FDA Registration
Active
🇯🇵 Japan
SHIMADZU CORPORATION ANALYTICAL&MEASURING INSTRUMENTS DIV.
Reg #: 3010607747
·
FEI: 3010607747
·
Expires 2026
Products
3
Proprietary Names
43
Establishment Types
3
Classifications
3
Registration Details
- Registration Name
- SHIMADZU CORPORATION ANALYTICAL&MEASURING INSTRUMENTS DIV.
- Registration Number
- 3010607747
- FEI Number
- 3010607747
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1, NISHINOKYO-KUWABARACHO, NAKAGYO-KU
- City
- KYOTO
- Country
- JP
Owner / Operator
- Firm Name
- Shimadzu Corporation
- Operator Number
- 8030233
- Address
- 1 NISHINOKYO KUWABARA-CHO
- City
- KYOTO-SHI
- State
- JP-26
- Postal Code
- 604-8511
- Country
- JP
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mass Spectrometer, Clinical Use | DOP | Class 1 | Clinical Chemistry | No | 2013-11-29 |
| Apparatus, High Pressure Liquid Chromatography | KIE | Class 1 | Clinical Chemistry | No | 2013-11-26 |
| Reagents, 2019-Novel Coronavirus Nucleic Acid | QJR | Class N | Unknown | No | 2020-09-08 |
Proprietary Names
LCMS-8040 CL
LCMS-8050 CL
LCMS-8060 CL
GCMS-QP2020 CL
LCMS-8045 CL
LCMS-8060NX CL
GCMS-TQ8050 CL
Degassing Unit DGU-20A5R CL
UV-VIS Detector SPD-20A CL
UV-VIS Detector SPD-20AV CL
Degassing Unit DGU-20A3R CL
Column Oven CTO-20AC CL
Nexera CL Liquid Chromatograph LC-20ADXR CL
Nexera CL Liquid Chromatograph LC-30AD CL
Communications Bus Module CBM-20A CL
Communications Bus Module CBM-20Alite CL
Reservoir Switching Valve Kit for LC-30AD CL
Nexera CL Autosampler SIL-20ACXR CL
Valve Unit FCV-20AH2 CL
Prominence CL Liquid Chromatograph LC-20AD CL
Nexera CL Column Oven CTO-30A CL
Nexera CL Diode Array Detector SPD-M30A CL
Nexera CL Autosampler SIL-30ACMP CL
Prominence CL Autosampler SIL-20ACHT CL
Valve Unit FCV-32AH CL
Prominence CL Autosampler SIL-20AC CL
LC-30AD CL Low Volume LPGE KIT
Nexera CL Autosampler SIL-30AC CL
Diode Array Detector SPD-M20A CL
Prominence CL Autosampler SIL-20AHT CL
Valve Unit FCV-36AH CL
SOLVENT DELIVERY MODULE LC-40D X3 CL
SOLVENT DELIVERY MODULE LC-40D XR CL
AUTO SAMPLER SIL-40C X3 CL
COLUMN OVEN CTO-40C CL
SOLVENT DELIVERY MODULE LC-40B X3 CL
DEGASSING UNIT DGU-405 CL
FLOW CHANNEL SELECTION VALVE FCV-S CL
AUTO SAMPLER SIL-40C XR CL
SYSTEM CONTROLLER CBM-40 CL
PLATE CHANGER CL
UV-VIS DETECTOR SPD-40 CL
2019 NOVEL CORONAVIRUS DETECTION KIT
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device