Skip to content

ic-bipolar head CoCrMo 21510046

by implantcast GmbH

Ref 21510046Model ICBIPOCOCRMOPE

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

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/MDD EUDAMED NumberB-04048844015695 Basic UDI-DI 04048844015695UDI-DIDate15 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048844015695 UDI-DI Date1 Oct 2020ListedStatusListed 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.

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  • Withdrawn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
ic-bipolar head CoCrMo
Generic Name
Bipolar femoral head outer component, hemiarthroplasty
Model / Reference
21510046, ICBIPOCOCRMOPE
Primary DI / UDI-DI
04048844015695
Basic UDI-DI
B-04048844015695
FDA Product Code
KWY
EMDN Code
P090804050102 Metal femoral heads, partial hip replacement
GMDN Term
Bipolar femoral head outer component, hemiarthroplasty
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
888.3390
EU market of registration
Germany
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

Other devices from implantcast GmbH

See all devices from implantcast GmbH →

Properties

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

Other properties (17)

  • 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
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No