FDA Registration
Active
🇮🇹 Italy
Digistat Smart Central
Reg #: 3015173634
·
FEI: 3015173634
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ASCOM UMS SRL
- Registration Number
- 3015173634
- FEI Number
- 3015173634
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Via Amilcare Ponchielli 29
- City
- Scandicci Firenze
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K180430
Owner / Operator
- Firm Name
- Ascom UMS srl
- Operator Number
- 10059298
- Address
- Via Amilcare Ponchielli 29
- City
- Scandicci
- State
- Firenze
- Postal Code
- 50018
- Country
- IT
US Agent
- Business Name
- Regulatory Insight, Inc.
- Contact Name
- Kevin Walls
- Address
- 33 Golden Eagle Lane
- City
- Littleton
- State
- CO
- ZIP
- 80127
- Country
- US
- [email protected]
- Phone
- 720 9625412
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Network And Communication, Physiological Monitors | MSX | Class 2 | Cardiovascular | No | 2018-12-19 |
Proprietary Names
Digistat Smart Central
Establishment Types
Manufacture Medical Device