FDA Registration
Active
🇯🇵 Japan
HST Connection Unit
Reg #: 9610865
·
FEI: 3002806350
·
Expires 2025
Products
1
Proprietary Names
17
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- HITACHI HIGH-TECH CORP., Ome Works
- Registration Number
- 9610865
- FEI Number
- 3002806350
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3-7-19, Imai
- City
- Ome-Shi Tokyo
- Country
- JP
Owner / Operator
- Firm Name
- Hitachi, Ltd.
- Operator Number
- 8030222
- Address
- 1-17-1, Toranomon
- City
- Minato-ku
- State
- Tokyo
- Postal Code
- 105-6412
- Country
- JP
- Correspondent
- Yuko Tamura
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Calculator/Data Processing Module, For Clinical Use | JQP | Class 1 | Clinical Chemistry | No | 2021-04-27 |
Proprietary Names
HST Connection Unit
Modular Connection Unit
CCM Backend Connection Unit
CCM Address Extension Unit
CCM cobas c513 Connection Unit
CONVEYOR 1 Unit
CCM Bidirectional Interface
Linear Buffer Unit
Power Supply Unit
CONVEYOR 4 Unit
OUTPUT UNIT
CONVEYOR 3 Unit
Add-On Buffer Unit
Turn Unit
Cobas 6000 Connection Unit
CONVEYOR 2 Unit
Cobas 8000 Connection Unit
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)