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BiMobile 184-280/11

by WALDEMAR LINK GmbH & Co. KG

Ref 184-280/11Model Acetabular liner, uncemented, vitamin E highly crosslinked UHMWPE

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

CE MDR

Valid until

30 Jun 2027

CE MDR certificate

FDA recalls

1 ongoing

This device is named in the recall

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-101005-T5 Basic UDI-DI 04026575230730UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04026575230730 UDI-DI Date26 Aug 2019ListedStatusListed 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

1 recall · 1 ongoing · FDA

    • Ongoing Z-1219-2024 FDA Class II initiated 22 Jan 2024

    Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it should reference G may cause a delay in surgery

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  • Withdrawn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
Constrained polyethylene acetabular liner
Device Name
BiMobile Dual Mobility System
Model / Ref / Catalog
184-280/11, Acetabular liner, uncemented, vitamin E highly crosslinked UHMWPE
Primary DI / UDI-DI
04026575230730
Basic UDI-DI
4026575-1-HPP-101005-T5
510(k) Number
FDA Product Code
MEH, LZO
EMDN Code
P0908030502 Double-mobility acetabular components inserts
GMDN Term
Constrained polyethylene acetabular liner
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: Constrained polyethylene acetabular liner

Cleared under the same submission (K190535)

Show all (12)

Other devices from WALDEMAR LINK GmbH & Co. KG

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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