200010062</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:40:54.782Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250539936769</udiDi>
    <basicUdiDi>42505399296NY</basicUdiDi>
    <tradeName>VENUSnano</tradeName>
    <deviceName>VN Torque Driver</deviceName>
    <manufacturerName>HumanTech Spine GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010596</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2200010054</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:40:53.890Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250539936431</udiDi>
    <basicUdiDi>42505399275NQ</basicUdiDi>
    <tradeName>VENUSnano</tradeName>
    <deviceName>VN Bender</deviceName>
    <manufacturerName>HumanTech Spine GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010596</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2200010018</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:40:53.100Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250539934772</udiDi>
    <basicUdiDi>42505399148NG</basicUdiDi>
    <tradeName>ADONIS</tradeName>
    <deviceName>AD Handle</deviceName>
    <manufacturerName>HumanTech Spine GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010596</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1701010600</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:40:49.100Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250539934062</udiDi>
    <basicUdiDi>42505399340NA</basicUdiDi>
    <tradeName>TRISTAN</tradeName>
    <deviceName>TR Filling Block</deviceName>
    <manufacturerName>HumanTech Spine GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010596</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1501010003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:40:48.311Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250539935960</udiDi>
    <basicUdiDi>42505399192NK</basicUdiDi>
    <tradeName>SAMSON</tradeName>
    <deviceName>Torque Driver</deviceName>
    <manufacturerName>HumanTech Spine GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010596</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2000040231</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:40:47.494Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250539935441</udiDi>
    <basicUdiDi>42505399152N7</basicUdiDi>
    <tradeName>ADONIS</tradeName>
    <deviceName>AD Release bar</deviceName>
    <manufacturerName>HumanTech Spine GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010596</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1801010004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:40:46.796Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250539933843</udiDi>
    <basicUdiDi>42505399179NT</basicUdiDi>
    <tradeName>HERO</tradeName>
    <deviceName>HE Handle</deviceName>
    <manufacturerName>HumanTech Spine GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010596</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1101010011</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:40:29.835Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250539933805</udiDi>
    <basicUdiDi>42505399176NM</basicUdiDi>
    <tradeName>HERO</tradeName>
    <deviceName>HE Plate Bender</deviceName>
    <manufacturerName>HumanTech Spine GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010596</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1101010006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:40:29.063Z</lastUpdated>
  </row>
</eudamedExport>