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Biolox Delta Modular Head 36mm MEDIUM 0.0mm 12/14 Eurocone Taper 104.3605

by Corin Ltd

Ref 104.3605Model Trinity Ceramic Modular Heads

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05055196964389 Basic UDI-DI 05055196964389UDI-DIDate22 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055196964389 UDI-DI Date17 Aug 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
BIOLOX delta Ceramic Modular Head Ø36mm 12/14 Medium 0 EUDAMED
Biolox Delta Modular Head 36mm MEDIUM 0.0mm 12/14 Eurocone Taper GUDID
Generic Name
Ceramic femoral head prosthesis
Device Name
Trinity BIOLOX delta ceramic modular femoral heads for use in Trinity Acetabular System
Model / Ref / Catalog
104.3605, Trinity Ceramic Modular Heads
Primary DI / UDI-DI
05055196964389
Basic UDI-DI
B-05055196964389
510(k) Number
FDA Product Code
LZO, MEH
EMDN Code
P090804050201 Ceramic femoral heads, total hip replacement
GMDN Term
Ceramic femoral head prosthesis
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
888.3353
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilization Method
Radiation Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

Related devices

Category: Ceramic femoral head prosthesis

Cleared under the same submission (K110087)

Show all (12)

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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