MENTOR MEDICAL SYSTEMS B.V.

Netherlands NL-MF-000011681 Last updated 17 Sep 2026

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Devices: 175
Registries: EUDAMED
FDA recalls: 0

Catalogue175

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What MENTOR MEDICAL SYSTEMS B.V. makes

Mentor Medical Systems B.V. manufactures sterile, resterilizable gel breast implants and implant sizers, including round and contour profile designs with varying profiles (high, moderate, ultra-high). The portfolio includes cohesive gel implants and sizing tools for preoperative planning in breast augmentation and reconstruction procedures.

The company’s devices are classified as Class III (breast implants) and Class IIa (expander/implant combinations) under EU regulations, with records maintained in the EUDAMED database. The manufacturer is based in the Netherlands.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Mentor Medical Systems B.V. manufacture?

Mentor Medical Systems B.V. specializes in sterile, resterilizable gel breast implants and implant sizers. Their portfolio includes round and contour profile implants with varying profiles (such as high, moderate, and ultra-high) as well as cohesive gel implants. These devices are designed for use in breast augmentation and reconstruction procedures, with some products serving as preoperative planning tools.

Where is Mentor Medical Systems B.V. based?

The company is headquartered in the Netherlands. This location is relevant for regulatory compliance, as it aligns with EU medical device regulations and reporting requirements, including the EUDAMED database.

Which regulatory registries list Mentor Medical Systems B.V.’s devices?

Mentor Medical Systems B.V.’s devices are listed in the EUDAMED database, which is the official European Union registry for medical devices. This registry is used to track device information, including classification, authorizations, and market surveillance data, ensuring transparency and compliance with EU regulations.

How are Mentor Medical Systems B.V.’s devices classified under EU regulations?

Mentor’s breast implants fall under Class III classification, which applies to high-risk devices like implants that may support or replace a vital body function. Their expander/implant combinations are classified as Class IIa, indicating moderate risk but still requiring regulatory oversight. These classifications determine the level of scrutiny and documentation required for market authorization and post-market surveillance.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: Netherlands
Address: 2, Zernikedreef, Leiden, Netherlands
Website: its.jnj.com
Email: [email protected]
EUDAMED SRN: NL-MF-000011681

Catalogue175

MENTOR Round Moderate Plus Profile Sterile Resterilizable Gel Breast Implant Sizer Ref RSZ-2501

MENTOR CPG 322 Sterile Resterilizable Gel Breast Implant Sizer Ref RSZ-1055

MENTOR Round High Profile Xtra Sterile Resterilizable Gel Breast Implant Sizer Ref RSZSHPX490

MENTOR CPG 333 Sterile Resterilizable Gel Breast Implant Sizer Ref RSZ-4135

MENTOR Round Ultra High Profile Sterile Resterilizable Gel Breast Implant Sizer Ref RSZ-5535

MENTOR Round High Profile Sterile Resterilizable Gel Breast Implant Sizer Ref RSZ-1754

MENTOR Round High Profile Xtra Sterile Resterilizable Gel Breast Implant Sizer Ref RSZSHPX650

MENTOR CPG 333 Sterile Resterilizable Gel Breast Implant Sizer Ref RSZ-4115

MENTOR Round High Profile Sterile Resterilizable Gel Breast Implant Sizer Ref RSZ-4004

MENTOR Round High Profile Sterile Resterilizable Gel Breast Implant Sizer Ref RSZ-6004

MENTOR Round Moderate Plus Profile Xtra Sterile Resterilizable Gel Breast Implant Sizer Ref RSZMPX755

MENTOR CPG 313 Sterile Resterilizable Gel Breast Implant Sizer Ref RSZ-1006

MENTOR CPG 311 Sterile Resterilizable Gel Breast Implant Sizer Ref RSZ-0125

MENTOR Round Moderate Plus Profile Xtra Sterile Resterilizable Gel Breast Implant Sizer Ref RSZMPX215

MENTOR CPG 321 Sterile Resterilizable Gel Breast Implant Sizer Ref RSZ-1108

MENTOR CPG 313 Sterile Resterilizable Gel Breast Implant Sizer Ref RSZ-0956

MENTOR CPG 311 Sterile Resterilizable Gel Breast Implant Sizer Ref RSZ-0150

MENTOR CPG 333 Sterile Resterilizable Gel Breast Implant Sizer Ref RSZ-4120

MENTOR SILTEX CONTOUR PROFILE BECKER 35 Expander / Gel Breast Implant Cohesive II Ref 324-1205

MENTOR Round High Profile Sterile Resterilizable Gel Breast Implant Sizer Ref RSZ-4504

MENTOR CPG 313 Sterile Resterilizable Gel Breast Implant Sizer Ref RSZ-1056

MENTOR CPG 312 Sterile Resterilizable Gel Breast Implant Sizer Ref RSZ-1457

MENTOR Round Moderate Plus Profile Xtra Sterile Resterilizable Gel Breast Implant Sizer Ref RSZMPX545

MENTOR CPG 313 Sterile Resterilizable Gel Breast Implant Sizer Ref RSZ-1506

MENTOR CPG 321 Sterile Resterilizable Gel Breast Implant Sizer Ref RSZ-1208

MENTOR Round High Profile Xtra Sterile Resterilizable Gel Breast Implant Sizer Ref RSZTHPX285

MENTOR Round High Profile Sterile Resterilizable Gel Breast Implant Sizer Ref RSZ-5504

MENTOR SILTEX CONTOUR PROFILE BECKER 35 Expander / Gel Breast Implant Cohesive II Ref 324-1055

MENTOR CPG 321 Sterile Resterilizable Gel Breast Implant Sizer Ref RSZ-1358

MENTOR Round High Profile Xtra Sterile Resterilizable Gel Breast Implant Sizer Ref RSZSHPX235

MENTOR CPG 333 Sterile Resterilizable Gel Breast Implant Sizer Ref RSZ-4145

MENTOR CPG 331 Sterile Resterilizable Gel Breast Implant Sizer Ref RSZ-1453

MENTOR Round High Profile Xtra Sterile Resterilizable Gel Breast Implant Sizer Ref RSZSHPX465

MENTOR CPG 321 Sterile Resterilizable Gel Breast Implant Sizer Ref RSZ-1608

MENTOR Round Ultra High Profile Sterile Resterilizable Gel Breast Implant Sizer Ref RSZ-5185

MENTOR Round High Profile Sterile Resterilizable Gel Breast Implant Sizer Ref RSZ-5004

MENTOR Round Moderate Plus Profile Sterile Resterilizable Gel Breast Implant Sizer Ref RSZ-1751

MENTOR Round Moderate Plus Profile Sterile Resterilizable Gel Breast Implant Sizer Ref RSZ-1251

MENTOR CPG 321 Sterile Resterilizable Gel Breast Implant Sizer Ref RSZ-0958

MENTOR Round High Profile Sterile Resterilizable Gel Breast Implant Sizer Ref RSZ-2004

MENTOR CPG 322 Sterile Resterilizable Gel Breast Implant Sizer Ref RSZ-1155

MENTOR Round High Profile Xtra Sterile Resterilizable Gel Breast Implant Sizer Ref RSZSHPX450

MENTOR Round High Profile Sterile Resterilizable Gel Breast Implant Sizer Ref RSZ-1254

MENTOR Round High Profile Sterile Resterilizable Gel Breast Implant Sizer Ref RSZ-6504

MENTOR CPG 322 Sterile Resterilizable Gel Breast Implant Sizer Ref RSZ-1405

MENTOR CPG 321 Sterile Resterilizable Gel Breast Implant Sizer Ref RSZ-1308

MENTOR CPG 321 Sterile Resterilizable Gel Breast Implant Sizer Ref RSZ-1458

MENTOR Round High Profile Xtra Sterile Resterilizable Gel Breast Implant Sizer Ref RSZSHPX790

MENTOR Round High Profile Sterile Resterilizable Gel Breast Implant Sizer Ref RSZ-3504

MENTOR Round Moderate Plus Profile Xtra Sterile Resterilizable Gel Breast Implant Sizer Ref RSZMPX325

What MENTOR MEDICAL SYSTEMS B.V. makes

Frequently asked questions

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