FDA Registration
Active
🇯🇵 Japan
FUJI SYSTEMS CORPORATION, Shirakawa Plant
Reg #: 3000308637
·
FEI: 3000308637
·
Expires 2026
Products
8
Proprietary Names
6
Establishment Types
2
Classifications
8
Registration Details
- Registration Name
- FUJI SYSTEMS CORPORATION, Shirakawa Plant
- Registration Number
- 3000308637
- FEI Number
- 3000308637
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Shirakawa Plant, 200-2 Aza-Ohira, Odakura, Nishigo
- City
- Nishi Shirakawa Gun Fukushima
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K120781
Owner / Operator
- Firm Name
- FUJI SYSTEMS CORPORATION
- Operator Number
- 9052600
- Address
- 23-14, HONGO 3-CHOME, BUNKYO-KU, --
- City
- TOKYO
- State
- JP-13
- Postal Code
- 113-0033
- Country
- JP
US Agent
- Business Name
- Geissinger Regulatory Consulting, Inc.
- Contact Name
- Gregory Geissinger
- Address
- 6 Basilica Pl
- City
- Ladera Ranch
- State
- CA
- ZIP
- 92694
- Country
- US
- [email protected]
- Phone
- 858 3498839
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2012-08-21 |
| Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) | CBI | Class 2 | Anesthesiology | No | 2008-08-26 |
| Endoscope, Accessories, Narrow Band Spectrum | NWB | Class 2 | Gastroenterology, Urology | No | 2008-07-17 |
| Enteroscope And Accessories | FDA | Class 2 | Gastroenterology, Urology | No | 2008-07-17 |
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | Class 2 | Gastroenterology, Urology | No | 2008-07-17 |
| Catheter, Percutaneous, Neurovasculature | QJP | Class 2 | Cardiovascular | No | 2023-11-05 |
| Tube, Tracheal (W/Wo Connector) | BTR | Class 2 | Anesthesiology | No | 2008-08-26 |
| Catheter, Retention Type, Balloon | EZL | Class 2 | Gastroenterology, Urology | No | 2007-11-01 |
Proprietary Names
CELLO Balloon Guide Catheter; 6F, 7F, 8F, 9F
Univent Tube 7mm, 7.5mm, 8mm, 8.5mm, 9mm
Silbroncho Double Lumen Tube
Pediatric Cuffed And Uncuffed Et Tube; Standard Cuffed and Uncuffed Et Tube
Wire Reinforced Endotracheal Tube
Phycon All Silicone Balloon Catheter
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)