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Actis 101011090

by Depuy (Ireland)

Ref 1010-11-090Model ACTIS DUOFIX 12/14 taper cementless proximal femoral stems

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

CE MDR

Valid until

2 Jan 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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberMDR 776552 Date9 Sep 2026IssuedStatusActive expires 2 Jan 2029
United StatesGUDID listing GUDID Number10603295380498 UDI-DI Date20 May 2016ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 776552 Active Supplemented

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    9 Sep 2026
    Expires
    2 Jan 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  • Withdrawn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
Actis
Generic Name
Coated femoral stem prosthesis, one-piece
Device Name
12/14 taper cementless proximal femoral stems
Model / Ref / Catalog
ACTIS DUOFIX 12/14 taper cementless proximal femoral stems EUDAMED
1010-11-090 EUDAMED
101011090 GUDID
Description
ACTIS DUOFIX HIP PROSTHESIS (FEMORAL STEM 12/14 TAPER CEMENTLESS SIZE 9 STD COLLAR) CE
Primary DI / UDI-DI
10603295380498
Basic UDI-DI
0603295a002528K
FDA Product Code
MEH, LPH, KWY, KWL
EMDN Code
P090804010201 Uncemented femoral stems for primary implant, with fixed neck, straight
GMDN Term
Coated femoral stem prosthesis, one-piece
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
888.3353, 888.3358, 888.3390, 888.3360
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
ACTIS DUOFIX 12/14 taper cementless proximal femoral stems
1010-11-090
GUDID
101011090
Device ClassEUDAMED
Class III
GUDID
Class II

Related devices

Category: Coated femoral stem prosthesis, one-piece

Other devices from Depuy (Ireland)

See all devices from Depuy (Ireland) →

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