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ASHCOM™ Shoulder 01.04441.004

by Zimmer, Inc.

Ref 01.04441.004

ASHCOM™ Shoulder 01.04441.004 is a device classified as Class I in the EU and Class II in the US made by Zimmer, Inc., registered in EUDAMED on 19 Oct 2026 (Basic UDI-DI 889024PMKS) and listed in FDA GUDID since 27 Jul 2017 (UDI-DI 00889024226821), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number889024PMKS Basic UDI-DI 00889024226821UDI-DIDate19 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889024226821 UDI-DI Date27 Jul 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 889024PMKS registered 19 Oct 2026 Active
  • FDA GUDID UDI-DI 00889024226821 listed 27 Jul 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00889024226821
  2. Registered EUDAMED 889024PMKS

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  • Withdrawn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
ASHCOM™ Shoulder
Generic name
Joint prosthesis implantation kit, reusable
Device name
ASHCOM® Shoulder, stem inserter
Model / Ref / Catalog
01.04441.004
Primary DI / UDI-DI
00889024226821
Basic UDI-DI
889024PMKS
Direct marketing DI
00889024226821
FDA product code
KWS, PHX, HSD, PAO, KWT
EMDN code
P0901040201 Shoulder prostheses non modular stems
GMDN term
Joint prosthesis implantation kit, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3660, 888.3690, 888.3650
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Joint prosthesis implantation kit, reusable

Similar devices in this category

Other devices filed under SHOULDER PROSTHESES NON MODULAR STEMS.

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)