FDA Registration
Active
🇦🇺 Australia
SOZO Pro
Reg #: 3004782476
·
FEI: 3004782476
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Impedimed Limited
- Registration Number
- 3004782476
- FEI Number
- 3004782476
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Unit 1, 50 Parker Court, Pinkenba
- City
- Brisbane Queensland
- Country
- AU
Regulatory Submissions
- 510(k) Number
- K232089
Owner / Operator
- Firm Name
- Impedimed Limited
- Operator Number
- 10023581
- Address
- Unit 1, 50 Parker Court, Pinkenba
- City
- Brisbane
- State
- Queensland
- Postal Code
- 4008
- Country
- AU
US Agent
- Business Name
- ImpediMed Ltd.
- Contact Name
- Richard Hines
- Address
- 5900 Pasteur Ct., Suite 125
- City
- Carlsbad
- State
- CA
- ZIP
- 92008
- Country
- US
- [email protected]
- Phone
- 760 5852104
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plethysmograph, Impedance | DSB | Class 2 | Cardiovascular | No | 2025-05-13 |
Proprietary Names
SOZO Pro
Establishment Types
Manufacture Medical Device