<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08809272562313</udiDi>
    <basicUdiDi>B-08809272562313</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName>SPASY</deviceName>
    <manufacturerName>Seawon Meditech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007442</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SWS15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:13:08.661Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809272562306</udiDi>
    <basicUdiDi>B-08809272562306</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName>SPASY</deviceName>
    <manufacturerName>Seawon Meditech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007442</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SWMP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:13:07.858Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809272562290</udiDi>
    <basicUdiDi>B-08809272562290</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName>SPASY</deviceName>
    <manufacturerName>Seawon Meditech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007442</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SWMVP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:13:03.868Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809272562283</udiDi>
    <basicUdiDi>B-08809272562283</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName>SPASY</deviceName>
    <manufacturerName>Seawon Meditech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007442</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SWM-4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:13:03.058Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809272562276</udiDi>
    <basicUdiDi>B-08809272562276</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName>SPASY</deviceName>
    <manufacturerName>Seawon Meditech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007442</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SWM-3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:13:02.264Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809272562269</udiDi>
    <basicUdiDi>B-08809272562269</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName>SPASY</deviceName>
    <manufacturerName>Seawon Meditech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007442</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SWM-2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:13:01.453Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809272562252</udiDi>
    <basicUdiDi>B-08809272562252</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName>SPASY</deviceName>
    <manufacturerName>Seawon Meditech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007442</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SWM-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:12:57.463Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809272561460</udiDi>
    <basicUdiDi>B-08809272561460</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName>SPASY</deviceName>
    <manufacturerName>Seawon Meditech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007442</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JMSPASY-BI</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:12:43.065Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809272561453</udiDi>
    <basicUdiDi>B-08809272561453</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName>SPASY</deviceName>
    <manufacturerName>Seawon Meditech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007442</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JMSWSNT23</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:12:42.258Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809272561422</udiDi>
    <basicUdiDi>B-08809272561422</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName>SPASY</deviceName>
    <manufacturerName>Seawon Meditech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007442</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JMSWSNS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:12:38.246Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809272561415</udiDi>
    <basicUdiDi>B-08809272561415</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName>SPASY</deviceName>
    <manufacturerName>Seawon Meditech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007442</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JMSWS20F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:12:37.466Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809272561446</udiDi>
    <basicUdiDi>B-08809272561446</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName>SPASY</deviceName>
    <manufacturerName>Seawon Meditech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007442</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JMSWSNT20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:12:36.657Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809272561439</udiDi>
    <basicUdiDi>B-08809272561439</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName>SPASY</deviceName>
    <manufacturerName>Seawon Meditech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007442</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JMSWSNT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:12:35.944Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809272561408</udiDi>
    <basicUdiDi>B-08809272561408</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName>SPASY</deviceName>
    <manufacturerName>Seawon Meditech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007442</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JMSWS20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:12:18.984Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809272561392</udiDi>
    <basicUdiDi>B-08809272561392</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName>SPASY</deviceName>
    <manufacturerName>Seawon Meditech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007442</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JMSWS15F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:12:18.183Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809272561385</udiDi>
    <basicUdiDi>B-08809272561385</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName>SPASY</deviceName>
    <manufacturerName>Seawon Meditech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007442</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JMSWS15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:12:17.390Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809272561378</udiDi>
    <basicUdiDi>B-08809272561378</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName>SPASY</deviceName>
    <manufacturerName>Seawon Meditech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007442</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JMSWS10F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:12:16.576Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809272561361</udiDi>
    <basicUdiDi>B-08809272561361</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName>SPASY</deviceName>
    <manufacturerName>Seawon Meditech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007442</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JMSWS10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:12:12.573Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809272561354</udiDi>
    <basicUdiDi>B-08809272561354</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName>SPASY</deviceName>
    <manufacturerName>Seawon Meditech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007442</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JMSWMP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:12:11.772Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809272561347</udiDi>
    <basicUdiDi>B-08809272561347</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName>SPASY</deviceName>
    <manufacturerName>Seawon Meditech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007442</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JMSWM-4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:12:10.980Z</lastUpdated>
  </row>
</eudamedExport>