FDA Registration
Active
🇺🇸 United States
Celsi Warmer
Reg #: 3030597679
·
FEI: 3030597679
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- HADLEIGH HEALTH TECHNOLOGIES
- Registration Number
- 3030597679
- FEI Number
- 3030597679
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 200 Gate 5 Road, Suite 215
- City
- Sausalito
- State
- CA
- ZIP
- 94965
- Country
- US
Regulatory Submissions
- 510(k) Number
- K242964
Owner / Operator
- Firm Name
- Hadleigh Health Technologies
- Operator Number
- 10090336
- Address
- 200 Gate 5 Road, Suite 215
- City
- Sausalito
- State
- CA
- Postal Code
- 94965
- Country
- US
- Correspondent
- Margaret McCabe
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Thermal Regulating | DWJ | Class 2 | Cardiovascular | No | 2025-07-03 |
Proprietary Names
Celsi Warmer
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility