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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>UNKNOWN</legislation>
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    <legislation>UNKNOWN</legislation>
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    <emdnDescription></emdnDescription>
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    <reference>SWS-EP-04</reference>
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    <reference>SWM10</reference>
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    <manufacturerName>Seawon Meditech Co.,Ltd.</manufacturerName>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T06:54:05.118Z</lastUpdated>
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    <basicUdiDi>B-08809272564713</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Seawon Meditech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007442</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
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    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SWM20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T06:54:05.102Z</lastUpdated>
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    <basicUdiDi>B-08809272564720</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Seawon Meditech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007442</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <emdnCode></emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS6601-05-10</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T06:54:05.079Z</lastUpdated>
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    <udiDi>08809272564737</udiDi>
    <basicUdiDi>B-08809272564737</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName></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>UNKNOWN</legislation>
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    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS6601-05-15</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T06:54:05.061Z</lastUpdated>
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    <udiDi>08809272564744</udiDi>
    <basicUdiDi>B-08809272564744</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS6601-05-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T06:54:05.037Z</lastUpdated>
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    <udiDi>08809272564751</udiDi>
    <basicUdiDi>B-08809272564751</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS6601-06</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T06:54:05.009Z</lastUpdated>
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    <udiDi>08809272564768</udiDi>
    <basicUdiDi>B-08809272564768</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS6601-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T06:54:04.988Z</lastUpdated>
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    <udiDi>08809272564775</udiDi>
    <basicUdiDi>B-08809272564775</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SWVP-8A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T06:54:04.963Z</lastUpdated>
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    <udiDi>08809272564782</udiDi>
    <basicUdiDi>B-08809272564782</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SWVP-8S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T06:54:04.939Z</lastUpdated>
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    <udiDi>08809272564799</udiDi>
    <basicUdiDi>B-08809272564799</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SWVP-8B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T06:54:04.916Z</lastUpdated>
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    <udiDi>08809272564805</udiDi>
    <basicUdiDi>B-08809272564805</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS6601-11</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T06:54:04.893Z</lastUpdated>
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    <udiDi>08809272564812</udiDi>
    <basicUdiDi>B-08809272564812</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SWVP-13T</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T06:54:04.877Z</lastUpdated>
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    <udiDi>08809272564829</udiDi>
    <basicUdiDi>B-08809272564829</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS6601-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T06:54:04.851Z</lastUpdated>
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    <udiDi>08809272564836</udiDi>
    <basicUdiDi>B-08809272564836</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS6601-03</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T06:54:04.825Z</lastUpdated>
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    <udiDi>08809272564843</udiDi>
    <basicUdiDi>B-08809272564843</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS6601-08</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T06:54:04.804Z</lastUpdated>
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    <udiDi>08809272564850</udiDi>
    <basicUdiDi>B-08809272564850</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS6601-09</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T06:54:04.784Z</lastUpdated>
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    <tradeName>SPASY</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS6601-04</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T06:54:04.760Z</lastUpdated>
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