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MENTOR CPX4, Medium Height Breast Tissue Expander, Suture Tabs, Textured

by Mentor United States EUDAMED

Ref 354-9221, 354-9224, 354-9226, 354-9225Model MENTOR CPX4 Breast Tissue Expanders - Textured, with Suture Tabs EMDN P900103

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0081317a0001544 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  • Withdrawn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, with Suture Tabs
Model / Reference
MENTOR CPX4 Breast Tissue Expanders - Textured, with Suture Tabs, 354-9221, 354-9224, 354-9226, 354-9225
Primary DI / UDI-DI
00081317009313, 00081317009344, 00081317009368, 00081317009351
Basic UDI-DI
0081317a0001544
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.

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Properties & raw data

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

Sources (4)

  • EUDAMED c7fce935-b6b3-4178-ace8-b5a209d1bb5f 61 fields · synced 22 Oct 2026
  • EUDAMED 00081317009344|0081317A0001544 61 fields · synced 17 May 2026
  • EUDAMED 00081317009368|0081317A0001544 61 fields · synced 17 May 2026
  • EUDAMED 00081317009351|0081317A0001544 61 fields · synced 19 May 2026