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MENTOR Round High Profile Xtra Sterile Resterilizable Gel Breast Implant Sizer

by Mentor Medical Systems B.V. 20 variants

Ref RSZSHPX595, RSZTHPX455, RSZTHPX620, RSZTHPX200, RSZTHPX255, RSZSHPX535, RSZTHPX515, RSZSHPX755, RSZSHPX180, RSZTHPX680, RSZTHPX150, RSZSHPX285, RSZTHPX765, RSZTHPX725, RSZSHPX150, RSZTHPX405, RSZSHPX700, RSZTHPX365, RSZTHPX470Model MENTOR Sterile Resterilizable Gel Breast Implant Sizers

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8717694a00006SD Basic UDI-DI Date13 Mar 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  • Withdrawn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 Sterile Resterilizable Gel Breast Implant Sizers
Model / Reference
MENTOR Sterile Resterilizable Gel Breast Implant Sizers, RSZSHPX595, RSZTHPX455, RSZTHPX620, RSZTHPX200, RSZTHPX255, RSZSHPX535, RSZTHPX515, RSZSHPX755, RSZSHPX180, RSZTHPX680, RSZTHPX150, RSZSHPX285, RSZTHPX765, RSZTHPX725, RSZSHPX150, RSZTHPX405, RSZSHPX700, RSZTHPX365, RSZTHPX470
Primary DI / UDI-DI
08717694024107, 08717694024268, 08717694024305, 08717694024176, 08717694024190, 08717694024091, 08717694024282, 08717694024138, 08717694023971, 08717694024312, 08717694024152, 08717694024015, 08717694024336, 08717694024329, 08717694023964, 08717694024244, 08717694024121, 08717694024237, 08717694024275
Basic UDI-DI
8717694a00006SD
Direct Marketing DI
08717694024107
08717694024268
08717694024305
08717694024176
08717694024190
08717694024091
08717694024282
08717694024138
08717694023971
08717694024312
08717694024152
08717694024015
08717694024336
08717694024329
08717694023964
08717694024244
08717694024121
08717694024237
08717694024275
EMDN Code
P0680 Breast implants - accessories
Device Class
Class IIa
EU 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

  • 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