Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033486016

FEI Number

3033486016

Entity Name

SAIMA GLOBAL FARMA S.L.

City/State/Country

GIRONA Gerona, ES

Establishment Address

Carrer Ginestar 7, GIRONA Gerona 17007, ES

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

SAIMA GLOBAL FARMA S.L. (Owner Number: 10091581)

Owner / Operator Contact Address

C/ GINESTAR 7, POLIG. IND. DOMENY NORD, GIRONA, ES-CT 17007, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P030019

All Registered Proprietary Names

DUROLANE RESTYLANE KYSSE RESTYLANE DEFYNE RESTYLANE REFYNE MONOVISC SCULPTRA RESTYLANE LYFT WITH LIDOCAINE ORTHOVISC

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MOZ	Acid, Hyaluronic, Intraarticular	Unknown	Class 3	N/A	2024-10-17
LMH	Implant, Dermal, For Aesthetic Use	Unknown	Class 3	N/A	2025-06-16
MOZ	Acid, Hyaluronic, Intraarticular	Unknown	Class 3	N/A	2024-10-17
LMH	Implant, Dermal, For Aesthetic Use	Unknown	Class 3	N/A	2026-02-11
PKY	Implant, Dermal, For Aesthetic Use In The Hands	Unknown	Class 3	N/A	2025-06-16
LMH	Implant, Dermal, For Aesthetic Use	Unknown	Class 3	N/A	2025-06-16
MOZ	Acid, Hyaluronic, Intraarticular	Unknown	Class 3	N/A	2024-10-17

Official Correspondent

Maria Angels Moral

US Agent Details

FDAIMPORTS.COM LLC Email: registration@fdaimports.com Phone: (410) 2202800

Related Public Records

Same Entity

SAIMA GLOBAL FARMA S.L.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033486016. Last updated year: 2026. Please use registration number 3033486016 when referencing this establishment in official correspondence.