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Spasy

by Seawon Meditech Co., Ltd. South Korea EUDAMED

Ref SWM-3

EMDN A019011

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08809272562276 Basic UDI-DIDate14 Apr 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
SWM-3
Primary DI / UDI-DI
08809272562276
Basic UDI-DI
B-08809272562276
EMDN Code
A019011 Intraosseous infusion and vertebroplasty infusion needles and kits
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000007442
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Related devices

Category: Intraosseous infusion kit

Other devices from Seawon Meditech Co., Ltd.

See all devices from Seawon Meditech Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (10)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED b5831ecc-2302-4f0a-9bde-aedb5db03b92 61 fields · synced 24 Oct 2026