FDA Registration
Active
🇺🇸 United States
Gentherm Medical, LLC
Reg #: 1516825
·
FEI: 1516825
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Gentherm Medical, LLC
- Registration Number
- 1516825
- FEI Number
- 1516825
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 12011 MOSTELLER RD
- City
- Cincinnati
- State
- OH
- ZIP
- 45241
- Country
- US
Regulatory Submissions
- 510(k) Number
- K123946
Owner / Operator
- Firm Name
- Gentherm Medical LLC
- Operator Number
- 1516825
- Address
- 12011 MOSTELLER RD.
- City
- Cincinnati
- State
- OH
- Postal Code
- 45241
- Country
- US
- Correspondent
- JONATHAN KOVACH
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Thermal Regulating | DWJ | Class 2 | Cardiovascular | No | 2013-04-04 |
Establishment Types
Manufacture Medical Device