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Sign in to claim this brandFCL HEALTH SOLUTIONS LTD
US
Last updated May 27, 2026
What FCL HEALTH SOLUTIONS LTD makes
FCL Health Solutions Ltd manufactures intra-articular viscosupplementation products designed to restore joint lubrication, including hyaluronic acid-based injectables for osteoarthritis treatment. These devices include single-dose and multi-dose formulations for knee joints, as well as dermal fillers for soft tissue augmentation. The portfolio also covers synthetic gel-based alternatives for joint viscosity enhancement.
All listed devices fall under FDA Class III regulation and are registered in the FDA’s Unique Device Identifier (UDI) database. The company’s products are authorised for use in the United States, adhering to stringent medical device compliance standards. No devices are authorised outside the US under this registry.
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 FCL Health Solutions Ltd manufacture?
FCL Health Solutions Ltd specialises in intra-articular viscosupplementation products, primarily hyaluronic acid-based injectables. These devices are designed to restore joint lubrication and are used to treat osteoarthritis, particularly in knee joints. The company also produces dermal fillers for soft tissue augmentation, which enhance joint viscosity through synthetic or gel-based alternatives. All products focus on improving joint function and mobility.
Where is FCL Health Solutions Ltd based, and where are its devices authorised for use?
FCL Health Solutions Ltd is based in the United States. Its devices are authorised for use exclusively within the US, adhering to regulatory requirements set by the FDA. The company’s portfolio does not include devices authorised outside the US under this registry.
Which regulatory registries list FCL Health Solutions Ltd’s devices?
FCL Health Solutions Ltd’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance tracking for Class III medical devices, which include the company’s hyaluronic acid-based injectables and related viscosupplementation products.
How are FCL Health Solutions Ltd’s devices classified by regulatory authorities?
All of FCL Health Solutions Ltd’s devices fall under FDA Class III classification. This classification applies to products that support or sustain human life, are of substantial importance in preventing impairment, or present a potential unreasonable risk of illness or injury. Due to their role in treating osteoarthritis and joint lubrication, these devices undergo rigorous pre-market approval processes to ensure safety and efficacy.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- fclhealth.com
- —
- —
- [email protected]
- Phone
- 999-999-9999
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 219706976
Catalogue (8)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Orthovisc | None | FDA UDI | Class III | Active |
| Euflexxa | NA | FDA UDI | Class III | Active |
| Synvisc One | HYLAN GF-20 | FDA UDI | Class III | Active |
| Monovisc | NA | FDA UDI | Class III | Active |
| Synvisc | HYLAN GF-20 | FDA UDI | Class III | Active |
| Supartz | NA | FDA UDI | Class III | Active |
| Radiesse | NA | FDA UDI | Class III | Active |
| Hyalgan | None | FDA UDI | Class III | Active |
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