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Saima Global Farma S.L.: FDA-registered device maker in GIRONA Gerona, Spain, 7 PMA approvals

Name: Saima Global Farma S.L. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Saima Global Farma S.L. is registered with the FDA (registration 3033486016) in GIRONA Gerona, Spain. It lists 3 device types. The FDA files 7 PMA approvals under its listings, the newest dated August 29, 2017. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3033486016
Address: Carrer Ginestar 7, GIRONA Gerona, Spain, 17007
Owner or operator: SAIMA GLOBAL FARMA S.L. (10091581)
Roles: Repackager or relabeler
First device listed: October 17, 2024
Registered through: 2026
Brand names listed: DUROLANE, MONOVISC, ORTHOVISC, RESTYLANE DEFYNE, RESTYLANE KYSSE, RESTYLANE LYFT WITH LIDOCAINE, RESTYLANE REFYNE, SCULPTRA and more

Devices it lists

Device	Product code	Class	Role	Source
Acid, Hyaluronic, Intraarticular	MOZ	3	Repackager or relabeler	accessdata.fda.gov
Implant, Dermal, For Aesthetic Use	LMH	3	Repackager or relabeler	accessdata.fda.gov
Implant, Dermal, For Aesthetic Use In The Hands	PKY	3	Repackager or relabeler	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
August 29, 2017	P170007	DUROLANE	MOZ	15	December 23, 2025	accessdata.fda.gov
December 9, 2016	P140029	Restylane Refyne, Restylane Defyne	LMH	51	September 18, 2026	accessdata.fda.gov
February 25, 2014	P090031	MONOVISC	MOZ	15	August 8, 2023	accessdata.fda.gov
March 25, 2005	P040024	RESTYLANE INJECTABLE GEL	LMH	132	March 12, 2026	accessdata.fda.gov
August 3, 2004	P030050	SCULPTRA AND SCULPTRA AESTHETIC	LMH	54	September 17, 2026	accessdata.fda.gov
February 4, 2004	P030019	ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN	MOZ	23	August 28, 2026	accessdata.fda.gov
August 8, 1997	P940015	SYNVISC ONE	MOZ	51	January 2, 2025	accessdata.fda.gov

Compare with other makers

Updated December 23, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.