FDA Registration
Active
🇮🇪 Ireland
ReFeel
Reg #: 3019147058
·
FEI: 3019147058
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- PBC BIOMED
- Registration Number
- 3019147058
- FEI Number
- 3019147058
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Unit 4D Western Business Park
- City
- Shannon Clare
- Country
- IE
Regulatory Submissions
- 510(k) Number
- K233322
Owner / Operator
- Firm Name
- PBC BioMed
- Operator Number
- 10091349
- Address
- Unit 4D Western Business Park
- City
- Shannon
- State
- Clare
- Postal Code
- V14RW92
- Country
- IE
- Correspondent
- Vijay Vadhiraj
US Agent
- Business Name
- PBC Biomed
- Contact Name
- Thomas A. Russell
- Address
- 10300 Twin Bridges Cv
- City
- Eads
- State
- TN
- ZIP
- 38028
- Country
- US
- [email protected]
- Phone
- 901 4139870
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cuff, Nerve | JXI | Class 2 | Neurology | No | 2024-09-02 |
Proprietary Names
ReFeel
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)