FDA Registration
Active
🇯🇵 Japan
Sysmex RA Co., LTD, Main Office
Reg #: 3010188766
·
FEI: 3010188766
·
Expires 2026
Products
5
Proprietary Names
49
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Sysmex RA Co., LTD, Main Office
- Registration Number
- 3010188766
- FEI Number
- 3010188766
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3034 Hirooka-Nomura
- City
- Shiojiri Nagano
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K031377
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 |
|---|---|---|---|---|---|
| Instrument, Coagulation, Automated | GKP | Class 2 | Hematology | No | 2012-02-20 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2011-07-06 |
| Timer, General Laboratory | JBS | Class 1 | Clinical Chemistry | No | 2017-01-22 |
| Slide Stainer, Automated | KPA | Class 1 | Pathology | No | 2012-03-18 |
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | Class 1 | Clinical Chemistry | No | 2016-12-01 |
Proprietary Names
CA-620
CA-660
Option Sampler SA-90
XS-1000i sampler (OPSU-11)
HST-N
SA-31
Barcode Terminal (BT-40)
ST-40
SA-30
AlphaN-SPSU
CV-65
RB-10
Pneumatic Unit (PU-17)
SA-02
RU-10
ST-42
SA-10
SA-20
SA-21
ST-41
CV-60
SA-01
CF-70
CV-50
RR-20
RR-10 COMPLETE
OPSU-6
CV-55
AlphaN-XESU
RU-21
TS-10
RU-20
CV-70
TU-40
CF-60
SA-51
U-RDU
CV-11
TH-11
BT-50
TS-01 Automated Tube Sorter
TA-01 Automated Tube Archiver
Urine Sample Transportation Unit ST-10
Urine Sample Transportation Unit ST-11
Urine Sample Transportation Unit ST-12
AUW TRACK
SP-50
SP-1000i
SP-10
Establishment Types
Manufacture Medical Device