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Acetabular Cups Trial Liner

by Limacorporate 9 variants

Ref 9058.85.458Model 80333902A015BM, Neutral Trial Liner - Head Dia. 32mm #MEDIUM

Acetabular Cups Trial Liner (9058.85.458) is a device classified as Class IIa in the EU and Class II in the US made by Limacorporate, registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI 80333902A015BM) and listed in FDA GUDID since 26 Nov 2016 (UDI-DI 08033390114653), active as of 7 Nov 2026.

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

CE MDR CE MDD

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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED Number80333902A015BM Basic UDI-DI 08033390114653UDI-DIDate29 Oct 2026RegisteredStatusActive
European UnionCE/MDR EUDAMED Number80333902A015BM Basic UDI-DI 08033390114653UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033390114653 UDI-DI Date26 Nov 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 80333902A015BM registered 29 Oct 2026 Active· +1 more in the status table
  • FDA GUDID UDI-DI 08033390114653 listed 26 Nov 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08033390114653
  2. Registered EUDAMED 80333902A015BM

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Neutral Trial Liner - Head Dia. 32mm #MEDIUM EUDAMED
Acetabular Cups GUDID
Generic name
Acetabulum prosthesis trial, prefabricated, reusable
Model / Ref / Catalog
80333902A015BM, 9058.85.458, Neutral Trial Liner - Head Dia. 32mm #MEDIUM, Trial Liner
Primary DI / UDI-DI
08033390114653
Basic UDI-DI
80333902A015BM, B-08033390114653
FDA product code
LPH, MBL
EMDN code
V06010101 Hip prostheses testing devices
GMDN term
Acetabulum prosthesis trial, prefabricated, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3358
EU registration type
Standard device
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
80333902A015BM
9058.85.458
Neutral Trial Liner - Head Dia. 32mm #MEDIUM
GUDID
Trial Liner
Device classEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Acetabulum prosthesis trial, prefabricated, reusable

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Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)