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implacross® E PE insert 10º 02343648

by implantcast GmbH

Ref 02343648Model CUPINS10XLEPE

implacross® E PE insert 10º 02343648 is a device classified as Class III in the EU and Class II in the US made by implantcast GmbH, registered in EUDAMED on 28 Oct 2026 (Basic UDI-DI B-04048844206970) and listed in FDA GUDID since 31 Aug 2018 (UDI-DI 04048844206970), active as of 7 Nov 2026.

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

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 NumberB-04048844206970 Basic UDI-DI 04048844206970UDI-DIDate28 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048844206970 UDI-DI Date31 Aug 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04048844206970 registered 28 Oct 2026 Active
  • FDA GUDID UDI-DI 04048844206970 listed 31 Aug 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04048844206970
  2. Registered EUDAMED B-04048844206970

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
implacross® E PE insert 10º
Generic name
Constrained polyethylene acetabular liner
Model / reference
02343648, CUPINS10XLEPE
Primary DI / UDI-DI
04048844206970
Basic UDI-DI
B-04048844206970
FDA product code
OQI
EMDN code
P090803040101 Standard polyethylene hip prostheses inserts
GMDN term
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
Lithuania
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II

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: Constrained polyethylene acetabular liner

Similar devices in this category

Other devices filed under STANDARD POLYETHYLENE HIP PROSTHESES INSERTS.

Other devices from implantcast GmbH

See all devices from implantcast GmbH →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)