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Accufuser Plus

by Woo Young Medical Co., Ltd. 491 variants

Ref SM0560L

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 23 Oct 2026. What this means

Overview

The Accufuser Plus device is a Class IIb medical device used for the precise placement of sutures in surgical procedures. Developed by Woo Young Medical Co., Ltd., it features a sterile and durable design, making it an ideal tool for various medical applications.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-SM0560LSU Basic UDI-DI D-SM0560LSUUDI-DIDate17 Mar 2023RegisteredStatusActive

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  • Withdrawn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

Model / Reference
SM0560L
Primary DI / UDI-DI
D-SM0560LSU
Basic UDI-DI
B-SM0560LSU
EMDN Code
A05010102 Elastomeric systems - fixed flow with 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

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