<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00846338007669</udiDi>
    <basicUdiDi>0846338015-3928E8</basicUdiDi>
    <tradeName>Half Port</tradeName>
    <deviceName></deviceName>
    <manufacturerName>elliquence, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000024036</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K010399</emdnCode>
    <emdnDescription>SPINAL ENDOTHERAPY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>15-2928</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:55:07.969Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846338007324</udiDi>
    <basicUdiDi>0846338015-3928E8</basicUdiDi>
    <tradeName>Half Port</tradeName>
    <deviceName></deviceName>
    <manufacturerName>elliquence, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000024036</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K010399</emdnCode>
    <emdnDescription>SPINAL ENDOTHERAPY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>15-3924</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:55:07.947Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846338007331</udiDi>
    <basicUdiDi>0846338015-3928E8</basicUdiDi>
    <tradeName>Half Port</tradeName>
    <deviceName></deviceName>
    <manufacturerName>elliquence, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000024036</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K010399</emdnCode>
    <emdnDescription>SPINAL ENDOTHERAPY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>15-3925</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:55:07.924Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846338007348</udiDi>
    <basicUdiDi>0846338015-3928E8</basicUdiDi>
    <tradeName>Half Port</tradeName>
    <deviceName></deviceName>
    <manufacturerName>elliquence, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000024036</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K010399</emdnCode>
    <emdnDescription>SPINAL ENDOTHERAPY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>15-3926</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:55:07.901Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846338007355</udiDi>
    <basicUdiDi>0846338015-3928E8</basicUdiDi>
    <tradeName>Half Port</tradeName>
    <deviceName></deviceName>
    <manufacturerName>elliquence, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000024036</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K010399</emdnCode>
    <emdnDescription>SPINAL ENDOTHERAPY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>15-3927</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:55:07.877Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846338007362</udiDi>
    <basicUdiDi>0846338015-3928E8</basicUdiDi>
    <tradeName>Half Port</tradeName>
    <deviceName></deviceName>
    <manufacturerName>elliquence, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000024036</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K010399</emdnCode>
    <emdnDescription>SPINAL ENDOTHERAPY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>15-3928</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:55:07.826Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846338005726</udiDi>
    <basicUdiDi>0846338015-1642D5</basicUdiDi>
    <tradeName>Cup Forcep</tradeName>
    <deviceName></deviceName>
    <manufacturerName>elliquence, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000024036</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K010399</emdnCode>
    <emdnDescription>SPINAL ENDOTHERAPY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>15-1632</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:55:07.766Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846338005733</udiDi>
    <basicUdiDi>0846338015-1642D5</basicUdiDi>
    <tradeName>Cup Forcep</tradeName>
    <deviceName></deviceName>
    <manufacturerName>elliquence, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000024036</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K010399</emdnCode>
    <emdnDescription>SPINAL ENDOTHERAPY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>15-1641</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:55:07.743Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846338005740</udiDi>
    <basicUdiDi>0846338015-1642D5</basicUdiDi>
    <tradeName>Cup Forcep</tradeName>
    <deviceName></deviceName>
    <manufacturerName>elliquence, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000024036</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K010399</emdnCode>
    <emdnDescription>SPINAL ENDOTHERAPY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>15-1642</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:55:07.686Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846338005757</udiDi>
    <basicUdiDi>0846338015-1642D5</basicUdiDi>
    <tradeName>Cup Forcep</tradeName>
    <deviceName></deviceName>
    <manufacturerName>elliquence, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000024036</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K010399</emdnCode>
    <emdnDescription>SPINAL ENDOTHERAPY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>15-1643</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:55:07.620Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846338005764</udiDi>
    <basicUdiDi>0846338015-1642D5</basicUdiDi>
    <tradeName>Cup Forcep</tradeName>
    <deviceName></deviceName>
    <manufacturerName>elliquence, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000024036</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K010399</emdnCode>
    <emdnDescription>SPINAL ENDOTHERAPY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>15-1644</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:55:07.602Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846338005771</udiDi>
    <basicUdiDi>0846338015-1642D5</basicUdiDi>
    <tradeName>Cup Forcep</tradeName>
    <deviceName></deviceName>
    <manufacturerName>elliquence, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000024036</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K010399</emdnCode>
    <emdnDescription>SPINAL ENDOTHERAPY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>15-1651</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:55:07.577Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846338005788</udiDi>
    <basicUdiDi>0846338015-1642D5</basicUdiDi>
    <tradeName>Cup Forcep</tradeName>
    <deviceName></deviceName>
    <manufacturerName>elliquence, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000024036</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K010399</emdnCode>
    <emdnDescription>SPINAL ENDOTHERAPY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>15-1652</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:55:07.485Z</lastUpdated>
  </row>
  <row>
    <udiDi>08058964726735</udiDi>
    <basicUdiDi>805896472kyphokitVZ</basicUdiDi>
    <tradeName>Winch Bilateral Kyphoplasty Kit, 15 mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>G21 S.R.L.</manufacturerName>
    <manufacturerSrn>IT-PR-000041137</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>900016B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:46:00.354Z</lastUpdated>
  </row>
  <row>
    <udiDi>08058964726469</udiDi>
    <basicUdiDi>805896472kyphokitVZ</basicUdiDi>
    <tradeName>Winch Kyphoplasty Kit, 20 mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>G21 S.R.L.</manufacturerName>
    <manufacturerSrn>IT-PR-000041137</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>900018</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:45:48.702Z</lastUpdated>
  </row>
  <row>
    <udiDi>08058964727817</udiDi>
    <basicUdiDi>805896472kyphokitVZ</basicUdiDi>
    <tradeName>Winch Bilateral Kyphoplasty Kit, 20 mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>G21 S.R.L.</manufacturerName>
    <manufacturerSrn>IT-PR-000041137</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>900018B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:45:37.366Z</lastUpdated>
  </row>
  <row>
    <udiDi>08058964727589</udiDi>
    <basicUdiDi>805896472kyphokitVZ</basicUdiDi>
    <tradeName>Easy Winch Kit 15 mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>G21 S.R.L.</manufacturerName>
    <manufacturerSrn>IT-PR-000041137</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>900198</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:45:33.122Z</lastUpdated>
  </row>
  <row>
    <udiDi>08058964727596</udiDi>
    <basicUdiDi>805896472kyphokitVZ</basicUdiDi>
    <tradeName>Easy Winch Kit 20 mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>G21 S.R.L.</manufacturerName>
    <manufacturerSrn>IT-PR-000041137</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>900199</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:45:32.807Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809449090113</udiDi>
    <basicUdiDi>B-08809449090113</basicUdiDi>
    <tradeName>KYBS Kyphoplasty Balloon System</tradeName>
    <deviceName>KYBS Kyphoplasty Balloon System</deviceName>
    <manufacturerName>OK Medinet Korea</manufacturerName>
    <manufacturerSrn>KR-MF-000033858</manufacturerSrn>
    <authorisedRepresentativeName>SMB EUROPE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011981</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OKB1115, OTKS, OKMB</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:10:08.729Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846338007263</udiDi>
    <basicUdiDi>0846338011-2611BD</basicUdiDi>
    <tradeName>Trephine</tradeName>
    <deviceName></deviceName>
    <manufacturerName>elliquence, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000024036</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K010399</emdnCode>
    <emdnDescription>SPINAL ENDOTHERAPY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11-2611L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T03:46:18.533Z</lastUpdated>
  </row>
</eudamedExport>