FDA Registration
Active
🇮🇹 Italy
THD PRESSPROBE (ENV 50)
Reg #: 3006680097
·
FEI: 3006680097
·
Expires 2025
Products
1
Proprietary Names
23
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
- K180135
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, Esophageal Motility, Anorectal Motility, And Tube | KLA | Class 2 | Gastroenterology, Urology | No | 2018-03-14 |
Proprietary Names
THD PRESSPROBE (ENV 50)
THD PRESSKIT (FL ENV 50)
THD PRESSKIT (FL ENV 100)
THD SENSYPROBE
THD PRESSPROBE (BOX 10)
THD PRESSKIT (TR ENV 100)
THD PRESSKIT (TR ENV 50)
THD PRESSKIT (TR ENV)
THD PRESSKIT (FL BOX)
THD PRESSPROBE (BOX)
THD ANOPRESS
THD PRESSKIT (TR BOX)
THD DIGITAL MOBILE MANOMETRY
THD PRESSPROBE (ENV 200)
THD PRESSPROBE (ENV 100)
THD PRESSKIT (FL BOX 10)
THD PRESSKIT (FL ENV)
THD PRESSPROBE (ENV)
THD DIGITAL MOBILE ADVANCED
THD PRESSKIT (TR BOX 10)
THD SENSYPROBE ACCESSORY
THD PRESSKIT (TR ENV 200)
THD PRESSKIT (FL ENV 200)
Establishment Types
Manufacture Medical Device