FDA Registration
Active
🇩🇪 Germany
TECOtherm NEO
Reg #: 3016507522
·
FEI: 3016507522
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- TEC COM MEDIZINTECHNIK GMBH
- Registration Number
- 3016507522
- FEI Number
- 3016507522
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Am Kruemmling 1
- City
- Kabelsketal Saxony-Anhalt
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K140078
Owner / Operator
- Firm Name
- Tec Com Medizintechnik GmbH
- Operator Number
- 10061013
- Address
- Am Kruemmling 1
- City
- Kabelsketal
- State
- Saxony-Anhalt
- Postal Code
- 06184
- Country
- DE
- Correspondent
- Sebastian Dr. Ebert
US Agent
- Business Name
- International Biomedical
- Contact Name
- Amy Piper
- Address
- 8206 Cross Park Dr
- City
- Austin
- State
- TX
- ZIP
- 78754
- Country
- US
- [email protected]
- Phone
- 512 8730033
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Thermal Regulating | DWJ | Class 2 | Cardiovascular | No | 2023-11-20 |
Proprietary Names
TECOtherm NEO
Establishment Types
Manufacture Medical Device