FDA Registration
Active
🇯🇵 Japan
HITACHI HIGH-TECH CORP., NAKA DIVISION
Reg #: 9614673
·
FEI: 3003559576
·
Expires 2026
Products
13
Proprietary Names
42
Establishment Types
1
Classifications
13
Registration Details
- Registration Name
- HITACHI HIGH-TECH CORP., NAKA DIVISION
- Registration Number
- 9614673
- FEI Number
- 3003559576
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 882 ICHIGE
- City
- Hitachinaka-shi Ibaraki
- Country
- JP
Owner / Operator
- Firm Name
- HITACHI HIGH-TECH CORP.
- Operator Number
- 9049564
- Address
- 1-17-1 Toranomon,, --
- City
- Minato-ku
- State
- Tokyo
- Postal Code
- 105-6409
- Country
- JP
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hexokinase, Glucose | CFR | Class 2 | Clinical Chemistry | No | 2019-08-19 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2019-08-19 |
| Radioimmunoassay, Thyroid-Stimulating Hormone | JLW | Class 2 | Clinical Chemistry | No | 2019-08-19 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2019-08-19 |
| Columns, Liquid Chromatography | DPM | Class 1 | Clinical Chemistry | No | 2025-07-02 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2022-09-25 |
| Calculator/Data Processing Module, For Clinical Use | JQP | Class 1 | Clinical Chemistry | No | 2014-11-24 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2013-03-11 |
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2013-03-11 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2014-11-27 |
| Dna Genetic Analyzer | PCA | Class 2 | Clinical Chemistry | No | 2013-03-13 |
| Hemoglobin A1c Test System | PDJ | Class 2 | Clinical Chemistry | No | 2017-01-16 |
| Mass Spectrometer, Clinical Use | DOP | Class 1 | Clinical Chemistry | No | 2025-07-02 |
Proprietary Names
cobas pro integrated solutions
Ionify iRapidC cobas i
Ionify iHPLC cobas i
Ionify iRapidB cobas i
cobas pure integrated solutions
CCM Vertical Elevator Unit
CCM Vertical Overhead Conveyor Unit (1m)
Modular Pre-Analytics
cobas 8100 automated workflow series
CONVEYOR 3 Unit
Modular Connection Unit
Linear Buffer Unit
OUTPUT UNIT
Cobas 6000 Connection Unit
Add-On Buffer Unit
CCM Backend Connection Unit
CCM Vertical Turntable Unit
Cobas 8000 Connection Unit
CCM Vertical Power Box Unit
CONVEYOR 1 Unit
CCM Address Extension Unit
Power Supply Unit
CONVEYOR 2 Unit
CCM Bidirectional Interface
Turn Unit
HST Connection Unit
CCM cobas c513 Connection Unit
CONVEYOR 4 Unit
c311
cobas 6000 Series System (c501 and e601 Module)
Clinical Laboratory Automation System (CLAS)
Dummy HPLC Cartridge
Dummy Rapid Cartridge
cobas e 801 immunoassay Analyzer
ELECSYS 2010 ANALYZER
e411
MODULAR E
cobas c 513 Analyzer
cobas i 601
cobas i 601 SBL
cobas pro i 601 BL
cobas 8000 Modular Analyzer Series (c502, c701, c702, e602 and ISE Module)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)