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EUROSILICONE SAS

France·FR-MF-000008947

Last updated September 18, 2026

What EUROSILICONE SAS makes

EUROSILICONE SAS manufactures anatomical gel-filled mammary sizers, which are used for preoperative breast surgery planning and patient consultation. These devices provide a realistic simulation of breast implant sizes and shapes to aid in decision-making for surgical outcomes.

The company’s products are classified under EU Medical Device Regulations as Class I, Class IIa, Class IIb, and Class III devices, depending on their intended use and risk level. These devices are registered in the EUDAMED database, the official European Union registry for medical devices, and the manufacturer is based in France.

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 EUROSILICONE SAS manufacture?

EUROSILICONE SAS specializes in anatomical gel-filled mammary sizers. These devices are designed to simulate breast implant sizes and shapes, helping surgeons and patients plan preoperative breast surgery and consult on expected outcomes. The focus is on providing a realistic, tactile representation to aid decision-making.

Where is EUROSILICONE SAS based, and what regulatory region does it operate in?

EUROSILICONE SAS is based in France and operates under the European Union’s medical device regulations. Its products are registered in the EUDAMED database, which is the official EU registry for tracking medical devices authorized within the region.

Which EU Medical Device Regulation (MDR) classes apply to EUROSILICONE SAS’s devices?

EUROSILICONE SAS’s anatomical gel-filled mammary sizers are classified under different risk levels in the EU MDR framework: Class I, Class IIa, Class IIb, and Class III. The classification depends on factors like the intended use, potential risks to patients, and the duration of contact with the body, ensuring appropriate regulatory oversight.

Are EUROSILICONE SAS’s devices listed in any official medical device registries?

Yes, EUROSILICONE SAS’s devices are registered in the EUDAMED database. This is the official European Union registry for medical devices, where manufacturers list their authorized products to ensure transparency, traceability, and compliance with EU medical device regulations.

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

Information

Country
France
Address
Z.I. de la Peyrolière , APT Cedex, France
Phone
+33 4 90 04 30 30
PRRC Contact
Bruno COTTIN
EUDAMED SRN
FR-MF-000008947
FDA FEI Number
—
DUNS Number
—

Catalogue (276)

Page 5 of 6
DeviceModel / ReferenceRegistriesClassStatus
Eurosilicone S.a.s TML3/240
EUDAMED
Class IIIActive
Eurosilicone S.a.s. 54/090
EUDAMED
Class IIbActive
Eurosilicone S.a.s. 281/400
EUDAMED
Class IIIActive
Eurosilicone S.a.s. 35M/240
EUDAMED
Class IIaActive
Eurosilicone S.a.s. 28/500
EUDAMED
Class IIIActive
Anatomical Gel Filled Mammary Sizers AS-HR1/135
EUDAMED
Class IIaActive
Anatomical Gel Filled Mammary Sizers AS-MR3/205
EUDAMED
Class IIaActive
Eurosilicone S.a.s. 12/300
EUDAMED
Class IIbActive
Anatomical Gel Filled Mammary Sizers AS-MR3/345
EUDAMED
Class IIaActive
Eurosilicone S.a.s. 26/400
EUDAMED
Class IIIActive
Eurosilicone S.a.s. 35M/120
EUDAMED
Class IIaActive
Eurosilicone S.a.s. 261/350
EUDAMED
Class IIIActive
Eurosilicone S.a.s 802/400N
EUDAMED
Class IIIActive
Eurosilicone S.a.s TMF1/120
EUDAMED
Class IIIActive
Eurosilicone S.a.s TML3/175
EUDAMED
Class IIIActive
Eurosilicone S.a.s. ES.14/200
EUDAMED
Class IIbActive
Eurosilicone S.a.s. 26/280
EUDAMED
Class IIIActive
Eurosilicone S.a.s 811/450
EUDAMED
Class IIIActive
Eurosilicone S.a.s. 37R/300
EUDAMED
Class IIaActive
Eurosilicone S.a.s. 14/650
EUDAMED
Class IIbActive
Eurosilicone S.a.s. 37R/160
EUDAMED
Class IIaActive
Eurosilicone S.a.s 81/350
EUDAMED
Class IIIActive
Eurosilicone S.a.s. ES.19/250
EUDAMED
Class IIbActive
Eurosilicone S.a.s TML2/225
EUDAMED
Class IIIActive
Eurosilicone S.a.s GFS-TMF3 06
EUDAMED
Class IIaActive
Eurosilicone S.a.s. 261/260
EUDAMED
Class IIIActive
Eurosilicone S.a.s GFS-TMM2 07
EUDAMED
Class IIaActive
Eurosilicone S.a.s TML2/145
EUDAMED
Class IIIActive
Eurosilicone S.a.s TML1/180
EUDAMED
Class IIIActive
Eurosilicone S.a.s. 28/450
EUDAMED
Class IIIActive
Eurosilicone S.a.s. 38000
EUDAMED
Class IIbActive
Eurosilicone S.a.s TMF2/410
EUDAMED
Class IIIActive
Eurosilicone S.a.s GFS-TMM3 04
EUDAMED
Class IIaActive
Eurosilicone S.a.s. 14/800
EUDAMED
Class IIbActive
Eurosilicone S.a.s. 26/375
EUDAMED
Class IIIActive
Eurosilicone S.a.s. 325/01
EUDAMED
Class IIbActive
Eurosilicone S.a.s 805/480N
EUDAMED
Class IIIActive
Eurosilicone S.a.s 81/500
EUDAMED
Class IIIActive
Eurosilicone S.a.s 812/375N
EUDAMED
Class IIIActive
Eurosilicone S.a.s GFS-TMM2 04
EUDAMED
Class IIaActive
Eurosilicone S.a.s. 37R/350
EUDAMED
Class IIaActive
Eurosilicone S.a.s. 281/650
EUDAMED
Class IIIActive
Eurosilicone S.a.s GFS-TMM2 01
EUDAMED
Class IIaActive
Eurosilicone S.a.s. 261/500
EUDAMED
Class IIIActive
Anatomical Gel Filled Mammary Sizers AS-LR3/415
EUDAMED
Class IIaActive
Anatomical Gel Filled Mammary Sizers AS-MR3/685
EUDAMED
Class IIaActive
Anatomical Gel Filled Mammary Sizers AS-MR2/595
EUDAMED
Class IIaActive
Eurosilicone S.a.s 80/350
EUDAMED
Class IIIActive
Eurosilicone S.a.s TMF3/385
EUDAMED
Class IIIActive
Eurosilicone S.a.s TMF3/275
EUDAMED
Class IIIActive

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