FDA Registration
Inactive
🇦🇺 Australia
Minder
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- EPIMINDER LIMITED
- Status
- Inactive
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 525 Collins Street, Suite 210
- City
- Melbourne Victoria
- Country
- AU
Regulatory Submissions
- 510(k) Number
- DEN240062
Owner / Operator
- Firm Name
- Epiminder Limited
- Operator Number
- 10093773
- Address
- 525 Collins Street, Suite 210
- City
- Melbourne
- State
- Victoria
- Postal Code
- 3000
- Country
- AU
- Correspondent
- Tracy Cameron
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring | SEM | Class 2 | Neurology | No | 2025-07-08 |
Proprietary Names
Minder
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility