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Accufuser Omnibus

by Woo Young Medical Co., Ltd. South Korea EUDAMED

Ref SP030615M

EMDN A05010202

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-SP030615MSL Basic UDI-DIDate19 Oct 2022RegisteredStatusActive

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 25 Oct 2026

Device Name
Accufuser Omnibus
Model / Reference
SP030615M
Primary DI / UDI-DI
D-SP030615MSL
Basic UDI-DI
B-SP030615MSL
EMDN Code
A05010202 Elastomeric systems - variable flow with additional bolus
Device Class
Class IIb
Market of Registration
France

Manufacturer details

EUDAMED SRN
KR-MF-000022134
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Woo Young Medical Co., Ltd.

See all devices from Woo Young Medical Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Administering Medicine
  • Measuring Function
Other properties (8)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED c15ce7c1-6a7b-4b52-a1d4-9904b0d87fd5 61 fields · synced 25 Oct 2026