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Self Centering 1035-65-000

by Depuy Orthopaedics, Inc.

Ref 1035-65-000Model SELF-CENTERING Bi-Polar Head

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

CE MDR

Valid until

17 Aug 2030

CE MDR certificate

FDA recalls

None found

in data synced 23 Oct 2026

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0603295a004038G Basic UDI-DI 10603295003519UDI-DIDate25 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10603295003519 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 781955 Active Supplemented

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    15 Jul 2026
    Expires
    17 Aug 2030
    Reason
    Change approved

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

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  • Withdrawn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
Self-Centering EUDAMED
Self Centering GUDID
Generic Name
Bipolar femoral head outer component, hemiarthroplasty
Model / Ref / Catalog
1035-65-000, SELF-CENTERING Bi-Polar Head, 103565000
Primary DI / UDI-DI
10603295003519
Basic UDI-DI
0603295a004038G
510(k) Number
FDA Product Code
KWY
EMDN Code
P090804050199 Femoral heads for primary implant of partial prostheses - other
GMDN Term
Bipolar femoral head outer component, hemiarthroplasty
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
888.3390
Market of Registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

Related devices

Category: Bipolar femoral head outer component, hemiarthroplasty

Cleared under the same submission (K812672)

Show all (12)

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Properties

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

Other properties (17)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: 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