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UDI Compass

MENTOR Smooth Round SPECTRUM Saline Breast Implant

Unknown / Not in EUDAMED

Snapshot 2026-11-02 · Link to EUDAMED

UDI-DI 10081317030529Basic UDI-DI 0081317a000023T

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Class III · MDR · Mentor

Identification

Model
MENTOR SPECTRUM Breast Implants
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

NameUDI-DICertificate
MENTOR Smooth Round SPECTRUM Saline Breast Implant10081317030468
Unknown / Not in EUDAMED

Snapshot 2026-11-02 · Link to EUDAMED

MENTOR Smooth Round SPECTRUM Saline Breast Implant10081317030550
Unknown / Not in EUDAMED

Snapshot 2026-11-02 · Link to EUDAMED

MENTOR Smooth Round SPECTRUM Saline Breast Implant10081317030536
Unknown / Not in EUDAMED

Snapshot 2026-11-02 · Link to EUDAMED

MENTOR Smooth Round SPECTRUM Saline Breast Implant10081317030482
Unknown / Not in EUDAMED

Snapshot 2026-11-02 · Link to EUDAMED

MENTOR Smooth Round SPECTRUM Saline Breast Implant10081317030475
Unknown / Not in EUDAMED

Snapshot 2026-11-02 · Link to EUDAMED

MENTOR Smooth Round SPECTRUM Saline Breast Implant10081317030499
Unknown / Not in EUDAMED

Snapshot 2026-11-02 · Link to EUDAMED

MENTOR Smooth Round SPECTRUM Saline Breast Implant10081317030543
Unknown / Not in EUDAMED

Snapshot 2026-11-02 · Link to EUDAMED

MENTOR Smooth Round SPECTRUM Saline Breast Implant10081317030512
Unknown / Not in EUDAMED

Snapshot 2026-11-02 · Link to EUDAMED

MENTOR Smooth Round SPECTRUM Saline Breast Implant10081317030505
Unknown / Not in EUDAMED

Snapshot 2026-11-02 · Link to EUDAMED

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/mentor-smooth-round-spectrum-saline-breast-implant-0529 · UDI page: /udi/10081317030529

All devices from Mentor