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    <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>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>JMSWS20F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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    <deviceName>SPASY</deviceName>
    <manufacturerName>Seawon Meditech Co.,Ltd.</manufacturerName>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:12:36.657Z</lastUpdated>
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    <udiDi>08809272561439</udiDi>
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    <tradeName>SPASY</tradeName>
    <deviceName>SPASY</deviceName>
    <manufacturerName>Seawon Meditech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007442</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>JMSWSNT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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    <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>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>JMSWS20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:12:18.984Z</lastUpdated>
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    <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>
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    <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>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>JMSWS15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:12:17.390Z</lastUpdated>
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    <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>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>JMSWS10F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:12:16.576Z</lastUpdated>
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    <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>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
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    <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>
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    <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>
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    <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>
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    <udiDi>08809272561330</udiDi>
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    <tradeName>SPASY</tradeName>
    <deviceName>SPASY</deviceName>
    <manufacturerName>Seawon Meditech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007442</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <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-3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:12:10.175Z</lastUpdated>
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    <udiDi>08809272561323</udiDi>
    <basicUdiDi>B-08809272561323</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-2T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:12:06.180Z</lastUpdated>
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    <udiDi>08809272561316</udiDi>
    <basicUdiDi>B-08809272561316</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-2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:12:05.383Z</lastUpdated>
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    <udiDi>08809272561309</udiDi>
    <basicUdiDi>B-08809272561309</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-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:12:04.576Z</lastUpdated>
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    <udiDi>08809272561293</udiDi>
    <basicUdiDi>B-08809272561293</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>JMSPAVER13</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:12:03.779Z</lastUpdated>
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    <udiDi>08033860001605</udiDi>
    <basicUdiDi>8033860VERTFT05CL</basicUdiDi>
    <tradeName>VERTEBROSTEEL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KMFVT1312000C-A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:17:29.477Z</lastUpdated>
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    <udiDi>08033860001780</udiDi>
    <basicUdiDi>8033860VERTFT05CL</basicUdiDi>
    <tradeName>VERTEBROSTEEL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KMFVT1310000C-A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:17:29.270Z</lastUpdated>
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    <udiDi>08033860001889</udiDi>
    <basicUdiDi>8033860VERTFT05CL</basicUdiDi>
    <tradeName>VERTEBROSTEEL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KMFVT1315000C-A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:17:29.109Z</lastUpdated>
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    <udiDi>08033860002176</udiDi>
    <basicUdiDi>8033860VERTFT05CL</basicUdiDi>
    <tradeName>VERTEBROSTEEL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KMFVT1310025C-A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:17:28.796Z</lastUpdated>
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    <udiDi>08033860002534</udiDi>
    <basicUdiDi>8033860VERTFT05CL</basicUdiDi>
    <tradeName>VERTEBROSTEEL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KMFVT1512000C-A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:17:28.356Z</lastUpdated>
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