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Biolox Forte

by DePuy Ireland UC 6 variants

Ref 9111-133Model BIOLOX Delta, BIOLOX Forte 12/14 Taper Femoral Heads - Ceramic

Active European Union

CE MDR

Valid until

4 Jun 2029

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 NumberMDR 776549 Date30 Jun 2026IssuedStatusActive expires 4 Jun 2029

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 776549 Active Supplemented

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    30 Jun 2026
    Expires
    4 Jun 2029
    Reason
    Change approved

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
12/14 Taper Femoral Heads - Ceramic
Model / Reference
BIOLOX Delta, BIOLOX Forte 12/14 Taper Femoral Heads - Ceramic, 9111-133
Primary DI / UDI-DI
10603295359166
Basic UDI-DI
0603295a0027895
EMDN Code
P090804050201 Ceramic femoral heads, total hip replacement
Device Class
Class III
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
IE-MF-000007377

Other devices from DePuy Ireland UC

See all devices from DePuy Ireland UC →

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