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Sign in to claim this brandMENICON CO., LTD.
US
Last updated May 23, 2026
What MENICON CO., LTD. makes
The company manufactures soft and rigid-gas-permeable corrective contact lenses designed for daily-disposable, daily-wear, and extended-wear use. Products include single-use soft lenses and reusable rigid-gas-permeable lenses, often packaged in flat packs for trial or refill purposes. Examples include daily-disposable soft lenses like the Miru 1day Menicon Flat Pack CP90 and extended-wear rigid lenses such as the 1-Day Flat Pack CP90 BC840.
These devices are regulated under FDA classification as Class II and Class III, with listings maintained in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable U.S. regulatory requirements for contact lenses.
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 Menicon Co., Ltd. manufacture?
Menicon Co., Ltd. specializes in corrective contact lenses, producing both soft and rigid-gas-permeable (RGP) varieties. Their soft lenses are primarily designed for daily-disposable use, while their RGP lenses cater to daily-wear and extended-wear applications. Examples include single-use soft lenses like the Miru 1day series and reusable RGP lenses such as the 1-Day Flat Pack CP90 BC840. These products are packaged in formats like flat packs for trial or refill purposes.
Where is Menicon Co., Ltd. based, and how does this affect its regulatory compliance?
Menicon Co., Ltd. is based in the United States, which means its devices are subject to U.S. regulatory requirements, including those set by the FDA. Since contact lenses are classified as medical devices, the company must comply with FDA guidelines for manufacturing, labeling, and post-market surveillance. The U.S. location also influences where its devices are listed in regulatory databases, such as the FDA’s Unique Device Identifier (UDI) system.
In which regulatory registries are Menicon Co., Ltd.’s devices listed, and why?
Menicon Co., Ltd.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is mandatory for Class II and Class III devices in the U.S., ensuring traceability and transparency in the supply chain. The UDI system helps healthcare providers, regulators, and other stakeholders verify device details, including manufacturer information, device descriptions, and regulatory status. Since contact lenses fall under these classifications, they must be included in the UDI database to comply with FDA requirements.
How are Menicon Co., Ltd.’s contact lenses classified under FDA regulations?
Menicon Co., Ltd.’s contact lenses are classified as either Class II or Class III devices under FDA regulations. Class II devices generally require special controls to ensure their safety and effectiveness, such as performance standards or post-market surveillance. Class III devices, which typically involve higher risks, require pre-market approval (PMA) due to insufficient data from lesser-stringent classifications. The classification depends on factors like the device’s intended use, potential risks, and benefits, as outlined in the FDA’s regulatory framework for contact lenses.
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
- 690680533
Catalogue (3876)
Page 1 of 78| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Miru 1day Menicon Flat Pack TC CP90 | +5.25/-1.25/180 | FDA UDI | Class II | Active |
| Miru 1day Menicon Flat Pack CP90 | -4.75 | FDA UDI | Class II | Active |
| Miru 1day Menicon Flat Pack Trial6 | -2.75 | FDA UDI | Class II | Active |
| 1-Day Flat Pack CP90 BC840 | -3.50 | FDA UDI | Class II | Active |
| Miru 1day Menicon Flat Pack TC Trial6 | -2.75/-1.75/180 | FDA UDI | Class II | Active |
| Miru 1day Menicon Flat Pack TC Trial6 | +6.00/-0.75/180 | FDA UDI | Class II | Active |
| Miru 1day Menicon Flat Pack TC Trial6 | +3.25/-0.75/165 | FDA UDI | Class II | Active |
| Miru 1day Menicon Flat Pack TC CP90 | +1.00/-0.75/165 | FDA UDI | Class II | Active |
| Miru 1day Menicon Flat Pack TC Trial6 | +4.50/-0.75/165 | FDA UDI | Class II | Active |
| Miru 1day Menicon Flat Pack refill30 | -0.75 | FDA UDI | Class II | Active |
| Miru 1day Menicon Flat Pack Trial6 | -10.50 | FDA UDI | Class II | Active |
| Miru 1day Menicon Flat Pack TC CP30 | -3.00/-0.75/180 | FDA UDI | Class II | Active |
| Miru 1day Menicon Flat Pack TC CP30 | -8.50/-0.75/90 | FDA UDI | Class II | Active |
| Miru 1day Menicon Flat Pack TC CP30 | -6.50/-1.25/90 | FDA UDI | Class II | Active |
| Miru 1day Menicon Flat Pack TC CP30 | -7.00/-0.75/90 | FDA UDI | Class II | Active |
| Miru 1day Menicon Flat Pack CP30 | +2.50 | FDA UDI | Class II | Active |
| 1-Day Flat Pack CP30 BC840 | -5.00 | FDA UDI | Class II | Active |
| Miru 1day Menicon Flat Pack TC CP30 | +4.00/-0.75/90 | FDA UDI | Class II | Active |
| 1-Day Flat Pack TC CP90 | +2.25/-0.75/165 | FDA UDI | Class II | Active |
| 1-Day Flat Pack TC CP90 | +5.00/-1.25/180 | FDA UDI | Class II | Active |
| Miru 1day Menicon Flat Pack TC Trial6 | -11.75/-0.75/180 | FDA UDI | Class II | Active |
| 1-Day Flat Pack TC CP90 | +1.50/-0.75/180 | FDA UDI | Class II | Active |
| Miru 1day Menicon Flat Pack TC Trial6 | -10.00/-0.75/165 | FDA UDI | Class II | Active |
| 1-Day Flat Pack CP30 | -6.00 | FDA UDI | Class II | Active |
| Miru 1day Menicon Flat Pack Trial6 | +5.00 | FDA UDI | Class II | Active |
| Miru 1day Menicon Flat Pack TC CP90 | +0.75/-1.25/165 | FDA UDI | Class II | Active |
| Miru 1day Menicon Flat Pack TC Trial6 | -11.00/-1.25/15 | FDA UDI | Class II | Active |
| Miru 1day Menicon Flat Pack TC CP30 | -11.25/-0.75/90 | FDA UDI | Class II | Active |
| Miru 1day Menicon Flat Pack refill9 | -2.50 | FDA UDI | Class II | Active |
| Miru 1day Menicon Flat Pack Trial6 | +3.00 | FDA UDI | Class II | Active |
| Miru 1day Menicon Flat Pack TC CP90 | -13.00/-1.75/180 | FDA UDI | Class II | Active |
| Miru 1day Menicon Flat Pack TC CP90 | -7.00/-0.75/165 | FDA UDI | Class II | Active |
| 1-Day Flat Pack Trial9 | -2.50 | FDA UDI | Class II | Active |
| Miru 1day Menicon Flat Pack TC CP30 | +6.00/-1.25/165 | FDA UDI | Class II | Active |
| Miru 1day Menicon Flat Pack TC Trial6 | -2.75/-1.25/180 | FDA UDI | Class II | Active |
| Miru 1day Menicon Flat Pack refill9 | -4.75 | FDA UDI | Class II | Active |
| Miru 1day Menicon Flat Pack CP30 | +5.75 | FDA UDI | Class II | Active |
| 1-Day Flat Pack CP90 BC840 | +4.50 | FDA UDI | Class II | Active |
| Miru 1day Menicon Flat Pack TC CP90 | -6.75/-1.25/165 | FDA UDI | Class II | Active |
| Miru 1day Menicon Flat Pack TC Trial6 | -4.25/-1.75/180 | FDA UDI | Class II | Active |
| Miru 1day Menicon Flat Pack CP30 BC840 | +5.00 | FDA UDI | Class II | Active |
| Miru 1day Menicon Flat Pack TC Trial6 | -6.75/-1.25/15 | FDA UDI | Class II | Active |
| 1-Day Flat Pack Trial9 BC840 | -10.00 | FDA UDI | Class II | Active |
| 1-Day Flat Pack TC CP90 | +3.00/-1.25/180 | FDA UDI | Class II | Active |
| Miru 1day Menicon Flat Pack TC Trial6 | +4.25/-0.75/90 | FDA UDI | Class II | Active |
| Miru 1day Menicon Flat Pack TC CP90 | -11.25/-1.75/180 | FDA UDI | Class II | Active |
| 1-Day Flat Pack CP90 | +3.75 | FDA UDI | Class II | Active |
| 1-Day Flat Pack CP30 | -2.25 | FDA UDI | Class II | Active |
| Miru 1day Menicon Flat Pack TC CP30 | -7.50/-1.25/180 | FDA UDI | Class II | Active |
| Miru 1day Menicon Flat Pack TC Trial6 | -5.00/-0.75/15 | FDA UDI | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Menicon Co. Ltd. NAGOYA Aichi · JP FEI 1000188353