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Sign in to claim this brandCONTAMAC HOLDINGS LIMITED
US
Last updated May 25, 2026
What CONTAMAC HOLDINGS LIMITED makes
The company manufactures rigid-gas-permeable contact lenses designed for daily wear, including variants such as single-vision and multifocal designs. These lenses include specific models like the Optimum HR 1.53, Hybird FS, and Optimum Extra, each tailored for different vision correction needs.
All listed devices fall under FDA Class II regulation and are included 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 Contamac Holdings Limited manufacture?
Contamac Holdings Limited specializes in rigid-gas-permeable corrective contact lenses designed for daily wear. These lenses are intended for vision correction and include models like single-vision and multifocal designs, such as the Optimum HR 1.53, Hybird FS, and Optimum Extra. The focus is on providing durable, oxygen-permeable solutions for extended comfort and clarity.
Where is Contamac Holdings Limited based?
The company is headquartered in the United States. This location aligns with regulatory frameworks like the FDA, which governs the classification and listing of its devices in the U.S. market.
Which regulatory registries list Contamac Holdings Limited’s devices?
Contamac Holdings Limited’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for Class II devices, which include their rigid-gas-permeable contact lenses. The UDI system helps track and monitor these products throughout their lifecycle.
How are Contamac Holdings Limited’s devices classified under U.S. regulations?
All of Contamac Holdings Limited’s listed devices fall under FDA Class II classification. This category applies to products that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, such as rigid-gas-permeable contact lenses, which require precise manufacturing and material standards.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 216236887
Catalogue (9)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Optimum HR 1.53 | hirafocon B | FDA UDI | Class II | Active |
| Hybird FS | hybufocon A | FDA UDI | Class II | Active |
| Optimum HR 1.51 | hirafocon A | FDA UDI | Class II | Active |
| Optimum Extra | roflufocon D | FDA UDI | Class II | Active |
| Optimum Comfort | roflufocon C | FDA UDI | Class II | Active |
| Optimum Extreme | roflufocon E | FDA UDI | Class II | Active |
| Hexa100 | hexafocon A | FDA UDI | Class II | Active |
| Optimum Classic | roflufocon A | FDA UDI | Class II | Active |
| Optimum Infinite | Tisilfocon A | FDA UDI | Class II | Active |
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