FDA Registration
Active
🇯🇵 Japan
NIDEK CO., LTD.
Reg #: 8030392
·
FEI: 3002807715
·
Expires 2025
Products
8
Proprietary Names
0
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- NIDEK CO., LTD.
- Registration Number
- 8030392
- FEI Number
- 3002807715
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 34-14 MAEHAMA, HIROISHI-CHO
- City
- GAMAGORI, AICHI
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K181345
Owner / Operator
- Firm Name
- NIDEK CO., LTD.
- Operator Number
- 8030392
- Address
- 34-14 MAEHAMA, HIROISHI-CHO, --
- City
- GAMAGORI, AICHI
- State
- JP-23
- Postal Code
- 4430038
- Country
- JP
- Correspondent
- Takashi - Matsuura
US Agent
- Business Name
- NIDEK INCORPORATED
- Contact Name
- Koji Torii
- Address
- 6601 Cascades Court, Suite 130
- City
- The Colony
- State
- TX
- ZIP
- 75056
- Country
- US
- [email protected]
- Phone
- 800 2239044
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Biomicroscope, Slit-Lamp, Ac-Powered | HJO | Class 2 | Ophthalmic | No | 2018-07-20 |
| Microscope, Specular | NQE | Class 2 | Ophthalmic | No | 2018-07-20 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2018-07-20 |
| Device, Storage, Images, Ophthalmic | NFF | Class 1 | Radiology | No | 2018-07-20 |
| System, Image Management, Ophthalmic | NFJ | Class 2 | Radiology | No | 2018-07-20 |
| Device, Communications, Images, Ophthalmic | NFG | Class 1 | Radiology | No | 2018-07-20 |
| Tomography, Optical Coherence | OBO | Class 2 | Ophthalmic | No | 2018-07-20 |
| Camera, Ophthalmic, Ac-Powered | HKI | Class 2 | Ophthalmic | No | 2018-07-20 |
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility