FDA Registration
Active
🇮🇹 Italy
THD PROCTOSTATION
Reg #: 3006680097
·
FEI: 3006680097
·
Expires 2025
Products
5
Proprietary Names
10
Establishment Types
1
Classifications
5
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
- K211623
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 |
|---|---|---|---|---|---|
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2021-07-09 |
| Camera, Television, Endoscopic, With Audio | FWG | Class 1 | General, Plastic Surgery | No | 2021-07-09 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2021-07-09 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2021-07-09 |
| Monitor, Esophageal Motility, Anorectal Motility, And Tube | KLA | Class 2 | Gastroenterology, Urology | No | 2021-07-09 |
Proprietary Names
THD PROCTOSTATION
THD PROCTOMOBILE
THD DIGITAL MOBILE ECOGRAPHY
THD DIGITAL MOBILE
THD DIGITAL MOBILE ADVANCED
THD DIGITAL MOBILE LIGHT
THD DIGITAL MOBILE MANOMETRY
THD HRSTATION
THD PROCTO SOFTWARE
THD 4K CAM
Establishment Types
Manufacture Medical Device