FDA Registration
Active
🇦🇺 Australia
Ovira
Reg #: 3016442124
·
FEI: 3016442124
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- OVIRA PTY LTD
- Registration Number
- 3016442124
- FEI Number
- 3016442124
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 23 Twisden Road
- City
- Bentleigh Victoria
- Country
- AU
Regulatory Submissions
- 510(k) Number
- K140168
Owner / Operator
- Firm Name
- Ovira Pty Ltd
- Operator Number
- 10062427
- Address
- 23 Twisden Road
- City
- Bentleigh
- State
- Victoria
- Postal Code
- 3204
- Country
- AU
- Correspondent
- Alice J Williams
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2020-01-24 |
Proprietary Names
Ovira
Noha
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Export Device to the United States But Perform No Other Operation on Device
Foreign Private Label Distributor