FDA Registration
Active
🇦🇺 Australia
BP+
Reg #: 3004987887
·
FEI: 3004987887
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- USCOM LIMITED
- Registration Number
- 3004987887
- FEI Number
- 3004987887
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- LEVEL 8, 66 CLARENCE STREET
- City
- SYDNEY New South Wales
- Country
- AU
Regulatory Submissions
- 510(k) Number
- K121266
Owner / Operator
- Firm Name
- USCOM LIMITED
- Operator Number
- 9068236
- Address
- LEVEL 8, 66 CLARENCE STREET, --
- City
- SYDNEY, NSW
- State
- New South Wales
- Postal Code
- 2000
- Country
- AU
- Correspondent
- NICK - SCHICHT
US Agent
- Business Name
- ProMedic, LLC
- Contact Name
- Matt Dryden
- Address
- 131 Bay Point Dr NE
- City
- Saint Petersburg
- State
- FL
- ZIP
- 33704
- Country
- US
- [email protected]
- Phone
- 239 3076063
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2013-07-22 |
Proprietary Names
BP+
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device