<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>07290117771808</udiDi>
    <basicUdiDi>729011777OPTKTJK</basicUdiDi>
    <tradeName>OptiLight IPL 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>MDR 2017/745</legislation>
    <emdnCode>Z12011019</emdnCode>
    <emdnDescription>MULTI–PLATFORM LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KT-2011950Be</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:01:00.468Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290117771761</udiDi>
    <basicUdiDi>729011777OPTHPJ2</basicUdiDi>
    <tradeName>OPT 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>MDR 2017/745</legislation>
    <emdnCode>Z12011019</emdnCode>
    <emdnDescription>MULTI–PLATFORM LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA-20121450Be</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:00:59.674Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290117771747</udiDi>
    <basicUdiDi>729011777OPTTPK6</basicUdiDi>
    <tradeName>Opti-Tip™</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>MDR 2017/745</legislation>
    <emdnCode>Z12011019</emdnCode>
    <emdnDescription>MULTI–PLATFORM LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KT-00022901Be</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:00:55.662Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290117771723</udiDi>
    <basicUdiDi>729011777OPTN8</basicUdiDi>
    <tradeName>Digital 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>MDR 2017/745</legislation>
    <emdnCode>Z12011019</emdnCode>
    <emdnDescription>MULTI–PLATFORM LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GA-0005500DIG</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:00:54.876Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290117771662</udiDi>
    <basicUdiDi>729011777UPASCNLQ</basicUdiDi>
    <tradeName>DeepFX Microscanner</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>MDR 2017/745</legislation>
    <emdnCode>Z12011080</emdnCode>
    <emdnDescription>LASER SURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC-00013550Be</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:00:54.066Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290117771709</udiDi>
    <basicUdiDi>729011777UPAHPH5</basicUdiDi>
    <tradeName>UltraPulse Focused Incisional 0.2mm &amp; 1.0mm Handpiece Set</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>MDR 2017/745</legislation>
    <emdnCode>Z12011080</emdnCode>
    <emdnDescription>LASER SURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC-00013080Be</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:00:53.607Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290117771471</udiDi>
    <basicUdiDi>729011777APSCNCG</basicUdiDi>
    <tradeName>SurgiTouch™ Scanner</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>MDR 2017/745</legislation>
    <emdnCode>Z12011080</emdnCode>
    <emdnDescription>LASER SURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA-1023230Be , SPN-1028780Be</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:00:51.151Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290117771532</udiDi>
    <basicUdiDi>729011777APUGEG</basicUdiDi>
    <tradeName>AcuPulse™ Upgrade Kit 40 to 40AES-R</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>MDR 2017/745</legislation>
    <emdnCode>Z12011080</emdnCode>
    <emdnDescription>LASER SURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UG-0000370Be</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:00:49.275Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290117770795</udiDi>
    <basicUdiDi>729011777STRP4</basicUdiDi>
    <tradeName>FemTouch™ Standard Panoramic Disposable Tip</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 IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12011080</emdnCode>
    <emdnDescription>LASER SURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC-2005209Be</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:00:35.389Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290117770740</udiDi>
    <basicUdiDi>729011777FMADPTCU</basicUdiDi>
    <tradeName>FemTouch™ Adaptor 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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12011080</emdnCode>
    <emdnDescription>LASER SURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC-2009595Be</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:00:32.907Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290117770207</udiDi>
    <basicUdiDi>729011777RFXHPHH</basicUdiDi>
    <tradeName>ResurFXTM 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>MDR 2017/745</legislation>
    <emdnCode>Z12011019</emdnCode>
    <emdnDescription>MULTI–PLATFORM LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA-1146410Be , SPSA-1146410Be , RSP-1146410Be , SA-1146415 , SPSA-1146415</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:00:22.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290117770191</udiDi>
    <basicUdiDi>729011777UPKTJQ</basicUdiDi>
    <tradeName>Stellar M22™ ResurFX™ Module 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>MDR 2017/745</legislation>
    <emdnCode>Z12011019</emdnCode>
    <emdnDescription>MULTI–PLATFORM LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UG-2010701Be , UG-2010702</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:00:20.578Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290117770160</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>MDR 2017/745</legislation>
    <emdnCode>Z12011019</emdnCode>
    <emdnDescription>MULTI–PLATFORM LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA-1020220Be , AC-1020220Be , RSA-1020220Be , RAC-1020220Be</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:00:18.938Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290117770047</udiDi>
    <basicUdiDi>729011777UPAMY</basicUdiDi>
    <tradeName>UltraPulse® α</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>MDR 2017/745</legislation>
    <emdnCode>Z12011005</emdnCode>
    <emdnDescription>CARBON DIOXIDE SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GA-2000011 , GA-2000021</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:00:16.552Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290109222035</udiDi>
    <basicUdiDi>729010922AC21107M9</basicUdiDi>
    <tradeName>WatchPAT™ Central Plus Sensor</tradeName>
    <deviceName>Watch-PAT300</deviceName>
    <manufacturerName>Itamar Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000012046</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC3000100</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:00:07.743Z</lastUpdated>
  </row>
  <row>
    <udiDi>06980294872078</udiDi>
    <basicUdiDi>697885897ot001GM</basicUdiDi>
    <tradeName>06980294872078</tradeName>
    <deviceName>Operation Table</deviceName>
    <manufacturerName>HEFEI MT MEDICAL CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000008983</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12011202</emdnCode>
    <emdnDescription>OPERATING TABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06980294872078</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:00:03.739Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978858978519</udiDi>
    <basicUdiDi>697885897ExLightJJ</basicUdiDi>
    <tradeName>06978858978519</tradeName>
    <deviceName>Examination Light</deviceName>
    <manufacturerName>HEFEI MT MEDICAL CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000008983</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z129004</emdnCode>
    <emdnDescription>LIGHT SOURCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YDK</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:59:59.726Z</lastUpdated>
  </row>
  <row>
    <udiDi>05400606983830</udiDi>
    <basicUdiDi>8017990BKU6</basicUdiDi>
    <tradeName>Healtcare - Kinetic Muscle Sports tape</tradeName>
    <deviceName>BENDA ELASTICA ADESIVA KINETIC</deviceName>
    <manufacturerName>Eurosirel Spa</manufacturerName>
    <manufacturerSrn>IT-MF-000005982</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12069099</emdnCode>
    <emdnDescription>VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BK983830</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:59:31.057Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290109222837</udiDi>
    <basicUdiDi>729010922AC20003LM</basicUdiDi>
    <tradeName>WatchPAT™ Tamper Proof Bracelet</tradeName>
    <deviceName>Tamper-Proof Bracelet for WatchPAT</deviceName>
    <manufacturerName>Itamar Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000012046</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC2000300</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:56:13.048Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290109222424</udiDi>
    <basicUdiDi>729010922AC21508MX</basicUdiDi>
    <tradeName>WatchPAT™ONE</tradeName>
    <deviceName>WatchPAT ONE</deviceName>
    <manufacturerName>Itamar Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000012046</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC2110800</reference>
    <placedOnMarketCountry>Latvia</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:56:12.248Z</lastUpdated>
  </row>
</eudamedExport>