<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08800042100056</udiDi>
    <basicUdiDi>B-08800042100056</basicUdiDi>
    <tradeName>ALLUX Nd:YAG</tradeName>
    <deviceName>Long Pulsed Nd:YAG Laser</deviceName>
    <manufacturerName>AMI INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000017522</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011012</emdnCode>
    <emdnDescription>DYE/ALEXANDRITE SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMI-CL-0613</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:25:49.468Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800042100049</udiDi>
    <basicUdiDi>B-08800042100049</basicUdiDi>
    <tradeName>ALLUX ALEX</tradeName>
    <deviceName>Alexandrite Laser</deviceName>
    <manufacturerName>AMI INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000017522</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011012</emdnCode>
    <emdnDescription>DYE/ALEXANDRITE SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMI-CL-0612</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:25:47.030Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800042100032</udiDi>
    <basicUdiDi>B-08800042100032</basicUdiDi>
    <tradeName>ALLUX DUAL</tradeName>
    <deviceName>Alexandrite &amp; Long Pulsed Nd:YAG Laser</deviceName>
    <manufacturerName>AMI INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000017522</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011012</emdnCode>
    <emdnDescription>DYE/ALEXANDRITE SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMI-CL-0611</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:25:44.642Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800042100018</udiDi>
    <basicUdiDi>B-08800042100018</basicUdiDi>
    <tradeName>BIOXEL</tradeName>
    <deviceName>Fractional CO2 Laser</deviceName>
    <manufacturerName>AMI INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000017522</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011005</emdnCode>
    <emdnDescription>CARBON DIOXIDE SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BIOXEL</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:25:43.042Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800042100001</udiDi>
    <basicUdiDi>B-08800042100001</basicUdiDi>
    <tradeName>Q-MASTER</tradeName>
    <deviceName>Q-Switched Nd:YAG Laser</deviceName>
    <manufacturerName>AMI INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000017522</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011017</emdnCode>
    <emdnDescription>NEODYMIUM SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMI-CL-0321</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:25:42.260Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800035501754</udiDi>
    <basicUdiDi>B-08800035501754</basicUdiDi>
    <tradeName>08800035501754</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Laseroptek</manufacturerName>
    <manufacturerSrn>KR-MF-000018426</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011017</emdnCode>
    <emdnDescription>NEODYMIUM SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HELIOS 785 Pico</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T20:20:50.195Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800035501105</udiDi>
    <basicUdiDi>B-08800035501105</basicUdiDi>
    <tradeName>08800035501105</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Laseroptek</manufacturerName>
    <manufacturerSrn>KR-MF-000018426</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011017</emdnCode>
    <emdnDescription>NEODYMIUM SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PicoLO PREMIUM</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-09T20:20:49.377Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800035501099</udiDi>
    <basicUdiDi>B-08800035501099</basicUdiDi>
    <tradeName>08800035501099</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Laseroptek</manufacturerName>
    <manufacturerSrn>KR-MF-000018426</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011017</emdnCode>
    <emdnDescription>NEODYMIUM SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PicoLO</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-09T20:20:48.559Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800035501051</udiDi>
    <basicUdiDi>B-08800035501051</basicUdiDi>
    <tradeName>08800035501051</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Laseroptek</manufacturerName>
    <manufacturerSrn>KR-MF-000018426</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011014</emdnCode>
    <emdnDescription>ERBIUM SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LOTUS III</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-09T20:20:47.763Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800035501044</udiDi>
    <basicUdiDi>B-08800035501044</basicUdiDi>
    <tradeName>08800035501044</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Laseroptek</manufacturerName>
    <manufacturerSrn>KR-MF-000018426</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011006</emdnCode>
    <emdnDescription>DIODE–PUMPED SOLID–STATE (DPSS) SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PALLAS</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-09T20:20:43.774Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800035501020</udiDi>
    <basicUdiDi>B-08800035501020</basicUdiDi>
    <tradeName>08800035501020</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Laseroptek</manufacturerName>
    <manufacturerSrn>KR-MF-000018426</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011017</emdnCode>
    <emdnDescription>NEODYMIUM SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HELIOS III</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-09T20:20:42.985Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290117771815</udiDi>
    <basicUdiDi>729011777OPTN8</basicUdiDi>
    <tradeName>OptiLight System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lumenis Be LTD</manufacturerName>
    <manufacturerSrn>IL-MF-000022063</manufacturerSrn>
    <authorisedRepresentativeName>Lumenis (Germany) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007699</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011019</emdnCode>
    <emdnDescription>MULTI–PLATFORM LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GA-0005500Be</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T20:01:09.336Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290117772768</udiDi>
    <basicUdiDi>729011777QSWHPKU</basicUdiDi>
    <tradeName>Stellar M22™ Q-Switched Nd:YAG Upgrade Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lumenis Be LTD</manufacturerName>
    <manufacturerSrn>IL-MF-000022063</manufacturerSrn>
    <authorisedRepresentativeName>Lumenis (Germany) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007699</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011019</emdnCode>
    <emdnDescription>MULTI–PLATFORM LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UGAC-20109600</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T20:01:09.097Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290117771778</udiDi>
    <basicUdiDi>729011777OPTHPJ2</basicUdiDi>
    <tradeName>OPT Module Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lumenis Be LTD</manufacturerName>
    <manufacturerSrn>IL-MF-000022063</manufacturerSrn>
    <authorisedRepresentativeName>Lumenis (Germany) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007699</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011019</emdnCode>
    <emdnDescription>MULTI–PLATFORM LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KT-2012586Be</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T20:01:09.025Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290117771785</udiDi>
    <basicUdiDi>729011777OPTHPJ2</basicUdiDi>
    <tradeName>OptiLight IPL Handpiece</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lumenis Be LTD</manufacturerName>
    <manufacturerSrn>IL-MF-000022063</manufacturerSrn>
    <authorisedRepresentativeName>Lumenis (Germany) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007699</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011019</emdnCode>
    <emdnDescription>MULTI–PLATFORM LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC-2011950-OPTBe</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T20:01:08.981Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290117771914</udiDi>
    <basicUdiDi>729011777OPTHPJ2</basicUdiDi>
    <tradeName>OptiLight IPL Handpiece</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lumenis Be LTD</manufacturerName>
    <manufacturerSrn>IL-MF-000022063</manufacturerSrn>
    <authorisedRepresentativeName>Lumenis (Germany) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007699</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011019</emdnCode>
    <emdnDescription>MULTI–PLATFORM LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC-20106870-OPTBe</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T20:01:08.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290117772751</udiDi>
    <basicUdiDi>729011777YAGHPG6</basicUdiDi>
    <tradeName>Stellar M22™ Multi-Spot™ Nd:YAG  Upgrade kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lumenis Be LTD</manufacturerName>
    <manufacturerSrn>IL-MF-000022063</manufacturerSrn>
    <authorisedRepresentativeName>Lumenis (Germany) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007699</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011019</emdnCode>
    <emdnDescription>MULTI–PLATFORM LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UGAC-20109590</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T20:01:08.272Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290117772737</udiDi>
    <basicUdiDi>729011777YAGHPG6</basicUdiDi>
    <tradeName>Multi-SpotTM  Nd:YAG Head</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lumenis Be LTD</manufacturerName>
    <manufacturerSrn>IL-MF-000022063</manufacturerSrn>
    <authorisedRepresentativeName>Lumenis (Germany) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007699</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011019</emdnCode>
    <emdnDescription>MULTI–PLATFORM LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC-10202200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T20:01:08.236Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290117771907</udiDi>
    <basicUdiDi>729011777OPTKTJK</basicUdiDi>
    <tradeName>IPL Upgrade Kit for OptiLight</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lumenis Be LTD</manufacturerName>
    <manufacturerSrn>IL-MF-000022063</manufacturerSrn>
    <authorisedRepresentativeName>Lumenis (Germany) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007699</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011019</emdnCode>
    <emdnDescription>MULTI–PLATFORM LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UG-00024720Be</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T20:01:06.910Z</lastUpdated>
  </row>
  <row>
    <udiDi>03830054230125</udiDi>
    <basicUdiDi>3830054230005S9</basicUdiDi>
    <tradeName>XS Dynamis</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FOTONA, proizvodnja optoelektronskih naprav d.o.o.</manufacturerName>
    <manufacturerSrn>SI-MF-000000126</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011019</emdnCode>
    <emdnDescription>MULTI–PLATFORM LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M002-2A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T20:01:06.043Z</lastUpdated>
  </row>
</eudamedExport>