FDA Registration
Active
🇺🇸 United States
URAMIX HugeMed Single-use Ureteroscope
Reg #: 2531475
·
FEI: 3001642379
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- URAMIX, INC.
- Registration Number
- 2531475
- FEI Number
- 3001642379
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 272 N. LANSDOWNE AVE.
- City
- E Lansdowne
- State
- PA
- ZIP
- 19050
- Country
- US
Regulatory Submissions
- 510(k) Number
- K240374
Owner / Operator
- Firm Name
- URAMIX, INC.
- Operator Number
- 9032397
- Address
- 272 N. LANSDOWNE AVE., --
- City
- Lansdowne
- State
- PA
- Postal Code
- 19050
- Country
- US
- Correspondent
- MICHAEL - MOOREVILLE, MD
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ureteroscope And Accessories, Flexible/Rigid | FGB | Class 2 | Gastroenterology, Urology | No | 2024-11-26 |
Proprietary Names
URAMIX HugeMed Single-use Ureteroscope
Establishment Types
Repack or Relabel Medical Device