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Establishment Labs S.A.

Last updated May 23, 2026

What Establishment Labs S.A. makes

Establishment Labs S.A. manufactures silicone gel-filled breast implants with smooth surfaces, designed for reconstructive and cosmetic procedures. Their portfolio also includes skin-port tissue expanders, which are used in staged breast reconstruction to gradually expand tissue before implant placement.

The company’s devices are classified as Class III under FDA regulations, indicating they require premarket approval due to their substantial risk. These products are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. medical device reporting requirements.

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 Establishment Labs S.A. manufacture?

Establishment Labs S.A. specializes in silicone gel-filled breast implants with smooth surfaces, primarily used for reconstructive and cosmetic procedures. They also produce skin-port tissue expanders, which are essential in staged breast reconstruction to gradually expand tissue before implant placement.

Where is Establishment Labs S.A. based?

The company is based in the United States, as indicated by its regulatory and manufacturing context.

Which regulatory registries list Establishment Labs S.A.’s devices?

The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database, which ensures traceability and compliance with U.S. medical device reporting requirements. This registry helps track and monitor devices for regulatory purposes.

How are Establishment Labs S.A.’s devices classified under U.S. regulations?

The devices manufactured by Establishment Labs S.A. fall under Class III classification by the FDA. This classification is assigned to high-risk medical devices that require premarket approval due to their potential risks and benefits, ensuring rigorous evaluation before market authorization.

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

Information

Country: US
Address: —
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 853166098

Catalogue (176)

Page 4 of 4

Device	Model / Reference	Registries	Class	Status
Motiva® SmoothSilk® Round Breast Implant	RSF-335+	FDA UDI	Class III	Active
Motiva® SmoothSilk® Round Ergonomix Breast Implant	ERSM-185	FDA UDI	Class III	Active
Motiva® SmoothSilk® Round Breast Implant	RSD-425+Q	FDA UDI	Class III	Active
Motiva® SmoothSilk® Round Ergonomix Breast Implant	ERSD-285	FDA UDI	Class III	Active
Motiva® SmoothSilk® Round Ergonomix Breast Implant	ERSF-550Q	FDA UDI	Class III	Active
Motiva® SmoothSilk® Round Breast Implant	RSF-355+Q	FDA UDI	Class III	Active
Motiva® SmoothSilk® Round Ergonomix Breast Implant	ERSF-375Q	FDA UDI	Class III	Active
Motiva® SmoothSilk® Round Ergonomix Breast Implant	ERSF-335Q	FDA UDI	Class III	Active
Flora™ Tissue Expander SMOOTHSILK®	M-11-300	FDA UDI	U	Active
Motiva® SmoothSilk® Round Breast Implant	RSF-275+Q	FDA UDI	Class III	Active
Motiva® SmoothSilk® Round Breast Implant	RSD-360+Q	FDA UDI	Class III	Active
Motiva® SmoothSilk® Round Breast Implant	RSM-275+Q	FDA UDI	Class III	Active
Motiva® SmoothSilk® Round Ergonomix Breast Implant	ERSD-265Q	FDA UDI	Class III	Active
Motiva® SmoothSilk® Round Ergonomix Breast Implant	ERSF-315Q	FDA UDI	Class III	Active
Motiva® SmoothSilk® Round Ergonomix Breast Implant	ERSD-205	FDA UDI	Class III	Active
Motiva® SmoothSilk® Round Breast Implant	RSD-230+	FDA UDI	Class III	Active
Motiva® SmoothSilk® Round Breast Implant	RSF-425+Q	FDA UDI	Class III	Active
Motiva® SmoothSilk® Round Breast Implant	RSF-450+	FDA UDI	Class III	Active
Motiva® SmoothSilk® Round Ergonomix Breast Implant	ERSM-430Q	FDA UDI	Class III	Active
Motiva® SmoothSilk® Round Breast Implant	RSD-265+Q	FDA UDI	Class III	Active
Motiva® SmoothSilk® Round Ergonomix Breast Implant	ERSM-430	FDA UDI	Class III	Active
Motiva® SmoothSilk® Round Ergonomix Breast Implant	ERSM-160Q	FDA UDI	Class III	Active
Motiva® SmoothSilk® Round Ergonomix Breast Implant	ERSD-320	FDA UDI	Class III	Active
Motiva® SmoothSilk® Round Ergonomix Breast Implant	ERSD-525	FDA UDI	Class III	Active
Motiva® SmoothSilk® Round Ergonomix Breast Implant	ERSM-360	FDA UDI	Class III	Active
Motiva® SmoothSilk® Round Breast Implant	RSF-625+Q	FDA UDI	Class III	Active

Related Companies

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Establishment Labs S.a. Coyol Alajuela · CR FEI 3012883202