FDA Registration
Active
🇦🇺 Australia
FV-HD Base
Reg #: 3012828634
·
FEI: 3012828634
·
Expires 2025
Products
1
Proprietary Names
8
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- VISIONFLEX PTY LIMITED
- Registration Number
- 3012828634
- FEI Number
- 3012828634
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1/8 Prosperity Parade Warriewood
- City
- Sydney New South Wales
- Country
- AU
Owner / Operator
- Firm Name
- Visionflex Pty Limited
- Operator Number
- 10051656
- Address
- 1/8 Prosperity Parade Warriewood
- City
- Sydney
- State
- New South Wales
- Postal Code
- 2102
- Country
- AU
US Agent
- Business Name
- Brenda J McGivern PC
- Contact Name
- Brenda McGivern
- Address
- 532 Page Street
- City
- Stoughton
- State
- MA
- ZIP
- 02072
- Country
- US
- [email protected]
- Phone
- 781 3410930 ext. 11
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Camera, Cine, Endoscopic, Without Audio | FWL | Class 1 | General, Plastic Surgery | No | 2017-07-26 |
Proprietary Names
FV-HD Base
GEIS - HD General Exam Camera
LED Light Source - USB
Endoscope Camera with Adaptor - SD
Universal FSC2 Camera Handpiece
Intra Oral Camera Lercher
Endoscope Camera Head HD Zoom
FSC3 Multi functional Camera Handpiece
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Export Device to the United States But Perform No Other Operation on Device