FDA Registration
Active
🇯🇵 Japan
CC7-402
Reg #: 3006161756
·
FEI: 3002808127
·
Expires 2025
Products
6
Proprietary Names
5
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- FUJIFILM Healthcare Manufacturing Corporation Sano Office
- Registration Number
- 3006161756
- FEI Number
- 3002808127
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 700 Konaka-Cho
- City
- Sano City Tochigi
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K203717
Owner / Operator
- Firm Name
- FUJIFILM CORPORATION
- Operator Number
- 8031568
- Address
- 26-30, Nishiazabu 2-chome
- City
- MINATO-KU
- State
- Tokyo
- Postal Code
- 106-8620
- Country
- JP
US Agent
- Business Name
- FUJIFILM Healthcare Americas Corporation
- Contact Name
- Randy Vader
- Address
- 81 Hartwell Avenue, Suite 300
- City
- Lexington
- State
- MA
- ZIP
- 02421
- Country
- US
- [email protected]
- Phone
- 360 3566821
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter, Tissue Saturation | MUD | Class 2 | Cardiovascular | No | 2021-07-01 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2021-07-01 |
| Led Light Source | NTN | Class 2 | Gastroenterology, Urology | No | 2021-07-01 |
| Endoscope, Accessories, Image Post-Processing For Color Enhancement | PEA | Class 2 | Gastroenterology, Urology | No | 2021-07-01 |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FET | Class 2 | Gastroenterology, Urology | No | 2021-07-01 |
| Endoscope, Accessories, Narrow Band Spectrum | NWB | Class 2 | Gastroenterology, Urology | No | 2021-07-01 |
Proprietary Names
CC7-402
Processor VP-7000
Image Processing Unit EX-0
Light Source BL-7000X
CC7-502
Establishment Types
Manufacture Medical Device