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MENTOR Smooth Round Moderate Plus Profile Saline Breast Implant

by Mentor EUDAMEDGUDID

Active European Union and United States

Ref 350-2300Model MENTOR Saline-Filled Breast Implants

Regulatory status

as of 26 Oct 2026

Recall ongoing. 1 ongoing FDA recall. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0081317a000043X Basic UDI-DIDate20 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00081317001393 UDI-DIDate17 Sep 2014ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates: none listed in EUDAMED

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-0367-2022 FDA Class II initiated 30 Sep 2021

    Due to a manufacturing issue, Implant may have a potentially weakened area on the base patch portion of the implant which may cause leakage/deflation of the affected device.

    • Terminated Z-2070-2017 FDA Class II initiated 27 Mar 2017

    Missing Dome Pack accessory.

Specification

EUDAMED · GUDID

Trade Name
MENTOR Smooth Round Moderate Plus Profile Saline Breast Implant EUDAMED
MENTOR Smooth Round Moderate Plus Profile GUDID
Generic Name
Saline-filled breast implant, unstructured, smooth-surface
Device Name
MENTOR Saline-Filled Breast Implants
Model / Ref / Catalog
MENTOR Saline-Filled Breast Implants, 350-2300, 3502300
Primary DI / UDI-DI
00081317001393
PMA Number
FDA Product Code
FWM
GMDN Term
Saline-filled breast implant, unstructured, smooth-surface
Regulation Number
878.3530
Medical Purpose
The intended purpose of the Mentor Saline-Filled Breast Implants is to replace missing breast tissue or to enhance a breast in females undergoing breast augmentation (non-medical) or breast reconstruction (medical purpose)
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
MENTOR Saline-Filled Breast Implants
350-2300
GUDID
3502300
SterileEUDAMED
No
GUDID
Yes

Manufacturer details

EUDAMED SRN
US-PR-000013792

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