FDA Registration
Active
🇯🇵 Japan
Menicon Co., Ltd., R&D Center
Reg #: 3003062331
·
FEI: 3003062331
·
Expires 2026
Products
8
Proprietary Names
12
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- Menicon Co., Ltd., R&D Center
- Registration Number
- 3003062331
- FEI Number
- 3003062331
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5-1-10, Takamoridai
- City
- Kasugai Aichi
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K180004
- PMA Number
- P990018
Owner / Operator
- Firm Name
- MENICON CO. LTD.
- Operator Number
- 9001029
- Address
- 21-19 AOI, 3-CHOME, NAKA-KU, --
- City
- NAGOYA
- State
- Aichi
- Postal Code
- 460-0006
- Country
- JP
- Correspondent
- Zhu Jiang
US Agent
- Business Name
- MENICON AMERICA, INC.
- Contact Name
- Alberty Recio
- Address
- 76 TREBLE COVE RD BLDG #3
- City
- N Billerica
- State
- MA
- ZIP
- 01862
- Country
- US
- [email protected]
- Phone
- 781 6092042
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lenses, Soft Contact, Daily Wear | LPL | Class 2 | Ophthalmic | No | 2018-02-23 |
| Case, Contact Lens | LRX | Class 2 | Ophthalmic | No | 2002-08-13 |
| Products, Contact Lens Care, Rigid Gas Permeable | MRC | Class 2 | Ophthalmic | No | 2020-07-21 |
| Lens, Contact (Other Material) - Daily | HQD | Class 2 | Ophthalmic | No | 2007-11-29 |
| Accessories, Soft Lens Products | LPN | Class 2 | Ophthalmic | No | 2021-07-14 |
| Lens, Contact, Orthokeratology, Overnight | NUU | Class 3 | Ophthalmic | No | 2007-11-09 |
| Lens, Contact (Rigid Gas Permeable), Extended Wear | MWL | Class 3 | Ophthalmic | No | 2007-11-09 |
| Lens, Contact, (Disposable) | MVN | Class 2 | Ophthalmic | No | 2020-07-02 |
Proprietary Names
Miru 1month Menicon (1Month SiHy)
Miru 1day Menicon Flat Pack Toric
Miru 1day Menicon Flat Pack
MENICON SP VIAL
Menicon Progent Protein Remover
Menicon Z DW
MeniSept
Menicon Z Irregular Cornea
LacriPure
MENICON Z RIGID GAS PERMEABLE CONTACT LENS
Miru 1day UpSide (1 Day SiHy)
Menicon Z Large Diameter
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility