FDA Registration
Active
🇺🇸 United States
Biotronix Healthcare 1cc, 3cc, 5cc, 10cc, 20cc, 50cc, 30cc,60cc, luer slips and luer lock, with and without needle
Reg #: 3010131137
·
FEI: 3010131137
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BIOTRONIX HEALTHCARE INDUSTRIES INC.
- Registration Number
- 3010131137
- FEI Number
- 3010131137
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 4700 Millenia Blvd Ste 500
- City
- Orlando
- State
- FL
- ZIP
- 32839
- Country
- US
Regulatory Submissions
- 510(k) Number
- K060211
Owner / Operator
- Firm Name
- Biotronix Healthcare Industries Inc.
- Operator Number
- 10043487
- Address
- 4700 Millenia Blvd Suite 500
- City
- Orlando
- State
- FL
- Postal Code
- 32839
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2015-12-16 |
Proprietary Names
Biotronix Healthcare 1cc, 3cc, 5cc, 10cc, 20cc, 50cc, 30cc,60cc, luer slips and luer lock, with and without needle
Norvich Health 1cc, 3cc, 5cc, 10cc, 20cc, 30cc, 50cc, 60cc luer slip and luer lock with and without needle
Establishment Types
Repack or Relabel Medical Device