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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
Website: www.gcaesthetics.com
LinkedIn: linkedin.com/company/gc-aesthetics
Facebook: facebook.com/GCAesthetics_Official-100605519152875
Email: [email protected]
Phone: +33 4 90 04 30 30
PRRC Contact: Bruno COTTIN
EUDAMED SRN: FR-MF-000008947
FDA FEI Number: —
DUNS Number: —

Catalogue (276)

Page 3 of 6

Device	Model / Reference	Registries	Class	Status
Eurosilicone S.a.s.	54/110	EUDAMED	Class IIb	Active
Eurosilicone S.a.s.	281/140	EUDAMED	Class III	Active
Anatomical Gel Filled Mammary Sizers	AS-HR2/275	EUDAMED	Class IIa	Active
Eurosilicone S.a.s	GFS-TMM2 10	EUDAMED	Class IIa	Active
Eurosilicone S.a.s	801/800	EUDAMED	Class III	Active
Anatomical Gel Filled Mammary Sizers	AS-HR3/250	EUDAMED	Class IIa	Active
Eurosilicone S.a.s.	54/035	EUDAMED	Class IIb	Active
Anatomical Gel Filled Mammary Sizers	AS-HR1/245	EUDAMED	Class IIa	Active
Eurosilicone S.a.s	TMM2/270	EUDAMED	Class III	Active
Eurosilicone S.a.s	812/800N	EUDAMED	Class III	Active
Eurosilicone S.a.s	GFS-TMF2 03	EUDAMED	Class IIa	Active
Anatomical Gel Filled Mammary Sizers	AS-HR3/720 03700469711543	EUDAMED	Class IIa	Active
Eurosilicone S.a.s	80/450	EUDAMED	Class III	Active
Eurosilicone S.a.s	GFS-TMF2 04	EUDAMED	Class IIa	Active
Eurosilicone S.a.s.	35M/325	EUDAMED	Class IIa	Active
Eurosilicone S.a.s	TMM2/140	EUDAMED	Class III	Active
Eurosilicone S.a.s	810/295N	EUDAMED	Class III	Active
Eurosilicone S.a.s.	12/800	EUDAMED	Class IIb	Active
Eurosilicone S.a.s.	54/150	EUDAMED	Class IIb	Active
Eurosilicone S.a.s.	26/200	EUDAMED	Class III	Active
Anatomical Gel Filled Mammary Sizers	AS-HR1/155	EUDAMED	Class IIa	Active
Eurosilicone S.a.s.	281/200	EUDAMED	Class III	Active
Eurosilicone S.a.s.	35R/240	EUDAMED	Class IIa	Active
Eurosilicone S.a.s	80/200	EUDAMED	Class III	Active
Eurosilicone S.a.s	811/650	EUDAMED	Class III	Active
Eurosilicone S.a.s.	28/140	EUDAMED	Class III	Active
Eurosilicone S.a.s	TML3/270	EUDAMED	Class III	Active
Eurosilicone S.a.s	TMF3/430	EUDAMED	Class III	Active
Anatomical Gel Filled Mammary sizers	AS-HR2/165	EUDAMED	Class IIa	Active
Eurosilicone S.a.s	TMM3/190	EUDAMED	Class III	Active
Anatomical Gel Filled Mammary Sizers	AS-MR2/415	EUDAMED	Class IIa	Active
Eurosilicone S.a.s.	26/180	EUDAMED	Class III	Active
Eurosilicone S.a.s.	54/060	EUDAMED	Class IIb	Active
Eurosilicone S.a.s	TMF1/140	EUDAMED	Class III	Active
Eurosilicone S.a.s	80/500	EUDAMED	Class III	Active
Eurosilicone S.a.s	GFS-TMF2 01	EUDAMED	Class IIa	Active
Anatomical Gel Filled Mammary Sizers	AS-LR2/135	EUDAMED	Class IIa	Active
Eurosilicone S.a.s	TMM3/370	EUDAMED	Class III	Active
Healena	GCA-HL-ST-01	EUDAMED	Class I	Active
Eurosilicone S.a.s	GFS-TMM3 09	EUDAMED	Class IIa	Active
Eurosilicone S.a.s	812/120N	EUDAMED	Class III	Active
Anatomical Gel Filled Mammary Sizers	AS-HR3/645	EUDAMED	Class IIa	Active
Eurosilicone S.a.s	812/180N	EUDAMED	Class III	Active
Eurosilicone S.a.s	TMM1/125	EUDAMED	Class III	Active
Eurosilicone S.a.s	810/500N	EUDAMED	Class III	Active
Eurosilicone S.a.s	812/220N	EUDAMED	Class III	Active
Eurosilicone S.a.s	802/650N	EUDAMED	Class III	Active
Eurosilicone S.a.s	TMM2/350	EUDAMED	Class III	Active
Eurosilicone S.a.s.	54/140	EUDAMED	Class IIb	Active
Anatomical Gel Filled Mammary Sizers	AS-LR2/440	EUDAMED	Class IIa	Active

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