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<eudamedExport entity="devices">
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    <udiDi>08809578390269</udiDi>
    <basicUdiDi>B-08809578390269</basicUdiDi>
    <tradeName>BU:TERA</tradeName>
    <deviceName>High Intensity Focused Ultrasound</deviceName>
    <manufacturerName>IDS LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000018259</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120610</emdnCode>
    <emdnDescription>ULTRASOUND THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IDS-UM-0821</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:15:17.368Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809495930005</udiDi>
    <basicUdiDi>B-08809495930005</basicUdiDi>
    <tradeName>CWM-940</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chungwoo Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000017583</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120610</emdnCode>
    <emdnDescription>ULTRASOUND THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[CW-940(IFU)] CWM-940 User manual (Rev.6)</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:13:26.745Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800042100223</udiDi>
    <basicUdiDi>B-08800042100223</basicUdiDi>
    <tradeName>HI-REX</tradeName>
    <deviceName>High Intensity Focused Ultrasound</deviceName>
    <manufacturerName>AMI INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000017522</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120610</emdnCode>
    <emdnDescription>ULTRASOUND THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMI-CL-0841</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:26:14.250Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800042100216</udiDi>
    <basicUdiDi>B-08800042100216</basicUdiDi>
    <tradeName>VIOLA</tradeName>
    <deviceName>High Intensity Focused Ultrasound</deviceName>
    <manufacturerName>AMI INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000017522</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120610</emdnCode>
    <emdnDescription>ULTRASOUND THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMI-CL-0811</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:26:11.853Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800022301374</udiDi>
    <basicUdiDi>B-08800022301374</basicUdiDi>
    <tradeName>Tightan Pro</tradeName>
    <deviceName>Tightan Pro</deviceName>
    <manufacturerName>WON TECH Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000016169</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120610</emdnCode>
    <emdnDescription>ULTRASOUND THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Focused Ultrasound Stimulator System</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:42:48.400Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800020109095</udiDi>
    <basicUdiDi>B-08800020109095</basicUdiDi>
    <tradeName>N13 Cartridge</tradeName>
    <deviceName>N13 Cartridge</deviceName>
    <manufacturerName>Jeisys Medical Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000008513</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120610</emdnCode>
    <emdnDescription>ULTRASOUND THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N13 Cartridge</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:06:51.448Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800020109088</udiDi>
    <basicUdiDi>B-08800020109088</basicUdiDi>
    <tradeName>L13 Cartridge</tradeName>
    <deviceName>L13 Cartridge</deviceName>
    <manufacturerName>Jeisys Medical Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000008513</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120610</emdnCode>
    <emdnDescription>ULTRASOUND THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L13 Cartridge</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:06:49.850Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800020109064</udiDi>
    <basicUdiDi>B-08800020109064</basicUdiDi>
    <tradeName>L8 Cartridge</tradeName>
    <deviceName>L8 Cartridge</deviceName>
    <manufacturerName>Jeisys Medical Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000008513</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120610</emdnCode>
    <emdnDescription>ULTRASOUND THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LIPOcel_L8 Cartridge</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:06:49.051Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800020109057</udiDi>
    <basicUdiDi>B-08800020109057</basicUdiDi>
    <tradeName>L4.5 Cartridge</tradeName>
    <deviceName>L4.5 Cartridge</deviceName>
    <manufacturerName>Jeisys Medical Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000008513</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120610</emdnCode>
    <emdnDescription>ULTRASOUND THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L4.5 Cartridge</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:06:47.463Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800020109071</udiDi>
    <basicUdiDi>B-08800020109071</basicUdiDi>
    <tradeName>L11 Cartridge</tradeName>
    <deviceName>L11 Cartridge</deviceName>
    <manufacturerName>Jeisys Medical Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000008513</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120610</emdnCode>
    <emdnDescription>ULTRASOUND THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L11 Cartridge</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:06:33.681Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800020101877</udiDi>
    <basicUdiDi>B-08800020101877</basicUdiDi>
    <tradeName>Sonotrip V20</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jeisys Medical Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000008513</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120610</emdnCode>
    <emdnDescription>ULTRASOUND THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>17</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:05:53.577Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800017500089</udiDi>
    <basicUdiDi>B-08800017500089</basicUdiDi>
    <tradeName>High Intensity Focused Ultrasonic Equipment</tradeName>
    <deviceName>High Intensity Focused Ultrasound System</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120610</emdnCode>
    <emdnDescription>ULTRASOUND THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DJMD0001</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:59:35.853Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800016900446</udiDi>
    <basicUdiDi>B-08800016900446</basicUdiDi>
    <tradeName>Ulfit</tradeName>
    <deviceName>Focused Ultrasound Therapeutic Equipment</deviceName>
    <manufacturerName>CLASSYS</manufacturerName>
    <manufacturerSrn>KR-MF-000010116</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120610</emdnCode>
    <emdnDescription>ULTRASOUND THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UF1-M200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:57:36.021Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800016900026</udiDi>
    <basicUdiDi>B-08800016900026</basicUdiDi>
    <tradeName>ULTRAFORMER III</tradeName>
    <deviceName>Focused Ultrasound Therapeutic Equipment</deviceName>
    <manufacturerName>CLASSYS</manufacturerName>
    <manufacturerSrn>KR-MF-000010116</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120610</emdnCode>
    <emdnDescription>ULTRASOUND THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UF3-M300</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:57:20.764Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057949170563</udiDi>
    <basicUdiDi>B-08057949170563</basicUdiDi>
    <tradeName>FISIOSONIC</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FISIOLINE SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000027924</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120610</emdnCode>
    <emdnDescription>ULTRASOUND THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FISIOSONICR3</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:38:54.412Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056999870164</udiDi>
    <basicUdiDi>B-08056999870164</basicUdiDi>
    <tradeName>qmd ultrasound cryo thermal</tradeName>
    <deviceName>ultrasound cryo thermal</deviceName>
    <manufacturerName>Hakomed Italia Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000031004</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120610</emdnCode>
    <emdnDescription>ULTRASOUND THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Q-0305</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:32:00.384Z</lastUpdated>
  </row>
  <row>
    <udiDi>08055719580116</udiDi>
    <basicUdiDi>B-08055719580116</basicUdiDi>
    <tradeName>MIXING2</tradeName>
    <deviceName>MIXING2</deviceName>
    <manufacturerName>Project Blue Generation s.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000027914</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120610</emdnCode>
    <emdnDescription>ULTRASOUND THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3M00</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:00:31.929Z</lastUpdated>
  </row>
  <row>
    <udiDi>08055719580048</udiDi>
    <basicUdiDi>B-08055719580048</basicUdiDi>
    <tradeName>US13</tradeName>
    <deviceName>US13</deviceName>
    <manufacturerName>Project Blue Generation s.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000027914</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120610</emdnCode>
    <emdnDescription>ULTRASOUND THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILINE.US13</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:00:25.744Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290018152003</udiDi>
    <basicUdiDi>B-07290018152003</basicUdiDi>
    <tradeName>Sofwave</tradeName>
    <deviceName>Sofwave</deviceName>
    <manufacturerName>Sofwave Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000019200</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120610</emdnCode>
    <emdnDescription>ULTRASOUND THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG00001INT</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:10:24.169Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975039130094</udiDi>
    <basicUdiDi>B-06975039130094</basicUdiDi>
    <tradeName>High Intensity Focused Ultrasound System</tradeName>
    <deviceName>High Intensity Focused Ultrasound System</deviceName>
    <manufacturerName>Shenzhen PRO HITU Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021578</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120610</emdnCode>
    <emdnDescription>ULTRASOUND THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MDD2022MA3375</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:29:58.706Z</lastUpdated>
  </row>
</eudamedExport>