FDA Registration
Active
🇺🇸 United States
medipen
Reg #: 3018153007
·
FEI: 3018153007
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- EQUIPMED USA LLC
- Registration Number
- 3018153007
- FEI Number
- 3018153007
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4695 MacArthur Court F11
- City
- Newport Beach
- State
- CA
- ZIP
- 92660
- Country
- US
Regulatory Submissions
- 510(k) Number
- K221070
Owner / Operator
- Firm Name
- Equipmed USA LLC
- Operator Number
- 10082209
- Address
- 4695 MacArthur Court F11
- City
- Newport Beach
- State
- CA
- Postal Code
- 92660
- Country
- US
- Correspondent
- Shaun Kerrigan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powered Microneedle Device | QAI | Class 2 | General, Plastic Surgery | No | 2023-03-22 |
Proprietary Names
medipen
dermapen 4 dp4 medipen
dp4
Establishment Types
Manufacture Medical Device