FDA Registration
Active
🇨🇳 China
IOB Warming Blankets
Reg #: 3010168054
·
FEI: 3010168054
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Jiangmen Dacheng Medical Equipment Co., Ltd.
- Registration Number
- 3010168054
- FEI Number
- 3010168054
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- #8 South of Jiaobei Hengkeng, Jianghai District
- City
- Jiangmen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K221669
Owner / Operator
- Firm Name
- Gentherm Medical LLC
- Operator Number
- 10042384
- Address
- 12011 Mosteller Road
- City
- Cincinnati
- State
- OH
- Postal Code
- 45241
- Country
- US
- Correspondent
- Jonathan Kovach
US Agent
- Business Name
- Gentherm Medical LLC
- Contact Name
- Jonathan Kovach
- Address
- 12011 Mosteller Road
- City
- Cincinnati
- State
- OH
- ZIP
- 45241
- Country
- US
- [email protected]
- Phone
- 513 3265295
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Thermal Regulating | DWJ | Class 2 | Cardiovascular | No | 2023-01-22 |
Proprietary Names
IOB Warming Blankets
Establishment Types
Manufacture Medical Device