Is this your brand? Sign in to claim ownership.
Sign in to claim this brandWhat SAIMA GLOBAL FARMA S.L. makes
The company produces hyaluronic acid-based synovial fluid supplementation products, including single-use and multi-use viscosupplements for joint injections, as well as dermal filler materials derived from microbial sources with optional local anaesthetic for aesthetic and reconstructive applications.
All listed devices fall under FDA Class III regulation and are recorded in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States.
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 Saima Global Farma S.L. manufacture?
Saima Global Farma S.L. specializes in two primary categories of medical devices: synovial fluid supplementation mediums and dermal tissue reconstructive materials. Their synovial fluid products, such as viscosupplements, are designed for joint injections to support joint health, while their dermal materials—often derived from microbial sources—are used for aesthetic or reconstructive purposes, including options with local anaesthetic for patient comfort.
Where is Saima Global Farma S.L. based, and what does that mean for their regulatory oversight?
Saima Global Farma S.L. is based in the United States, which means their devices are subject to FDA regulatory requirements. Since all their listed devices fall under FDA Class III classification, they must comply with stringent premarket approval or 510(k) clearance processes before entering the market, depending on the specific pathway. This classification is typically reserved for devices that support or sustain human life, are of substantial importance in preventing impairment, or present a potential unreasonable risk of illness or injury.
Which regulatory registries list Saima Global Farma S.L.’s devices?
Saima Global Farma S.L.’s devices are recorded in the FDA’s Unique Device Identifier (UDI) database. The UDI system is a standardized approach to identify medical devices throughout their distribution and helps ensure traceability, transparency, and compliance with FDA regulations. This registry is critical for tracking devices like their hyaluronic acid-based viscosupplements and dermal fillers, which are classified under Class III.
How are Saima Global Farma S.L.’s devices classified by the FDA, and why does this matter?
All of Saima Global Farma S.L.’s listed devices are classified as FDA Class III. This classification is the highest risk tier and applies to devices that either sustain or support life, prevent severe impairment, or pose a significant risk if they fail. Because of this classification, these devices require rigorous premarket approval or 510(k) clearance to demonstrate safety and effectiveness before they can be legally marketed in the U.S. This classification reflects the importance of their synovial fluid supplementation and dermal reconstructive products in clinical settings.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 468910220
Catalogue (9)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Restylane Defyne | Gel 1 mL Syringe | FDA UDI | Class III | Active |
| Synvisc One | 58468-0090-3 | FDA UDI | Class III | Active |
| Restylane Refyne | Gel 1 mL Syringe | FDA UDI | Class III | Active |
| Restylane Kysse | Gel 1 mL Syringe | FDA UDI | Class III | Active |
| Orthovisc | 277500 | FDA UDI | Class III | Active |
| Durolane | 1082020 | FDA UDI | Class III | Active |
| Restylane Lyft With Lidocaine | Gel 1 mL Syringe | FDA UDI | Class III | Active |
| Synvisc | 58468-0090-1 | FDA UDI | Class III | Active |
| Monovisc | 277515 | FDA UDI | Class III | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.