FDA Registration
Active
🇳🇱 Netherlands
Menicon B.V.
Reg #: 3003357577
·
FEI: 3003357577
·
Expires 2026
Products
3
Proprietary Names
4
Establishment Types
1
Classifications
3
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Registration Details
- Registration Name
- Menicon B.V.
- Registration Number
- 3003357577
- FEI Number
- 3003357577
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Waanderweg 6
- City
- Emmen Drenthe
- Country
- NL
Regulatory Submissions
- 510(k) Number
- K180616
- 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 |
|---|---|---|---|---|---|
| Lens, Contact (Other Material) - Daily | HQD | Class 2 | Ophthalmic | No | 2021-08-02 |
| 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 |
Proprietary Names
Menicon Z Large Diameter
MENICON Z RIGID GAS PERMEABLE CONTACT LENS
Menicon Z DW
Menicon Z Irregular Cornea
Establishment Types
Manufacture Medical Device