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BiMobile 184-101/70

by WALDEMAR LINK GmbH & Co. KG

Ref 184-101/70Model Acetabular shell, TiCaP coating, uncemented, CoCrMo

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

CE MDR

Valid until

30 Jun 2027

CE MDR certificate

FDA recalls

None ongoing

2 closed

Documents

1 certificate

Certifier DNV MEDCERT GmbH

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/MDR EUDAMED Number4026575-1-HPP-101002-SU Basic UDI-DI 04026575174485UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04026575174485 UDI-DI Date24 May 2018ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 13691GB450220701 Expiring Expires in 237 days

    Technical documentation EU MDR

    Certifier
    DNV MEDCERT GmbH 0482
    Issued
    1 Jul 2022
    Expires
    30 Jun 2027

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0728-2019 FDA Class II initiated 4 Dec 2018
    • Terminated Z-0729-2019 FDA Class II initiated 4 Dec 2018

    The internal labeling included with these implants may include incorrect part numbers and could result in these incorrect labels being added to patient records.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
BiMobile
Generic Name
Acetabular shell
Device Name
BiMobile Dual Mobility System
Model / Ref / Catalog
184-101/70, Acetabular shell, TiCaP coating, uncemented, CoCrMo
Primary DI / UDI-DI
04026575174485
Basic UDI-DI
4026575-1-HPP-101002-SU
510(k) Number
FDA Product Code
LZO, MEH
EMDN Code
P090803050102 Uncemented double-mobility acetabular cups
GMDN Term
Acetabular shell
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
888.3353
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: Acetabular shell

Cleared under the same submission (K171273)

Show all (12)

Other devices from WALDEMAR LINK GmbH & Co. KG

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Properties

  • Sterile
  • Single Use
  • Implantable
  • CMR Substance
  • Prescription Use
  • Serial 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
  • Lot / Batch Number: No
  • Manufacturing Date: No