Establishment Labs Holdings Inc's Comment on Supply Chain
The company operates two ISO-13485-certified manufacturing facilities in the Coyol Free Zone office park in Alajuela, Costa Rica. The original facility, established in 2016, encompasses approximately 28,000 square feet and has an annual production capacity exceeding 400,000 implants. It features energy-efficient systems that generate up to 80% of its energy and holds LEED Gold Certification. In 2024, the company completed the Sulàyöm Innovation Campus, a 100,000 square foot facility with an increased capacity of approximately 730,000 units per year, certified LEED Platinum and EDGE Advanced. Both facilities have received Carbon Neutral certification from the Costa Rican Ministry of Environment, Energy, and Telecommunications. In 2025, the U.S. Food and Drug Administration authorized these facilities to manufacture all Motiva USA PMA-approved products, expanding production capacity for the U.S. market. All manufacturing sites hold MDSAP certification, audited by the British Standards Institute, ensuring compliance with regulatory requirements from multiple international authorities.
Establishment Labs Holdings Inc's Comment on Supply Chain
The company operates two ISO-13485-certified manufacturing facilities in the Coyol Free Zone office park in Alajuela, Costa Rica. The original facility, established in 2016, encompasses approximately 28,000 square feet and has an annual production capacity exceeding 400,000 implants. It features energy-efficient systems that generate up to 80% of its energy and holds LEED Gold Certification. In 2024, the company completed the Sulàyöm Innovation Campus, a 100,000 square foot facility with an increased capacity of approximately 730,000 units per year, certified LEED Platinum and EDGE Advanced. Both facilities have received Carbon Neutral certification from the Costa Rican Ministry of Environment, Energy, and Telecommunications. In 2025, the U.S. Food and Drug Administration authorized these facilities to manufacture all Motiva USA PMA-approved products, expanding production capacity for the U.S. market. All manufacturing sites hold MDSAP certification, audited by the British Standards Institute, ensuring compliance with regulatory requirements from multiple international authorities.
Sources:
Establishment Labs Holdings Inc 's official press releases and regulatory filings; CSIMarket.com's supply-chain research; and the financial filings and press releases of other companies cited in this report.
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