<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04049958004377</udiDi>
    <basicUdiDi>B-04049958004377</basicUdiDi>
    <tradeName>Dornier Medilas H140</tradeName>
    <deviceName>Dornier Medilas H140</deviceName>
    <manufacturerName>Dornier MedTech GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000009774</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011003</emdnCode>
    <emdnDescription>HOLMIUM SURGICAL LASER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>K2015300</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:26:20.424Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049958004360</udiDi>
    <basicUdiDi>B-04049958004360</basicUdiDi>
    <tradeName>04049958004360</tradeName>
    <deviceName>Dornier Solvo H35</deviceName>
    <manufacturerName>Dornier MedTech GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000009774</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011003</emdnCode>
    <emdnDescription>HOLMIUM SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K2014700</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:26:19.622Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049958004353</udiDi>
    <basicUdiDi>B-04049958004353</basicUdiDi>
    <tradeName>04049958004353</tradeName>
    <deviceName>Dornier Solvo H35</deviceName>
    <manufacturerName>Dornier MedTech GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000009774</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011003</emdnCode>
    <emdnDescription>HOLMIUM SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K2014600</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:26:18.824Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049958004315</udiDi>
    <basicUdiDi>B-04049958004315</basicUdiDi>
    <tradeName>04049958004315</tradeName>
    <deviceName>Dornier Solvo H30</deviceName>
    <manufacturerName>Dornier MedTech GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000009774</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011003</emdnCode>
    <emdnDescription>HOLMIUM SURGICAL LASER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>K2013000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:26:18.026Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049958004254</udiDi>
    <basicUdiDi>B-04049958004254</basicUdiDi>
    <tradeName>04049958004254</tradeName>
    <deviceName>Dornier Solvo H30</deviceName>
    <manufacturerName>Dornier MedTech GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000009774</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011003</emdnCode>
    <emdnDescription>HOLMIUM SURGICAL LASER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>K2012800</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:26:13.227Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049958004100</udiDi>
    <basicUdiDi>B-04049958004100</basicUdiDi>
    <tradeName>Dornier Medilas H140</tradeName>
    <deviceName>Dornier Medilas H140</deviceName>
    <manufacturerName>Dornier MedTech GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000009774</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011003</emdnCode>
    <emdnDescription>HOLMIUM SURGICAL LASER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>K2015000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:24:18.543Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049958004094</udiDi>
    <basicUdiDi>B-04049958004094</basicUdiDi>
    <tradeName>Dornier H140</tradeName>
    <deviceName>Dornier Medilas H140</deviceName>
    <manufacturerName>Dornier MedTech GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000009774</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011003</emdnCode>
    <emdnDescription>HOLMIUM SURGICAL LASER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>K2014800</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:24:16.966Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049958003707</udiDi>
    <basicUdiDi>B-04049958003707</basicUdiDi>
    <tradeName>Dornier Solvo H30</tradeName>
    <deviceName>Dornier Solvo H30</deviceName>
    <manufacturerName>Dornier MedTech GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000009774</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011003</emdnCode>
    <emdnDescription>HOLMIUM SURGICAL LASER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>K2014050</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:24:14.548Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049958002861</udiDi>
    <basicUdiDi>B-04049958002861</basicUdiDi>
    <tradeName>Dornier HRM</tradeName>
    <deviceName>Dornier Medilas H Uropulse</deviceName>
    <manufacturerName>Dornier MedTech GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000009774</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011003</emdnCode>
    <emdnDescription>HOLMIUM SURGICAL LASER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>K2013100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:24:12.945Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049958002625</udiDi>
    <basicUdiDi>B-04049958002625</basicUdiDi>
    <tradeName>Dornier HRM</tradeName>
    <deviceName>Dornier Medilas H UroPulse</deviceName>
    <manufacturerName>Dornier MedTech GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000009774</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011003</emdnCode>
    <emdnDescription>HOLMIUM SURGICAL LASER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>K2012900</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:24:12.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>00865325000186</udiDi>
    <basicUdiDi>B-00865325000186</basicUdiDi>
    <tradeName>MED-Fibers, Inc.</tradeName>
    <deviceName>MF-272/300-A</deviceName>
    <manufacturerName>MED-Fibers, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000039524</manufacturerSrn>
    <authorisedRepresentativeName>Total-Laser Solution GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>AT-AR-000021498</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011003</emdnCode>
    <emdnDescription>HOLMIUM SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MF-272/300-A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:49:42.343Z</lastUpdated>
  </row>
  <row>
    <udiDi>00865325000179</udiDi>
    <basicUdiDi>B-00865325000179</basicUdiDi>
    <tradeName>MED-Fibers, Inc.</tradeName>
    <deviceName>MF-200-SBT</deviceName>
    <manufacturerName>MED-Fibers, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000039524</manufacturerSrn>
    <authorisedRepresentativeName>Total-Laser Solution GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>AT-AR-000021498</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011003</emdnCode>
    <emdnDescription>HOLMIUM SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MF-200-SBT</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:49:41.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>00865325000193</udiDi>
    <basicUdiDi>B-00865325000193</basicUdiDi>
    <tradeName>MED-Fibers, Inc.</tradeName>
    <deviceName>MF-365/400-A</deviceName>
    <manufacturerName>MED-Fibers, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000039524</manufacturerSrn>
    <authorisedRepresentativeName>Total-Laser Solution GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>AT-AR-000021498</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011003</emdnCode>
    <emdnDescription>HOLMIUM SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MF-365/400-A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:49:40.030Z</lastUpdated>
  </row>
  <row>
    <udiDi>00865325000162</udiDi>
    <basicUdiDi>B-00865325000162</basicUdiDi>
    <tradeName>MED-Fibers, Inc.</tradeName>
    <deviceName>MF-200-SBT-BT</deviceName>
    <manufacturerName>MED-Fibers, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000039524</manufacturerSrn>
    <authorisedRepresentativeName>Total-Laser Solution GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>AT-AR-000021498</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011003</emdnCode>
    <emdnDescription>HOLMIUM SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MF-200-SBT-BT</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:49:25.445Z</lastUpdated>
  </row>
  <row>
    <udiDi>00865325000155</udiDi>
    <basicUdiDi>B-00865325000155</basicUdiDi>
    <tradeName>MED-Fibers, Inc.</tradeName>
    <deviceName>MF-1000/1100-HCBT</deviceName>
    <manufacturerName>MED-Fibers, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000039524</manufacturerSrn>
    <authorisedRepresentativeName>Total-Laser Solution GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>AT-AR-000021498</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011003</emdnCode>
    <emdnDescription>HOLMIUM SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MF-1000/1100-HCBT</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:49:21.439Z</lastUpdated>
  </row>
  <row>
    <udiDi>00865325000148</udiDi>
    <basicUdiDi>B-00865325000148</basicUdiDi>
    <tradeName>MED-Fibers, Inc.</tradeName>
    <deviceName>MF-550/600-HCBT</deviceName>
    <manufacturerName>MED-Fibers, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000039524</manufacturerSrn>
    <authorisedRepresentativeName>Total-Laser Solution GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>AT-AR-000021498</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011003</emdnCode>
    <emdnDescription>HOLMIUM SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MF-550/600-HCBT</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:49:20.637Z</lastUpdated>
  </row>
  <row>
    <udiDi>00865325000131</udiDi>
    <basicUdiDi>B-00865325000131</basicUdiDi>
    <tradeName>MED-Fibers, Inc.</tradeName>
    <deviceName>MF-365/400-SBT</deviceName>
    <manufacturerName>MED-Fibers, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000039524</manufacturerSrn>
    <authorisedRepresentativeName>Total-Laser Solution GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>AT-AR-000021498</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011003</emdnCode>
    <emdnDescription>HOLMIUM SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MF-365/400-SBT</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:49:19.836Z</lastUpdated>
  </row>
  <row>
    <udiDi>00865325000124</udiDi>
    <basicUdiDi>B-00865325000124</basicUdiDi>
    <tradeName>MED-Fibers, Inc.</tradeName>
    <deviceName>MF-272/300-SBT</deviceName>
    <manufacturerName>MED-Fibers, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000039524</manufacturerSrn>
    <authorisedRepresentativeName>Total-Laser Solution GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>AT-AR-000021498</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011003</emdnCode>
    <emdnDescription>HOLMIUM SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MF-272/300-SBT</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:49:19.033Z</lastUpdated>
  </row>
  <row>
    <udiDi>00865325000117</udiDi>
    <basicUdiDi>B-00865325000117</basicUdiDi>
    <tradeName>MED-Fibers, Inc.</tradeName>
    <deviceName>MF-400/440-RM-TB</deviceName>
    <manufacturerName>MED-Fibers, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000039524</manufacturerSrn>
    <authorisedRepresentativeName>Total-Laser Solution GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>AT-AR-000021498</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011003</emdnCode>
    <emdnDescription>HOLMIUM SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MF-400/440-RM-TB</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:49:15.034Z</lastUpdated>
  </row>
  <row>
    <udiDi>00865325000100</udiDi>
    <basicUdiDi>B-00865325000100</basicUdiDi>
    <tradeName>MED-Fibers, Inc.</tradeName>
    <deviceName>MF-600/630-RM</deviceName>
    <manufacturerName>MED-Fibers, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000039524</manufacturerSrn>
    <authorisedRepresentativeName>Total-Laser Solution GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>AT-AR-000021498</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011003</emdnCode>
    <emdnDescription>HOLMIUM SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MF-600/630-RM</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:49:14.344Z</lastUpdated>
  </row>
</eudamedExport>