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Prolene

by Ethicon, Inc. 8 variants

Ref 3DPL

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-USMF000013113000009KU Basic UDI-DI D-USMF000013113000009KUUDI-DIDate15 Sep 2026RegisteredStatusActive

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  • Withdrawn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
3DPL
Primary DI / UDI-DI
D-USMF000013113000009KU
Basic UDI-DI
B-USMF000013113000009KU
EMDN Code
P900202 Polypropylene surgical meshes
Device Class
Class IIb
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
US-MF-000013113
Authorised representative
Johnson & Johnson Medical GmbH DE-AR-000007712

Other devices from Ethicon Inc.

  • Coated VICRYL

    Class III

  • Prolene

    Class III

  • Perma-Hand

    Class III

  • Nurolon

    Class III

  • Mersilene

    Class III

  • Coated VICRYL

    Class III

See all devices from Ethicon Inc. →

Properties

  • Sterile
  • Implantable

Other properties (11)

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