FDA Registration
Active
🇮🇹 Italy
CER-S
Reg #: 3017840980
·
FEI: 3017840980
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CARDIOCALM SRL
- Registration Number
- 3017840980
- FEI Number
- 3017840980
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Via Martiri della Liberta 40
- City
- Montichiari Brescia
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K213861
Owner / Operator
- Firm Name
- CardioCalm Srl
- Operator Number
- 10078909
- Address
- Via Martiri della Liberta 40
- City
- Montichiari
- State
- Brescia
- Postal Code
- 25018
- Country
- IT
- Correspondent
- Fabio Badilini
US Agent
- Business Name
- Dawa Medical LLC
- Contact Name
- Stephan Toupin
- Address
- 7320 Nw 12th St Ste 103
- City
- Miami
- State
- FL
- ZIP
- 33126
- Country
- US
- [email protected]
- Phone
- 305 5999373
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2022-05-24 |
Proprietary Names
CER-S
Establishment Types
Manufacture Medical Device