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<eudamedExport entity="devices">
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    <udiDi>08800020107510</udiDi>
    <basicUdiDi>B-08800020107510</basicUdiDi>
    <tradeName>I-25 TIP</tradeName>
    <deviceName>I-25 TIP</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>K020380</emdnCode>
    <emdnDescription>DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I-25</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:06:00.781Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800020107503</udiDi>
    <basicUdiDi>B-08800020107503</basicUdiDi>
    <tradeName>I-49 TIP</tradeName>
    <deviceName>I-49 TIP</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>K020380</emdnCode>
    <emdnDescription>DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I-49</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:05:59.986Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800020107497</udiDi>
    <basicUdiDi>B-08800020107497</basicUdiDi>
    <tradeName>S-16 TIP</tradeName>
    <deviceName>S-16 TIP</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>K020380</emdnCode>
    <emdnDescription>DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S-16</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:05:55.982Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800020107480</udiDi>
    <basicUdiDi>B-08800020107480</basicUdiDi>
    <tradeName>S-25 TIP</tradeName>
    <deviceName>S-25 TIP</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>K020380</emdnCode>
    <emdnDescription>DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S-25</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:05:55.176Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800020107473</udiDi>
    <basicUdiDi>B-08800020107473</basicUdiDi>
    <tradeName>S-49 Electrode</tradeName>
    <deviceName>S-49 TIP</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>K020380</emdnCode>
    <emdnDescription>DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S-49</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:05:54.377Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800020100481</udiDi>
    <basicUdiDi>B-08800020100481</basicUdiDi>
    <tradeName>CP-21 TIP</tradeName>
    <deviceName>CP-21 TIP</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>K020380</emdnCode>
    <emdnDescription>DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP-21</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:05:48.883Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0858584002MWAS9GFV</udiDi>
    <basicUdiDi>B-0858584002MWAS9GFV</basicUdiDi>
    <tradeName>Avecure Microwave Ablation System</tradeName>
    <deviceName>Avecure Microwave Ablation System</deviceName>
    <manufacturerName>Medwaves, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000053179</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K02030199</emdnCode>
    <emdnDescription>RADIOFREQUENCY SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MWAS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:13:32.318Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0858584002MECO/SECO92QG</udiDi>
    <basicUdiDi>B-0858584002MECO/SECO92QG</basicUdiDi>
    <tradeName>AveCure Extension Cable Set</tradeName>
    <deviceName>AveCure Extension Cable Set</deviceName>
    <manufacturerName>Medwaves, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000053179</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K02030199</emdnCode>
    <emdnDescription>RADIOFREQUENCY SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MECO/SECO</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:13:31.493Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-085858400216900110NUT2</udiDi>
    <basicUdiDi>B-085858400216900110NUT2</basicUdiDi>
    <tradeName>AveCure 16G Flexible Probe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medwaves, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000053179</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K02030199</emdnCode>
    <emdnDescription>RADIOFREQUENCY SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16-90-01-10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:13:29.884Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0858584002161230115UKWP</udiDi>
    <basicUdiDi>B-0858584002161230115UKWP</basicUdiDi>
    <tradeName>AveCure 16G Flexible Probe</tradeName>
    <deviceName>AveCure 16G Flexible Probe</deviceName>
    <manufacturerName>Medwaves, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000053179</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K02030199</emdnCode>
    <emdnDescription>RADIOFREQUENCY SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16-123-01-15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:13:28.303Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-08585840021610LH15YH9W</udiDi>
    <basicUdiDi>B-08585840021610LH15YH9W</basicUdiDi>
    <tradeName>AveCure 16G Small Antenna Probe</tradeName>
    <deviceName>AveCure 16G Small Antenna Probe</deviceName>
    <manufacturerName>Medwaves, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000053179</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K02030199</emdnCode>
    <emdnDescription>RADIOFREQUENCY SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16-10-LH-15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:13:27.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>08058983740620</udiDi>
    <basicUdiDi>B-08058983740620</basicUdiDi>
    <tradeName>RF AMICA-PROBE</tradeName>
    <deviceName>RF AMICA-PROBE</deviceName>
    <manufacturerName>H.S. Hospital Service S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000026770</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K02030101</emdnCode>
    <emdnDescription>RADIOFREQUENCY SURGERY ELECTRODES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RF17100E05V1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T19:28:36.788Z</lastUpdated>
  </row>
  <row>
    <udiDi>08058341211304</udiDi>
    <basicUdiDi>B-08058341211304</basicUdiDi>
    <tradeName>RF BLUNT Straight Cannula</tradeName>
    <deviceName>RF BLUNT Straight Cannula</deviceName>
    <manufacturerName>M.D.L. S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000011599</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K02030106</emdnCode>
    <emdnDescription>RADIOFREQUENCY SURGERY CANNULAS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RF0M22100R10A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:59:25.717Z</lastUpdated>
  </row>
  <row>
    <udiDi>08058341210420</udiDi>
    <basicUdiDi>B-08058341210420</basicUdiDi>
    <tradeName>RF BLUNT Straight Cannula</tradeName>
    <deviceName>RF BLUNT Straight Cannula</deviceName>
    <manufacturerName>M.D.L. S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000011599</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K02030106</emdnCode>
    <emdnDescription>RADIOFREQUENCY SURGERY CANNULAS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RF0M20150R10A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:59:13.708Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056479540907</udiDi>
    <basicUdiDi>B-08056479540907</basicUdiDi>
    <tradeName>08056479540907</tradeName>
    <deviceName>VOYAGER LINEAR</deviceName>
    <manufacturerName>ALFAMED SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000033580</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K020399</emdnCode>
    <emdnDescription>DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VAL2040-BC</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:28:14.370Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056479540235</udiDi>
    <basicUdiDi>B-08056479540235</basicUdiDi>
    <tradeName>08056479540235</tradeName>
    <deviceName>VOYAGER VAR</deviceName>
    <manufacturerName>ALFAMED SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000033580</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K020399</emdnCode>
    <emdnDescription>DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VAR5030-MC</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:28:13.562Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056479540181</udiDi>
    <basicUdiDi>B-08056479540181</basicUdiDi>
    <tradeName>08056479540181</tradeName>
    <deviceName>VOYAGER LINEAR</deviceName>
    <manufacturerName>ALFAMED SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000033580</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K020399</emdnCode>
    <emdnDescription>DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VAL4040-MC</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:28:03.178Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056479540174</udiDi>
    <basicUdiDi>B-08056479540174</basicUdiDi>
    <tradeName>08056479540174</tradeName>
    <deviceName>VOYAGER LINEAR</deviceName>
    <manufacturerName>ALFAMED SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000033580</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K020399</emdnCode>
    <emdnDescription>DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VAL4040-BC</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:28:02.390Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056479540143</udiDi>
    <basicUdiDi>B-08056479540143</basicUdiDi>
    <tradeName>08056479540143</tradeName>
    <deviceName>VOYAGER L</deviceName>
    <manufacturerName>ALFAMED SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000033580</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K020399</emdnCode>
    <emdnDescription>DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VA3540-L</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:27:56.762Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056479540136</udiDi>
    <basicUdiDi>B-08056479540136</basicUdiDi>
    <tradeName>08056479540136</tradeName>
    <deviceName>VOYAGER</deviceName>
    <manufacturerName>ALFAMED SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000033580</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K020399</emdnCode>
    <emdnDescription>DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VA3540-BT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:27:55.970Z</lastUpdated>
  </row>
</eudamedExport>