FDA Registration
Active
🇯🇵 Japan
CELLCLEAN AUTO
Reg #: 3002759288
·
FEI: 3002759288
·
Expires 2025
Products
1
Proprietary Names
10
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SYSMEX CORPORATION KAKOGAWA FACTORY
- Registration Number
- 3002759288
- FEI Number
- 3002759288
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 314-2 Kitano, Noguchi-cho
- 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 |
|---|---|---|---|---|---|
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 1998-05-06 |
Proprietary Names
CELLCLEAN AUTO
CELLCLEAN
CA CLEAN I
Concentrated phosphate buffer for SP pH 6.8
Concentrated phosphate buffer for SP pH 7
Concentrated phosphate buffer for SP pH 6.6
Concentrated phosphate buffer for SP pH 7.2
XW CELLCLEAN
CyFlow CLEAN
CA CLEAN II
Establishment Types
Export Device to the United States But Perform No Other Operation on Device