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25862805

by implantcast GmbH

Ref 25862805Model ICHEADBIOLOXD

25862805 is a device classified as Class III in the EU and Class II in the US made by implantcast GmbH, registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI B-04048844017309) and listed in FDA GUDID since 2 Jun 2026 (UDI-DI 04048844017309), active as of 7 Nov 2026.

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

CE MDD

Valid until

No date given

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

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04048844017309 Basic UDI-DI 04048844017309UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048844017309 UDI-DI Date2 Jun 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04048844017309 registered 6 Nov 2026 Active
  • FDA GUDID UDI-DI 04048844017309 listed 2 Jun 2026 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04048844017309
  2. Registered EUDAMED B-04048844017309

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  • Withdrawn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

Generic name
Ceramic femoral head prosthesis
Model / reference
25862805, ICHEADBIOLOXD
Primary DI / UDI-DI
04048844017309
Basic UDI-DI
B-04048844017309
FDA product code
OQI
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 registration type
Legacy device (under a directive)
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution
Sterilisation method
Radiation Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 04048844017309: EUDAMED states No, FDA GUDID states Yes.

Device class is stated on each registry's own scale: Class III in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Similar devices in this category

Other devices filed under CERAMIC FEMORAL HEADS, TOTAL HIP REPLACEMENT.

Other devices from implantcast GmbH

See all devices from implantcast GmbH →

Properties

  • Supplied sterile
  • Sterilise before use NoEUDAMEDYesGUDID
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)