FDA Registration
Active
🇯🇵 Japan
FUJIFILM Video Laparoscope Model EL-R740M30
Reg #: 3001722928
·
FEI: 3001722928
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- FUJIFILM CORPORATION
- Registration Number
- 3001722928
- FEI Number
- 3001722928
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 798 MIYANODAI KAISEI-MACHI
- City
- ASHIGARAKAMI-GUN Kanagawa
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K212950
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 |
|---|---|---|---|---|---|
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2021-12-06 |
Proprietary Names
FUJIFILM Video Laparoscope Model EL-R740M30
Establishment Types
Manufacture Medical Device