FDA Registration
Active
🇦🇺 Australia
Reflect
Reg #: 3024040179
·
FEI: 3024040179
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- AKUNAH
- Registration Number
- 3024040179
- FEI Number
- 3024040179
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Suite 307, Level 9, Nicholson St Specialist Centre, 121 Newdegate Street, Greenslopes, QLD
- City
- Brisbane Queensland
- Country
- AU
Regulatory Submissions
- 510(k) Number
- K222987
Owner / Operator
- Firm Name
- Akunah
- Operator Number
- 10091538
- Address
- Suite 307, Level 9, Nicholson St Specialist Centre, 121 Newdegate Street, Greenslopes, QLD
- City
- Brisbane
- State
- Queensland
- Postal Code
- 4120
- Country
- AU
- Correspondent
- Shanthan Pather
US Agent
- Business Name
- Pearl Pathways
- Contact Name
- Ariana Jones
- Address
- 29 E Mccarty St Ste 100
- City
- Indianapolis
- State
- IN
- ZIP
- 46225
- Country
- US
- [email protected]
- Phone
- 317 8999341
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2024-12-02 |
Proprietary Names
Reflect
Establishment Types
Manufacture Medical Device