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MENTOR CPX4, Tall Height Breast Tissue Expander, Textured

by Mentor 9 variants

Ref 354-8324NWModel MENTOR CPX4 Breast Tissue Expanders - Textured, with Suture Tabs

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0081317a000544E Basic UDI-DI 10081317034251UDI-DIDate19 Jun 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
MENTOR CPX4 Breast Tissue Expanders - Textured, without Suture Tabs
Model / Reference
MENTOR CPX4 Breast Tissue Expanders - Textured, with Suture Tabs, 354-8324NW
Primary DI / UDI-DI
10081317034251
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

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Properties

Other properties (1)

  • Sterile: No