FDA Registration
Active
🇺🇸 United States
AVITA MEDICAL AMERICAS LLC
Reg #: 3014270795
·
FEI: 3014270795
·
Expires 2026
Products
2
Proprietary Names
3
Establishment Types
2
Classifications
2
Registration Details
- Registration Name
- AVITA MEDICAL AMERICAS LLC
- Registration Number
- 3014270795
- FEI Number
- 3014270795
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 28159 Avenue Stanford, Suite 220
- City
- Valencia
- State
- CA
- ZIP
- 91355
- Country
- US
Regulatory Submissions
- PMA Number
- BP170122
Owner / Operator
- Firm Name
- Avita Medical Americas LLC
- Operator Number
- 10058722
- Address
- 28159 Avenue Stanford, Suite 220
- City
- Valencia
- State
- CA
- Postal Code
- 91355
- Country
- US
- Correspondent
- Ron Lagerquist
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, With Applicator | QCZ | Class 3 | Unknown | No | 2018-10-23 |
| Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, For Stable Vitiligo, With Applicator | QWY | Class 3 | Unknown | No | 2023-06-29 |
Proprietary Names
RECELL
RECELL GO mini
RECELL GO
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198