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Radene

by Dynek Pty. Ltd.

Ref R405Model RADENE 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Withdrawn Withdrawn in European Union.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Was authorized under CE MDD, withdrawn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Withdrawn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-09331160031209 Basic UDI-DI 09331160031209UDI-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  • Withdrawn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European Union — CE/MDD Withdrawn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
R405
Model / Reference
RADENE 4/0 X 45CM ON 19MM 3/8 CIRCLE REVERSE PREMIUM CUTTING, R405
Primary DI / UDI-DI
09331160031209
Basic UDI-DI
B-09331160031209
EMDN Code
H010201010601 Polyvinylidene fluoride and derivatives monofilament with needle
Device Class
Class III

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