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Accufuser M16C

by Woo Young Medical Co., Ltd. 14 variants

Ref MC1248XL-NModel MC1248XL

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-MC1248XLNQK Basic UDI-DI D-MC1248XLNQKUDI-DIDate9 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  • Withdrawn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 M16C
Model / Reference
MC1248XL, MC1248XL-N
Primary DI / UDI-DI
D-MC1248XLNQK
Basic UDI-DI
B-MC1248XLNQK
EMDN Code
A05010201 Elastomeric systems - variable 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