FDA Registration
Active
🇩🇪 Germany
FUJIFILM medwork GmbH
Reg #: 3020707080
·
FEI: 3020707080
·
Expires 2026
Products
3
Proprietary Names
4
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- FUJIFILM medwork GmbH
- Registration Number
- 3020707080
- FEI Number
- 3020707080
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Medworkring 1
- City
- Hochstadt/Aisch Bavaria
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K210625
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 |
|---|---|---|---|---|---|
| Colonoscope And Accessories, Flexible/Rigid | FDF | Class 2 | Gastroenterology, Urology | No | 2021-10-19 |
| Endoscope Channel Accessory | ODC | Class 2 | Gastroenterology, Urology | No | 2021-10-19 |
| Adaptor, Catheter | GCE | Class 1 | General, Plastic Surgery | No | 2026-03-02 |
Proprietary Names
VAL1-G7-50
VAL1-G7-5-50
VAL1-G7-4-50-1
Application Catheter
Establishment Types
Manufacture Medical Device