FDA Registration
Active
🇯🇵 Japan
FUJIFILM Healthcare Manufacturing Corporation Minamiashigara Takematsu Office
Reg #: 2155
·
FEI: 2155
·
Expires 2026
Products
8
Proprietary Names
15
Establishment Types
2
Classifications
8
Registration Details
- Registration Name
- FUJIFILM Healthcare Manufacturing Corporation Minamiashigara Takematsu Office
- Registration Number
- 2155
- FEI Number
- 2155
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1250 TAKEMATSU
- City
- MINAMIASHIGARA-SHI Kanagawa
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K042023
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 Ave Ste 100
- City
- Lexington
- State
- MA
- ZIP
- 02421
- Country
- US
- [email protected]
- Phone
- 360 3566821
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | Class 2 | Radiology | No | 2008-03-11 |
| Micro Total Analysis Instrument System | OUE | Class 2 | Clinical Chemistry | No | 2014-01-31 |
| Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma | OAU | Class 2 | Immunology | No | 2014-01-31 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2014-01-31 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2014-01-31 |
| Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment | NSF | Class 2 | Immunology | No | 2014-01-31 |
| Accelerator, Linear, Medical | IYE | Class 2 | Radiology | No | 2013-01-30 |
| Screen, Intensifying, Radiographic | EAM | Class 1 | Radiology | No | 2007-04-04 |
Proprietary Names
FCR CARBON XL-2 (CR-IR359)
FCR XL-2 (CR-IR359)
Fuji IP Cassette Type CC
FCR Prima T2 (CR-IR392)
FCR PRIMA Tm(CR-IR392)
FCR CARBON (CR-IR357)
FCR Prima T2(CR-IR392)
FCR XC-2 (CR-IR357)
FCR Prima T(CR-IR392)
uTASWako DCP
uTASWako AFP-L3
Fuji IP Cassette Type PC
Fuji IP Cassette Type CH
Fuji IP Cassette Type LC
FUJI IMAGING PLATE ST-VI
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)