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MENTOR CPX4, Medium Height Breast Tissue Expander, Textured

by Mentor United States EUDAMED

Ref 354-8221, 354-8225, 354-8223Model MENTOR CPX4 Breast Tissue Expanders - Textured, with Suture Tabs EMDN P900103

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0081317a0000745 Basic UDI-DIDate26 Feb 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
MENTOR CPX4 Breast Tissue Expanders - Textured, without Suture Tabs
Model / Reference
MENTOR CPX4 Breast Tissue Expanders - Textured, with Suture Tabs, 354-8221, 354-8225, 354-8223
Primary DI / UDI-DI
00081317009122, 00081317009160, 00081317009146
Basic UDI-DI
0081317a0000745
EMDN Code
P900103 Breast tissue expanders
Device Class
Class III
Medical Purpose
The intended purpose of the Mentor Contour Profile Tissue Expander devices is to create a subcutaneous or submuscular pocket that will allow for the insertion of a breast implant in reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures.

Manufacturer details

EUDAMED SRN
US-PR-000013792

Other devices from Mentor Corp.

See all devices from Mentor Corp. →

Properties & raw data

Show properties, registry sources and raw records
Other properties (1)
  • Sterile: No

Sources (3)

  • EUDAMED 67240dea-2ff8-4de4-9461-fdfc72c7a062 61 fields · synced 22 Oct 2026
  • EUDAMED 00081317009160|0081317A0000745 61 fields · synced 18 May 2026
  • EUDAMED 00081317009146|0081317A0000745 61 fields · synced 18 May 2026