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Embrace Shoulder System 641-135/16

by WALDEMAR LINK GmbH & Co. KG

Ref 641-135/16Model Humeral stem, polished, cemented, Ti6Al4V, modular, revision

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

CE MDR

Valid until

12 Sep 2029

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier ITALCERT SRL

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-OEX-300038-X6 Basic UDI-DIDate10 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04026575261024 UDI-DIDate26 Jan 2023ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 057-00-02-MDR Active Supplemented

    Technical documentation EU MDR

    Notified body
    ITALCERT SRL 0426
    Issued
    13 May 2025
    Expires
    12 Sep 2029
    Reason
    Other

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  • Withdrawn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
Embrace Shoulder System
Generic Name
Uncoated shoulder humeral stem prosthesis
Device Name
LINK Embrace Shoulder System
Model / Reference
641-135/16, Humeral stem, polished, cemented, Ti6Al4V, modular, revision
Primary DI / UDI-DI
04026575261024
Basic UDI-DI
4026575-1-OEX-300038-X6
510(k) Number
FDA Product Code
PAO, PHX, HSD
EMDN Code
P0901040204 Shoulder prostheses revision stems
GMDN Term
Uncoated shoulder humeral stem prosthesis
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
888.3660, 888.3690
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: Uncoated shoulder humeral stem prosthesis

Cleared under the same submission (K212992)

Show all (12)

Other devices from WALDEMAR LINK GmbH & Co. KG

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Properties

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