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MENTOR CPX4, Low Height Breast Tissue Expander, Textured

by Mentor United States EUDAMED

Ref 354-8121NWModel MENTOR CPX4 Breast Tissue Expanders - Textured, with Suture Tabs

EMDN P900103

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0081317a000544E Basic UDI-DIDate19 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
MENTOR CPX4 Breast Tissue Expanders - Textured, without Suture Tabs
Model / Reference
MENTOR CPX4 Breast Tissue Expanders - Textured, with Suture Tabs, 354-8121NW
Primary DI / UDI-DI
10081317033957
Basic UDI-DI
0081317a000544E
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

Properties & raw data

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

Sources (1)

  • EUDAMED f5bd754f-ea59-48e8-b4c2-77e2f0fde8bf 61 fields · synced 23 Oct 2026