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<eudamedExport entity="devices">
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    <udiDi>00193493001477</udiDi>
    <basicUdiDi>0193493CSER00063QU</basicUdiDi>
    <tradeName>00193493001477</tradeName>
    <deviceName>COOLIEF* SINERGY* Epsilon* Ruler</deviceName>
    <manufacturerName>Avanos Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016181</manufacturerSrn>
    <authorisedRepresentativeName>Avanos Medical Belgium BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000002191</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K020380</emdnCode>
    <emdnDescription>DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>120005516</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:03:25.168Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813250016727</udiDi>
    <basicUdiDi>01915060000000000000179NC</basicUdiDi>
    <tradeName>Palisade™</tradeName>
    <deviceName>Palisade Guide Block</deviceName>
    <manufacturerName>Boston Scientific Neuromodulation Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004703</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K020380</emdnCode>
    <emdnDescription>DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PG-1020</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:55:22.884Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813250014570</udiDi>
    <basicUdiDi>01915060000000000000178NA</basicUdiDi>
    <tradeName>00813250014570</tradeName>
    <deviceName>Depth Stop</deviceName>
    <manufacturerName>Boston Scientific Neuromodulation Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004703</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K020380</emdnCode>
    <emdnDescription>DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DS-11-D</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:55:22.090Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813250011791</udiDi>
    <basicUdiDi>01915060000000000000081MS</basicUdiDi>
    <tradeName>00813250011791</tradeName>
    <deviceName>Test Plug</deviceName>
    <manufacturerName>Boston Scientific Neuromodulation Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004703</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K020380</emdnCode>
    <emdnDescription>DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RFG-TP</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:55:17.200Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813250011746</udiDi>
    <basicUdiDi>01915060000000000000080MQ</basicUdiDi>
    <tradeName>00813250011746</tradeName>
    <deviceName>Footswitch</deviceName>
    <manufacturerName>Boston Scientific Neuromodulation Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004703</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K020380</emdnCode>
    <emdnDescription>DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FS-1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:55:16.460Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813250011470</udiDi>
    <basicUdiDi>01915060000000000000082MU</basicUdiDi>
    <tradeName>CSK™</tradeName>
    <deviceName>Sterilizable Case</deviceName>
    <manufacturerName>Boston Scientific Neuromodulation Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004703</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K020380</emdnCode>
    <emdnDescription>DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CSK-CASE</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:55:15.754Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800020107619</udiDi>
    <basicUdiDi>B-08800020107619</basicUdiDi>
    <tradeName>DIAMOND TIP</tradeName>
    <deviceName>DIAMOND 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>DIAMOND</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:06:16.895Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800020107602</udiDi>
    <basicUdiDi>B-08800020107602</basicUdiDi>
    <tradeName>DDR TIP</tradeName>
    <deviceName>DDR 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>DDR</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:06:15.199Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800020107596</udiDi>
    <basicUdiDi>B-08800020107596</basicUdiDi>
    <tradeName>SFA TIP</tradeName>
    <deviceName>SFA 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>SFA</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:06:14.393Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800020107589</udiDi>
    <basicUdiDi>B-08800020107589</basicUdiDi>
    <tradeName>P1-08 TIP</tradeName>
    <deviceName>P1-08 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>P1-08</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:06:13.600Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800020107572</udiDi>
    <basicUdiDi>B-08800020107572</basicUdiDi>
    <tradeName>A1-15 TIP</tradeName>
    <deviceName>A1-15 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>A1-15</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:06:09.585Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800020107565</udiDi>
    <basicUdiDi>B-08800020107565</basicUdiDi>
    <tradeName>A1-12 TIP</tradeName>
    <deviceName>A1-12 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>A1-12</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:06:08.789Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800020107558</udiDi>
    <basicUdiDi>B-08800020107558</basicUdiDi>
    <tradeName>CP-16 TIP</tradeName>
    <deviceName>CP-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>CP-16</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:06:07.982Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800020107541</udiDi>
    <basicUdiDi>B-08800020107541</basicUdiDi>
    <tradeName>CP-25 TIP</tradeName>
    <deviceName>CP-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>CP-25</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:06:07.186Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800020107534</udiDi>
    <basicUdiDi>B-08800020107534</basicUdiDi>
    <tradeName>CP-49 TIP</tradeName>
    <deviceName>CP-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>CP-49</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:06:03.180Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800020107527</udiDi>
    <basicUdiDi>B-08800020107527</basicUdiDi>
    <tradeName>I-16 TIP</tradeName>
    <deviceName>I-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>I-16</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:06:02.478Z</lastUpdated>
  </row>
  <row>
    <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>
</eudamedExport>