FDA Registration
Active
🇮🇹 Italy
THD REVOLUTION US
Reg #: 3006680097
·
FEI: 3006680097
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- THD SPA
- Registration Number
- 3006680097
- FEI Number
- 3006680097
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Via per Carpi, 15/B
- City
- Correggio Reggio Emilia
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K141657
Owner / Operator
- Firm Name
- THD SpA
- Operator Number
- 10025818
- Address
- Via per Carpi, 15/B
- City
- Correggio
- State
- Reggio Emilia
- Postal Code
- 42015
- Country
- IT
- Correspondent
- Filippo Bastia
US Agent
- Business Name
- THD America Inc.
- Contact Name
- Filippo bastia
- Address
- 1731 SE Oralabor Road
- City
- Ankeny
- State
- IA
- ZIP
- 50021
- Country
- US
- [email protected]
- Phone
- 866 3749442
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Monitor, Ultrasonic, Nonfetal | JAF | Class 2 | Radiology | No | 2015-05-13 |
Proprietary Names
THD REVOLUTION US
THD REVOLUTION
THD REVOLUTION ACCESSORIES PACK US
THD OPTI-FIBER (REVO/BT)
Establishment Types
Manufacture Medical Device