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MobiliT Cup HDM2858

by Corin Ltd

Ref HDM2858Model MobiliT cup ECiMa insert

MobiliT Cup HDM2858 is a device classified as Class III in the EU and Class II in the US made by Corin Ltd, registered in EUDAMED on 18 Sep 2026 (Basic UDI-DI B-05056139239229), cleared under FDA 510(k) K191831 on 16 Jan 2020 and listed in FDA GUDID since 8 Dec 2022 (UDI-DI 05056139239229), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K191831

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05056139239229 Basic UDI-DI 05056139239229UDI-DIDate18 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05056139239229 UDI-DI Date8 Dec 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK191831 Date16 Jan 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05056139239229 registered 18 Sep 2026 Active
  • FDA 510(k) K191831 decided 16 Jan 2020 Active
  • FDA GUDID UDI-DI 05056139239229 listed 8 Dec 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K191831
  2. Listed FDA GUDID 05056139239229
  3. Registered EUDAMED B-05056139239229

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
ECiMa insert for 28mm head diameter 58 EUDAMED
MobiliT Cup GUDID
Generic name
Non-constrained polyethylene acetabular liner
Device name
ECiMa insert for use in total hip arthroplasty
Model / Ref / Catalog
HDM2858, MobiliT cup ECiMa insert
Primary DI / UDI-DI
05056139239229
Basic UDI-DI
B-05056139239229
510(k) Number
FDA product code
LZO, MEH
EMDN code
P090803040101 Standard polyethylene hip prostheses inserts
GMDN term
Non-constrained polyethylene acetabular liner
Device class
Class III EUDAMED
Class II GUDID
Regulation number
888.3353
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilisation method
Radiation Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 05056139239229: EUDAMED states No, FDA GUDID states Yes.

Device class is stated on each registry's own scale: Class III 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: Non-constrained polyethylene acetabular liner

Cleared under the same submission (K191831)

and 8 more cleared under K191831

Similar devices in this category

Other devices filed under STANDARD POLYETHYLENE HIP PROSTHESES INSERTS.

Other devices from Corin Ltd

See all devices from Corin Ltd →

Properties

  • Supplied sterile
  • Sterilise before use NoEUDAMEDYesGUDID
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)