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MENTOR Round Ultra High Profile Sterile Resterilizable Gel Breast Implant Sizer

by Mentor Medical Systems B.V. Netherlands EUDAMED

Ref RSZ-5455, RSZ-5295, RSZ-5240, RSZ-5590, RSZ-5350, RSZ-5480, RSZ-5320Model MENTOR Sterile Resterilizable Gel Breast Implant Sizers

EMDN P0680

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8717694a00006SD Basic UDI-DIDate13 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
MENTOR Sterile Resterilizable Gel Breast Implant Sizers
Model / Reference
MENTOR Sterile Resterilizable Gel Breast Implant Sizers, RSZ-5455, RSZ-5295, RSZ-5240, RSZ-5590, RSZ-5350, RSZ-5480, RSZ-5320
Primary DI / UDI-DI
08717694018328, 08717694018267, 08717694018243, 08717694018359, 08717694018281, 08717694018335, 08717694018274
Basic UDI-DI
8717694a00006SD
Direct Marketing DI
08717694018328
08717694018267
08717694018243
08717694018359
08717694018281
08717694018335
08717694018274
EMDN Code
P0680 Breast implants - accessories
Device Class
Class IIa
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000011681

Other devices from Mentor Medical Systems B.V.

See all devices from Mentor Medical Systems B.V. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (7)

  • EUDAMED 8a077586-6877-4acb-a152-683e2844b2ef 61 fields · synced 22 Oct 2026
  • EUDAMED 08717694018267|8717694A00006SD 61 fields · synced 17 May 2026
  • EUDAMED 08717694018243|8717694A00006SD 61 fields · synced 18 May 2026
  • EUDAMED 08717694018359|8717694A00006SD 61 fields · synced 18 May 2026
  • EUDAMED 08717694018281|8717694A00006SD 61 fields · synced 18 May 2026
  • EUDAMED 08717694018335|8717694A00006SD 61 fields · synced 18 May 2026
  • EUDAMED 08717694018274|8717694A00006SD 61 fields · synced 19 May 2026