FDA Registration
Active
🇮🇹 Italy
EMPATICA S.r.l.
Reg #: 3012933969
·
FEI: 3012933969
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- EMPATICA S.r.l.
- Registration Number
- 3012933969
- FEI Number
- 3012933969
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Via Enrico Stendhal 36
- City
- Milano
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K181861
Owner / Operator
- Firm Name
- Empatica
- Operator Number
- 10058838
- Address
- Via Stendhal 36
- City
- Milan
- State
- Lombardy
- Postal Code
- 20144
- Country
- IT
- Correspondent
- Alberto Poli
US Agent
- Business Name
- Empatica Inc
- Contact Name
- Matteo Lai
- Address
- 1 Broadway
- City
- Cambridge
- State
- MA
- ZIP
- 02142
- Country
- US
- [email protected]
- Phone
- 415 5483860
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Physiological Signal Based Seizure Monitoring System | POS | Class 2 | Neurology | No | 2018-12-21 |
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility