FDA Registration
Active
🇯🇵 Japan
Poly-Chem
Reg #: 3004438098
·
FEI: 3004438098
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- FURUNO ELECTRIC CO., LTD.
- Registration Number
- 3004438098
- FEI Number
- 3004438098
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2-20, Nishinomiyahama
- City
- NISHINOMIYA-CITY Hyogo
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K020852
Owner / Operator
- Firm Name
- Furuno Electric Co., Ltd.
- Operator Number
- 9048176
- Address
- 9-52 Ashihara-Cho
- City
- Nishinomiya-City
- State
- Hyogo
- Postal Code
- 662-8580
- Country
- JP
US Agent
- Business Name
- Furuno U.S.A., Inc.
- Contact Name
- Bradley Reents
- Address
- 4400 N.W. Pacific Rim Boulevard
- City
- Camas
- State
- WA
- ZIP
- 98607
- Country
- US
- [email protected]
- Phone
- 360 8349300
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hexokinase, Glucose | CFR | Class 2 | Clinical Chemistry | No | 2012-04-10 |
Proprietary Names
Poly-Chem
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device