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Prolene

by Ethicon, LLC United States EUDAMED

Ref W8706Model PROLENE Suture

EMDN H010201010401,H010201010402

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0705031a012584Z Basic UDI-DIDate15 Dec 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 753191 Supplemented

    Technical documentation EU MDR

    Notified body
    Notified body 2797
    Issued
    19 Jun 2026
    Expires
    19 Jul 2028
    Reason
    Other

Specification

EUDAMED · synced 24 Oct 2026

Device Name
PROLENE Suture
Model / Reference
PROLENE Suture, W8706
Primary DI / UDI-DI
10705031128255
Basic UDI-DI
0705031a012584Z
EMDN Code
H010201010401,H010201010402
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 10705031128255|0705031A012584Z 61 fields · synced 24 Oct 2026