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Prolene

by Ethicon, LLC United States EUDAMED

Ref PMSK3Model PROLENE Polypropylene Mesh and PROLENE Soft Mesh

EMDN P900202

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0705031a0136757 Basic UDI-DIDate13 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 753200 Reissued

    Technical documentation EU MDR

    Notified body
    Notified body 2797
    Issued
    9 Sep 2026
    Expires
    8 Sep 2031

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Polypropylene Non-absorbable Synthetic Surgical Mesh
Model / Reference
PROLENE Polypropylene Mesh and PROLENE Soft Mesh, PMSK3
Primary DI / UDI-DI
10705031075740
Basic UDI-DI
0705031a0136757
EMDN Code
P900202 Polypropylene surgical meshes
Device Class
Class III
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
US-MF-000013112
Authorised representative
Johnson & Johnson Medical GmbH DE-AR-000007712

Other devices from Ethicon Inc.

See all devices from Ethicon Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 10705031075740|0705031A0136757 61 fields · synced 24 Oct 2026