FDA Registration
Active
🇯🇵 Japan
RM-8900
Reg #: 3008729548
·
FEI: 3008729548
·
Expires 2025
Products
1
Proprietary Names
11
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Topcon Yamagata Co., LTD
- Registration Number
- 3008729548
- FEI Number
- 3008729548
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 547 aza Ishida Oaza Urushiyama Yamagata-SHI
- City
- Yamagata-KEN
- Country
- JP
Owner / Operator
- Firm Name
- Topcon Healthcare, Inc.
- Operator Number
- 9031569
- Address
- 111 Bauer Drive
- City
- Oakland
- State
- NJ
- Postal Code
- 07436
- Country
- US
US Agent
- Business Name
- Topcon Healthcare, Inc.
- Contact Name
- Susan Quick
- Address
- 111 Bauer Drive
- City
- Oakland
- State
- NJ
- ZIP
- 07436
- Country
- US
- [email protected]
- Phone
- 216 7805532
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Refractometer, Ophthalmic | HKO | Class 1 | Ophthalmic | No | 2003-10-06 |
Proprietary Names
RM-8900
KR-1W
KR-800S
KR-800A
RM-800
KR-8000PA
KR-800PA
KR-8900
KR-1
Chronos
KR-800
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)