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Attune 2545-11-453

by Depuy (Ireland)

Ref 2545-11-453

Attune 2545-11-453 (254511453) is a Class I device made by Depuy (Ireland), registered in EUDAMED on 14 Sep 2026 (Basic UDI-DI 0603295a000568H) and listed in FDA GUDID since 23 Nov 2020 (UDI-DI 10603295499336), active as of 25 Oct 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0603295a000568H Basic UDI-DI 10603295499336UDI-DIDate14 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10603295499336 UDI-DI Date23 Nov 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0603295a000568H registered 14 Sep 2026 Active
  • FDA GUDID UDI-DI 10603295499336 listed 23 Nov 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10603295499336
  2. Registered EUDAMED 0603295a000568H

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  • Withdrawn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
Attune Knee System EUDAMED
Attune GUDID
Generic name
Surgical implant template, reusable
Model / Ref / Catalog
2545-11-453, 254511453
Primary DI / UDI-DI
10603295499336
Basic UDI-DI
0603295a000568H
Direct marketing DI
10603295499336
FDA product code
LXH
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Surgical implant template, reusable
Device class
Class I
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Surgical implant template, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER.

Other devices from Depuy (Ireland)

See all devices from Depuy (Ireland) →

Properties

  • Sterilise before use
  • Reusable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Premarket exempt
  • Lot / batch number
Other properties (20, all answered No)