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Stratafix Spiral Pds Plus

by Ethicon, LLC.

Ref SXPP1B434Model STRATAFIX PDS Plus Knotless Tissue Control Device Product Family

Active European Union

CE MDR

Valid until

19 Oct 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

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/MDR Number0705031a012054C Basic UDI-DI 10705031246553UDI-DIDate12 Mar 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 719659 Active Supplemented

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    14 May 2026
    Expires
    19 Oct 2028
    Reason
    Change approved

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
STRATAFIX Symmetric PDS Plus Knotless Tissue Control Device and STRATAFIX Spiral PDS Plus Knotless Tissue Control Device
Model / Reference
STRATAFIX PDS Plus Knotless Tissue Control Device Product Family, SXPP1B434
Primary DI / UDI-DI
10705031246553
Basic UDI-DI
0705031a012054C
EMDN Code
H010101030103 Polydioxanone monofilament with needle for tissue traction (‘barbed’) with antibacterial
Device Class
Class III
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
US-MF-000013111
Authorised representative
Johnson & Johnson Medical GmbH DE-AR-000007712

Other devices from Ethicon Inc.

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Properties

  • Sterile
  • Implantable
  • Incorporates Medicinal Product

Other properties (10)

  • 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