FDA Registration
Active
🇺🇸 United States
Veloxion
Reg #: 3028977843
·
FEI: 3028977843
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
3
Classifications
3
Registration Details
- Registration Name
- AULEA MEDICAL, INC.
- Registration Number
- 3028977843
- FEI Number
- 3028977843
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5627 Stoneridge Dr Ste 312
- City
- Pleasanton
- State
- CA
- ZIP
- 94588
- Country
- US
Regulatory Submissions
- 510(k) Number
- K191341
Owner / Operator
- Firm Name
- Aulea Medical, Inc.
- Operator Number
- 10088655
- Address
- 5627 Stoneridge Dr., Suite 312
- City
- Pleasanton
- State
- CA
- Postal Code
- 94588
- Country
- US
- Correspondent
- George Hsu
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Evacuator, Gastro-Urology | KQT | Class 2 | Gastroenterology, Urology | No | 2023-09-18 |
| Resectoscope | FJL | Class 2 | Gastroenterology, Urology | No | 2023-09-18 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2023-09-18 |
Proprietary Names
Veloxion
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility