FDA Registration
Active
🇯🇵 Japan
Urinalysis Data Manager (UDM)
Reg #: 3010960914
·
FEI: 3010960914
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SYSMEX CORPORATION i-SQUARE
- Registration Number
- 3010960914
- FEI Number
- 3010960914
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 262-11 Mizuashi, Noguchicho
- City
- Kakogawa 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 |
|---|---|---|---|---|---|
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2011-12-30 |
Proprietary Names
Urinalysis Data Manager (UDM)
Sysmex WAM (Work Area Management)
Establishment Types
Manufacture Medical Device