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LINK Vario-Cup Prosthesis 107-220/65

by WALDEMAR LINK GmbH & Co. KG

Ref 107-220/65Model Bipolar head, uncemented, CoCrMo, UHMWPE

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

CE MDR

Valid until

9 Jul 2029

CE MDR certificate

FDA recalls

None found

in data synced 23 Oct 2026

Documents

1 certificate

Certifier DNV MEDCERT GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4026575-1-HSP-034001-X7 Basic UDI-DI 04026575329694UDI-DIDate12 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04026575329694 UDI-DI Date1 Nov 2015ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 13794GB450240710 Active

    Technical documentation EU MDR

    Certifier
    DNV MEDCERT GmbH 0482
    Issued
    10 Jul 2024
    Expires
    9 Jul 2029

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
LINK Vario-Cup Prosthesis
Generic Name
Bipolar femoral head outer component, hemiarthroplasty
Device Name
Vario-Cup System
Model / Ref / Catalog
107-220/65, Bipolar head, uncemented, CoCrMo, UHMWPE
Primary DI / UDI-DI
04026575329694
Basic UDI-DI
4026575-1-HSP-034001-X7
510(k) Number
FDA Product Code
KWY
EMDN Code
P0908040503 Hip prostheses, bi-articular cups
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

Cleared under the same submission (K781735)

Show all (12)

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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