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Dyflex

by Dynek Pty. Ltd.

Ref P405SModel DYFLEX 4/0 X 45CM ON 19MM 3/8 CIRCLE REVERSE PREMIUM CUTTING

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDD, withdrawn

Ended

Withdrawn

Date not published (CE MDD)

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 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-09331160033470 Basic UDI-DI 09331160033470UDI-DIDate28 Oct 2026RegisteredStatusWithdrawn No longer placed on the EU market

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  • Withdrawn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European Union — CE/MDD Withdrawn

Specification

EUDAMED

Device Name
P405S
Model / Reference
DYFLEX 4/0 X 45CM ON 19MM 3/8 CIRCLE REVERSE PREMIUM CUTTING, P405S
Primary DI / UDI-DI
09331160033470
Basic UDI-DI
B-09331160033470
EMDN Code
H010201020201 Polyester multifilament with needle for open surgery
Device Class
Class IIb

Manufacturer details

EUDAMED SRN
AU-MF-000036108
Authorised representative
Obelis s.a. BE-AR-000000106

Properties

  • Sterile
  • Implantable

Other properties (9)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No