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MobileLink Acetabular Cup System 183-101/62

by WALDEMAR LINK GmbH & Co. KG

Ref 183-101/62Model Acetabular shell, TiCaP coating, uncemented, Ti6Al4V, cluster hole

MobileLink Acetabular Cup System 183-101/62 is a device classified as Class III in the EU and Class II in the US made by WALDEMAR LINK GmbH & Co. KG, registered in EUDAMED on 3 Jun 2026 (Basic UDI-DI 4026575-1-HPP-103001-TF) with CE/MDR certificate 13690GB450220711 valid until 9 Jun 2027, cleared under FDA 510(k) K243927 on 16 May 2025 (1 earlier submission) and listed in FDA GUDID since 9 Sep 2019 (UDI-DI 04026575175550), active as of 25 Oct 2026.

Expiring Expiring in European Union. Active in United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

9 Jun 2027

CE MDR certificate

FDA recalls

None found

in data synced 25 Oct 2026

Documents

1 certificate

Certifier DNV MEDCERT GmbH

510(k) K243927

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4026575-1-HPP-103001-TF Basic UDI-DI 04026575175550UDI-DIDate3 Jun 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK243927 Date16 May 2025DecidedStatusActive
United StatesGUDID listing GUDID Number04026575175550 UDI-DI Date9 Sep 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4026575-1-HPP-103001-TF registered 3 Jun 2026 Active· +1 more in the status table
  • FDA 510(k) K243927 decided 16 May 2025 Active· +1 more in the status table
  • FDA GUDID UDI-DI 04026575175550 listed 9 Sep 2019 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 13690GB450220711 Expiring Amended Expires in 210 days

    Technical documentation EU MDR

    Certifier
    DNV MEDCERT GmbH 0482
    Issued
    11 Jul 2022
    Expires
    9 Jun 2027
    Reason
    Other

Timeline

6 dated events

  1. Cleared FDA 510(k) K182321
  2. Listed FDA GUDID 04026575175550
  3. Certificate issued EUDAMED 13690GB450220711
  4. Cleared FDA 510(k) K243927
  5. Registered EUDAMED 4026575-1-HPP-103001-TF
  6. Certificate expires EUDAMED 13690GB450220711

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Expiring
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
MobileLink Acetabular Cup System
Generic name
Acetabular shell
Model / Ref / Catalog
183-101/62, Acetabular shell, TiCaP coating, uncemented, Ti6Al4V, cluster hole
Primary DI / UDI-DI
04026575175550
Basic UDI-DI
4026575-1-HPP-103001-TF
510(k) Number
FDA product code
LZO, OQG, LPH, MEH
EMDN code
P090803010201 Primary implant uncemented metal acetabular cups
GMDN term
Acetabular shell
Device class
Class III EUDAMED
Class II GUDID
Regulation number
888.3353, 888.3358
EU registration type
Standard device
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 (K182321)

and 8 more cleared under K182321

Cleared under the same submission (K243927)

and 8 more cleared under K243927

Other devices from WALDEMAR LINK GmbH & Co. KG

See all devices from WALDEMAR LINK GmbH & Co. KG →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Serial number
  • Expiration date
Other properties (19, all answered No)