FDA Registration
Active
🇯🇵 Japan
UF-CONTROL
Reg #: 3007701696
·
FEI: 3007701696
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SYSMEX CORPORATION SEISHIN FACTORY
- Registration Number
- 3007701696
- FEI Number
- 3007701696
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4-3-2 Takatsukadai, Nishi-ku
- City
- Kobe Hyogo
- Country
- JP
Owner / Operator
- Firm Name
- SYSMEX CORPORATION
- Operator Number
- 9014170
- Address
- 4-4-4 TAKATSUKADAI, NISHI-KU
- City
- KOBE
- State
- JP-NOTA
- Postal Code
- 651-2271
- Country
- JP
US Agent
- Business Name
- SYSMEX AMERICA, INC
- Contact Name
- Simon C. Shorter
- Address
- 577 APTAKISIC RD
- City
- Lincolnshire
- State
- IL
- ZIP
- 60069
- Country
- US
- [email protected]
- Phone
- 408 8380220
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Urinalysis Controls (Assayed And Unassayed) | JJW | Class 1 | Clinical Chemistry | No | 2018-05-04 |
Proprietary Names
UF-CONTROL
UF II CONTROL
UF II CALIBRATOR
Establishment Types
Manufacture Medical Device