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Biolox Delta 1365-36-340

by Depuy Orthopaedics, Inc.

Ref 1365-36-340Model BIOLOX Forte 12/14 Taper Femoral Heads - Ceramic

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

4 Jun 2029

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberMDR 776549 Date30 Jun 2026IssuedStatusActive expires 4 Jun 2029
United StatesGUDID listing GUDID Number10603295033646 UDI-DI Date24 Mar 2015ListedStatusListed GUDID: in commercial distribution

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

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Biolox Delta
Generic Name
Ceramic femoral head prosthesis
Device Name
12/14 Taper Femoral Heads - Ceramic
Model / Ref / Catalog
1365-36-340, BIOLOX Forte 12/14 Taper Femoral Heads - Ceramic, 136536340
Primary DI / UDI-DI
10603295033646
Basic UDI-DI
0603295a0027895
FDA Product Code
MRA, LZO
EMDN Code
P090804050201 Ceramic femoral heads, total hip replacement
GMDN Term
Ceramic femoral head prosthesis
Device Class
Class III
Regulation Number
888.3353
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Related devices

Category: Ceramic femoral head prosthesis

Other devices from Depuy Orthopaedics, Inc.

See all devices from Depuy Orthopaedics, Inc. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No