Skip to content

Pds II

by Ethicon, LLC. 370 variants

Ref X1252EModel PDS II Suture

Active European Union

CE MDR

Valid until

12 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 Number0705031a007965T Basic UDI-DI 10705031111592UDI-DIDate15 Dec 2025RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 719656 Active Supplemented

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    15 Apr 2025
    Expires
    12 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  • Withdrawn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
PDS II Suture
Model / Reference
PDS II Suture, X1252E
Primary DI / UDI-DI
10705031111592
Basic UDI-DI
0705031a007965T
EMDN Code
H010101010101, H010101010102
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.

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