FDA Registration
Active
🇺🇸 United States
NUANCE MEDICAL, LLC
Reg #: 3010543854
·
FEI: 3010543854
·
Expires 2026
Products
6
Proprietary Names
7
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- NUANCE MEDICAL, LLC
- Registration Number
- 3010543854
- FEI Number
- 3010543854
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5931 Sea Lion Place, Suite 113
- City
- Carlsbad
- State
- CA
- ZIP
- 92010
- Country
- US
Regulatory Submissions
- 510(k) Number
- K232674
Owner / Operator
- Firm Name
- Nuance Medical, LLC
- Operator Number
- 10045112
- Address
- 5931 Sea Lion Place, Suite 113
- City
- Carlsbad
- State
- CA
- Postal Code
- 92010
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Vapocoolant Device | MLY | Class U | Unknown | No | 2025-12-10 |
| Spill Kit | PXG | Class 1 | General Hospital | No | 2024-04-03 |
| Syringe, Ent | KCP | Class 1 | Ear, Nose, Throat | No | 2017-07-21 |
| Basin, Emesis | FNY | Class 1 | General Hospital | No | 2017-07-21 |
| Unit, Cryosurgical, Accessories | GEH | Class 2 | General, Plastic Surgery | No | 2016-08-04 |
| Collector, Ostomy | EXB | Class 1 | Gastroenterology, Urology | No | 2024-02-05 |
Proprietary Names
Pain Freeze II
Hurri-Freeze
Spill Kits
Ear Wash System
Ear Wash Basin
Easentials Adhesive Remover Spray
Easentials Skin Barrier Spray
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device