MENTOR Smooth Round High Profile, Saline Breast Implant

Name: MENTOR Smooth Round High Profile, Saline Breast Implant
Brand: Mentor
SKU: 10081317028960

Unknown / Not in EUDAMED

Snapshot 2026-11-02 · Link to EUDAMED

UDI-DI 10081317028960Basic UDI-DI 0081317a000013R

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Class III · MDR · Mentor

Identification

Model: MENTOR Saline-Filled Breast Implants
EMDN: P0601010101
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: Yes
Measuring function: No
Reusable surgical: No

Certificates

MDR 745394

EU technical documentation assessment · unknown

Notified body: BSI Group The Netherlands B.V. (2797)

Valid from 2026-07-21 · Expiry 2029-10-09

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

Mentor

SRN US-MF-000013525

US · Irving, Texas

manufacturer

Authorised representative: MENTOR MEDICAL SYSTEMS B.V. (NL-AR-000012734)

Related UDI-DIs

Name	UDI-DI	Certificate
MENTOR Smooth Round High Profile, Saline Breast Implant	10081317029097	Unknown / Not in EUDAMED Snapshot 2026-11-02 · Link to EUDAMED
MENTOR Smooth Round High Profile, Saline Breast Implant	10081317029042	Unknown / Not in EUDAMED Snapshot 2026-11-02 · Link to EUDAMED
MENTOR Smooth Round High Profile, Saline Breast Implant	10081317029073	Unknown / Not in EUDAMED Snapshot 2026-11-02 · Link to EUDAMED
MENTOR Smooth Round High Profile, Saline Breast Implant	10081317029158	Unknown / Not in EUDAMED Snapshot 2026-11-02 · Link to EUDAMED
MENTOR Smooth Round High Profile, Saline Breast Implant	10081317028953	Unknown / Not in EUDAMED Snapshot 2026-11-02 · Link to EUDAMED
MENTOR Smooth Round High Profile, Saline Breast Implant	10081317029127	Unknown / Not in EUDAMED Snapshot 2026-11-02 · Link to EUDAMED
MENTOR Smooth Round High Profile, Saline Breast Implant	10081317029134	Unknown / Not in EUDAMED Snapshot 2026-11-02 · Link to EUDAMED
MENTOR Smooth Round High Profile, Saline Breast Implant	10081317029103	Unknown / Not in EUDAMED Snapshot 2026-11-02 · Link to EUDAMED
MENTOR Smooth Round High Profile, Saline Breast Implant	10081317029110	Unknown / Not in EUDAMED Snapshot 2026-11-02 · Link to EUDAMED
MENTOR Smooth Round High Profile, Saline Breast Implant	10081317029059	Unknown / Not in EUDAMED Snapshot 2026-11-02 · Link to EUDAMED
MENTOR Smooth Round High Profile, Saline Breast Implant	10081317029080	Unknown / Not in EUDAMED Snapshot 2026-11-02 · Link to EUDAMED
MENTOR Smooth Round High Profile, Saline Breast Implant	10081317028939	Unknown / Not in EUDAMED Snapshot 2026-11-02 · Link to EUDAMED

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Canonical device page: /device/mentor-smooth-round-high-profile-saline-breast-implant-8960 · UDI page: /udi/10081317028960

All devices from Mentor