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Accufuser Soft

by Woo Young Medical Co., Ltd. 61 variants

Ref CTS0005M-NModel CTS0005M

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

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-CTS0005MN3X Basic UDI-DI D-CTS0005MN3XUDI-DIDate8 Apr 2025RegisteredStatusActive

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  • Withdrawn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 Soft
Model / Reference
CTS0005M, CTS0005M-N
Primary DI / UDI-DI
D-CTS0005MN3X
Basic UDI-DI
B-CTS0005MN3X
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

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