FDA Registration
Active
🇺🇸 United States
SUREAX MEDICAL, CORPORATION
Reg #: 3024682301
·
FEI: 3024682301
·
Expires 2026
Products
3
Proprietary Names
5
Establishment Types
5
Classifications
3
Registration Details
- Registration Name
- SUREAX MEDICAL, CORPORATION
- Registration Number
- 3024682301
- FEI Number
- 3024682301
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 11107 Roselle St 237
- City
- San Diego
- State
- CA
- ZIP
- 92121
- Country
- US
Regulatory Submissions
- 510(k) Number
- K250203
Owner / Operator
- Firm Name
- SureAx Medical, Corporation
- Operator Number
- 10086251
- Address
- 11107 Roselle St 237
- City
- San Diego
- State
- CA
- Postal Code
- 92121
- Country
- US
- Correspondent
- Ricardo Villanueva
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2023-08-24 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2026-05-01 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2026-01-06 |
Proprietary Names
LNX Needle
IMX Needle
Hook
SureAx Curve/Guide Convenience Kit
SureAx Guide
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Reprocess Single-Use Device