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<eudamedExport entity="devices">
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    <udiDi>08800042100254</udiDi>
    <basicUdiDi>B-08800042100254</basicUdiDi>
    <tradeName>REX-CO</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>AMI-CL-0421</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:26:19.062Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800042100230</udiDi>
    <basicUdiDi>B-08800042100230</basicUdiDi>
    <tradeName>DX300</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>AMI-CL-0541</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:26:16.656Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800042100162</udiDi>
    <basicUdiDi>B-08800042100162</basicUdiDi>
    <tradeName>DI-REX</tradeName>
    <deviceName>Diode Surgical 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>AMI-CL-0221</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:26:03.857Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800042100155</udiDi>
    <basicUdiDi>B-08800042100155</basicUdiDi>
    <tradeName>BX300</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>AMI-CL-0531</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:26:03.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800042100100</udiDi>
    <basicUdiDi>B-08800042100100</basicUdiDi>
    <tradeName>NEOXEL</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>AMI-CL-0511</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:25:56.648Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800042100063</udiDi>
    <basicUdiDi>B-08800042100063</basicUdiDi>
    <tradeName>DERMAXEL</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>AMI-CL-0411</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:25:50.256Z</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>08800017500140</udiDi>
    <basicUdiDi>B-08800017500140</basicUdiDi>
    <tradeName>Ultra pulse CO2 fractional laser</tradeName>
    <deviceName>Ultra pulse CO2 frcational laser</deviceName>
    <manufacturerName>DAEJU MEDITECH ENGINEERING CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000020683</manufacturerSrn>
    <authorisedRepresentativeName>Javitech Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000045915</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011005</emdnCode>
    <emdnDescription>CARBON DIOXIDE SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DJMD0003</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:59:37.479Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800016903959</udiDi>
    <basicUdiDi>B-08800016903959</basicUdiDi>
    <tradeName>FRAXIS</tradeName>
    <deviceName>CO2 laser system</deviceName>
    <manufacturerName>CLASSYS</manufacturerName>
    <manufacturerSrn>KR-MF-000010116</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011005</emdnCode>
    <emdnDescription>CARBON DIOXIDE SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FRAXIS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:57:53.637Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800016903621</udiDi>
    <basicUdiDi>B-08800016903621</basicUdiDi>
    <tradeName>FRAXIS DUO</tradeName>
    <deviceName>CO2 laser system and High Frequency Surgical System with sterile micro needle electrodes</deviceName>
    <manufacturerName>CLASSYS</manufacturerName>
    <manufacturerSrn>KR-MF-000010116</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011005</emdnCode>
    <emdnDescription>CARBON DIOXIDE SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FRAXIS DUO</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:57:49.638Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973494938026</udiDi>
    <basicUdiDi>B-06973494938026</basicUdiDi>
    <tradeName>GLOBALIPL</tradeName>
    <deviceName>CO2 Fractional Laser Equipment</deviceName>
    <manufacturerName>Beijing Globalipl Development Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010924</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011005</emdnCode>
    <emdnDescription>CARBON DIOXIDE SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>US800</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:19:16.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971513122159</udiDi>
    <basicUdiDi>B-06971513122159</basicUdiDi>
    <tradeName>MED-870+</tradeName>
    <deviceName>Medical Fractional CO2 Laser Therapy Systems</deviceName>
    <manufacturerName>Beijing KES Biology Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002099</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011005</emdnCode>
    <emdnDescription>CARBON DIOXIDE SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CO2 MED-870+</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:59:02.226Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841494100513</udiDi>
    <basicUdiDi>B-00841494100513</basicUdiDi>
    <tradeName>Affirm 14mm Tip</tradeName>
    <deviceName>Affirm 14mm Tip</deviceName>
    <manufacturerName>Cynosure LLC</manufacturerName>
    <manufacturerSrn>US-MF-000010200</manufacturerSrn>
    <authorisedRepresentativeName>Cynosure B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000009566</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011005</emdnCode>
    <emdnDescription>CARBON DIOXIDE SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100-7004-814</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:11:58.380Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841494100506</udiDi>
    <basicUdiDi>B-00841494100506</basicUdiDi>
    <tradeName>Affirm 10mm Tip</tradeName>
    <deviceName>Affirm 10mm Tip</deviceName>
    <manufacturerName>Cynosure LLC</manufacturerName>
    <manufacturerSrn>US-MF-000010200</manufacturerSrn>
    <authorisedRepresentativeName>Cynosure B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000009566</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011005</emdnCode>
    <emdnDescription>CARBON DIOXIDE SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100-7004-910</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:11:54.376Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809447657363</udiDi>
    <basicUdiDi>88002918210409BJ3</basicUdiDi>
    <tradeName>Laser System main body (Including Handpiece)</tradeName>
    <deviceName>Surgical CO2 Laser (RF Type)</deviceName>
    <manufacturerName>Cynosure Lutronic Technology Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000047499</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12011005</emdnCode>
    <emdnDescription>CARBON DIOXIDE SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>eCO2 DENTA</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:39:48.038Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800291821153</udiDi>
    <basicUdiDi>88002918210409AHZ</basicUdiDi>
    <tradeName>Laser System main body (Including Handpiece)</tradeName>
    <deviceName>Surgical CO2 Laser (RF Type)</deviceName>
    <manufacturerName>Cynosure Lutronic Technology Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000047499</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12011005</emdnCode>
    <emdnDescription>CARBON DIOXIDE SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>eCO2 3D</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:36:42.158Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435259608226</udiDi>
    <basicUdiDi>84352596CDLZH</basicUdiDi>
    <tradeName>Silklase</tradeName>
    <deviceName>CarbonDioxLaser</deviceName>
    <manufacturerName>INTERmedic Arfran s.a.</manufacturerName>
    <manufacturerSrn>ES-MF-000038662</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12011005</emdnCode>
    <emdnDescription>CARBON DIOXIDE SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>31063</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:46:01.178Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056477090008</udiDi>
    <basicUdiDi>805647709SLIMEVO47</basicUdiDi>
    <tradeName>SLIM EVOLUTION</tradeName>
    <deviceName>SLIM EVOLUTION</deviceName>
    <manufacturerName>Lasering s.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000020505</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12011005</emdnCode>
    <emdnDescription>CARBON DIOXIDE SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AT0231</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T08:16:24.656Z</lastUpdated>
  </row>
  <row>
    <udiDi>08034108513089</udiDi>
    <basicUdiDi>803410851M133XXR5</basicUdiDi>
    <tradeName>HEMERA</tradeName>
    <deviceName>HEMERA/HELIX</deviceName>
    <manufacturerName>DEKA M.E.L.A. SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000007389</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12011005</emdnCode>
    <emdnDescription>CARBON DIOXIDE SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M133B1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:26:06.717Z</lastUpdated>
  </row>
  <row>
    <udiDi>08034108512693</udiDi>
    <basicUdiDi>803410851M079XXSL</basicUdiDi>
    <tradeName>SmartXide PRO</tradeName>
    <deviceName>SMARTXIDE family</deviceName>
    <manufacturerName>DEKA M.E.L.A. SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000007389</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12011005</emdnCode>
    <emdnDescription>CARBON DIOXIDE SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M079BH1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:26:01.904Z</lastUpdated>
  </row>
</eudamedExport>