FDA Registration
Active
🇯🇵 Japan
Ophtecs Manufacturing Ltd.
Reg #: 3038161965
·
FEI: 3038161965
·
Expires 2026
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
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Registration Details
- Registration Name
- Ophtecs Manufacturing Ltd.
- Registration Number
- 3038161965
- FEI Number
- 3038161965
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 26 Kamiyoshidai
- City
- Toyooka Hyogo
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K251876
Owner / Operator
- Firm Name
- Ophtecs Manufacturing Ltd.
- Operator Number
- 10094487
- Address
- 26 Kamiyoshidai
- City
- Toyooka
- State
- Hyogo
- Postal Code
- 668-0831
- Country
- JP
- Correspondent
- Haruki Nakagawa
US Agent
- Business Name
- EYEREG CONSULTING INC.
- Contact Name
- Bret Andre
- Address
- 3762 Landis St
- City
- West Linn
- State
- OR
- ZIP
- 97068
- Country
- US
- [email protected]
- Phone
- 503 3725226
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Products, Contact Lens Care, Rigid Gas Permeable | MRC | Class 2 | Ophthalmic | No | 2025-12-03 |
Proprietary Names
cleadew GP hydra one
Establishment Types
Manufacture Medical Device