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Accufuser ABx

by Woo Young Medical Co., Ltd. 21 variants

Ref AB0400XL

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-AB0400XLSN Basic UDI-DI D-AB0400XLSNUDI-DIDate30 Sep 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
Accufuser ABx
Model / Reference
AB0400XL
Primary DI / UDI-DI
D-AB0400XLSN
Basic UDI-DI
B-AB0400XLSN
EMDN Code
A05010101 Elastomeric systems - fixed flow w/o additional bolus
Device Class
Class IIb
EU market of registration
France

Manufacturer details

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

Related devices

Category: Elastomeric infusion pump system

Other devices from Woo Young Medical Co., Ltd.

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

Properties

  • 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