FDA Registration
Active
🇦🇺 Australia
Patient Administration Set
Reg #: 8043631
·
FEI: 3009638066
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CYCLOMEDICA AUSTRALIA PTY LTD
- Registration Number
- 8043631
- FEI Number
- 3009638066
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Unit 4, 1 The Crescent
- City
- Kingsgrove New South Wales
- Country
- AU
Regulatory Submissions
- 510(k) Number
- K200916
Owner / Operator
- Firm Name
- CYCLOMEDICA AUSTRALIA PTY LTD
- Operator Number
- 9002789
- Address
- Unit 4, 1 The Crescent
- City
- Kingsgrove
- State
- New South Wales
- Postal Code
- 2208
- Country
- AU
US Agent
- Business Name
- EVERSANA Life Science Services LLC
- Contact Name
- Kelly Connor
- Address
- 319 E Jenkins Ave.
- City
- Columbus
- State
- OH
- ZIP
- 43207
- Country
- US
- [email protected]
- Phone
- 614 5929652
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Rebreathing, Radionuclide | IYT | Class 2 | Radiology | No | 2022-10-31 |
Proprietary Names
Patient Administration Set
Establishment Types
Manufacture Medical Device