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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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MENTOR Sterile Resterilizable Gel… — 230 UDI-DI variants, MDR

MD Atlas
MENTOR MEDICAL SYSTEMS B.V.

Data from EUDAMED, last updated May 30, 2026

MENTOR Sterile Resterilizable Gel Breast Implant Sizers

8717694a00006SD

230 UDI-DI variants

MDR [Regulation (EU) 2017/745 on medical devices]Class IIa

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Manufacturer: MENTOR MEDICAL SYSTEMS B.V.

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 8717694a00006SD
Device name: MENTOR Sterile Resterilizable Gel Breast Implant Sizers
Device model: MENTOR Sterile Resterilizable Gel Breast Implant Sizers
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Version date: Mar 13, 2026

Manufacturer & authorised representative

Manufacturer

Name: MENTOR MEDICAL SYSTEMS B.V.
SRN: NL-MF-000011681
Country: Netherlands
Email: EUDAMED_Enquiries@its.jnj.com

Variants by status

UDI-DI variants

230 UDI-DI variants

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Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

MENTOR Round Ultra High Profile Sterile Resterilizable Gel Breast Implant Sizer08717694018236
MENTOR Round Ultra High Profile Sterile Resterilizable Gel Breast Implant Sizer08717694018359
MENTOR Round Ultra High Profile Sterile Resterilizable Gel Breast Implant Sizer08717694018335
MENTOR Round Ultra High Profile Sterile Resterilizable Gel Breast Implant Sizer08717694018205
MENTOR Round Ultra High Profile Sterile Resterilizable Gel Breast Implant Sizer08717694018274