FDA Registration
Active
🇺🇸 United States
Monarch Platform, Urology
Reg #: 3017425975
·
FEI: 3017425975
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Auris Health, Inc
- Registration Number
- 3017425975
- FEI Number
- 3017425975
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5490 Great America Pkwy
- City
- Santa Clara
- State
- CA
- ZIP
- 95054
- Country
- US
Regulatory Submissions
- 510(k) Number
- K213334
Owner / Operator
- Firm Name
- Auris Health, Inc.
- Operator Number
- 10057462
- Address
- 5490 Great America Parkway
- City
- Santa Clara
- State
- CA
- Postal Code
- 95054
- Country
- US
- Correspondent
- Joy Sacmar
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Irrigation, Urological | LJH | Class 2 | Gastroenterology, Urology | No | 2022-05-25 |
| Needle, Catheter | GCB | Class 1 | General, Plastic Surgery | No | 2022-05-25 |
| Kit, Nephroscope | FGA | Class 2 | Gastroenterology, Urology | No | 2022-05-25 |
| Catheter, Nephrostomy | LJE | Class U | Unknown | No | 2022-05-25 |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | Class 2 | Gastroenterology, Urology | No | 2022-05-25 |
Proprietary Names
Monarch Platform, Urology
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility