MENTOR MEDICAL SYSTEMS B.V.
NL-MF-000011681 · Netherlands · Leiden
MENTOR MEDICAL SYSTEMS B.V. is registered in the European database on medical devices as a manufacturer, with 230 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 230 |
|---|
Most frequent device types declared: MENTOR Sterile Resterilizable Gel Breast Implant Sizers.
Among these devices, 230 are declared sterile.
Devices declared under this manufacturer
- MENTOR CPG 311 Sterile Resterilizable Gel Breast Implant Sizer
- MENTOR CPG 312 Sterile Resterilizable Gel Breast Implant Sizer
- MENTOR CPG 313 Sterile Resterilizable Gel Breast Implant Sizer
- MENTOR CPG 321 Sterile Resterilizable Gel Breast Implant Sizer
- MENTOR CPG 322 Sterile Resterilizable Gel Breast Implant Sizer
- MENTOR CPG 323 Sterile Resterilizable Gel Breast Implant Sizer
- MENTOR CPG 331 Sterile Resterilizable Gel Breast Implant Sizer
- MENTOR CPG 332 Sterile Resterilizable Gel Breast Implant Sizer
- MENTOR CPG 333 Sterile Resterilizable Gel Breast Implant Sizer
- MENTOR Round High Profile Sterile Resterilizable Gel Breast Implant Si
- MENTOR Round High Profile Xtra Sterile Resterilizable Gel Breast Impla
- MENTOR Round Moderate Plus Profile Sterile Resterilizable Gel Breast I
Showing 12 of 230 declared devices.
Catalogue references include RSZ-0130, RSZ-1002, RSZ-4125, RSZ-4145, RSZ-5001, RSZ-6004.
European nomenclature codes declared: P0680.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 230 |
| Country of registration | Netherlands |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 230 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | MENTOR MEDICAL SYSTEMS, B.V. |
What it holds in Canada
| Licences on record | 5 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| Class 4 devices | 4 |
| First licensed | 2006-10-20 |
Licence types: Device Family (4), Device Group Family (1).
Licensed under: MENTOR MEMORYGEL CPG GEL BREAST IMPLANTS COHES, MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IM, MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IM, STERILE RESTERILIZABLE GEL BREAST IMPLANT SIZE, MEMORYGEL SILTEX BECKER EXPANDER/BREAST IMPLAN.
North American profile: Canada only. MENTOR MEDICAL SYSTEMS B.V. holds a Canadian licence but was not found in the U.S. register.