FDA Registration
Active
🇫🇷 France
MAC 2000 ECG ANALYSIS SYSTEM
Reg #: 3007184699
·
FEI: 3007184699
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Cardiabase
- Registration Number
- 3007184699
- FEI Number
- 3007184699
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 84 avenue du XXeme Corps
- City
- Nancy Meurthe-et-Moselle
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K133622
Owner / Operator
- Firm Name
- Cardiabase
- Operator Number
- 10029804
- Address
- 84 avenue du XXeme Corps
- City
- Nancy
- State
- Meurthe-et-Moselle
- Postal Code
- 54000
- Country
- FR
US Agent
- Business Name
- PRAMEX
- Contact Name
- FERRY Nicolas
- Address
- 1251 Avenue of the Americas,, 3RD FI
- City
- New York
- State
- NY
- ZIP
- 10020
- Country
- US
- [email protected]
- Phone
- 212 8725019 ext. 1
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | Class 2 | Cardiovascular | No | 2022-11-15 |
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2022-11-15 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2022-11-15 |
Proprietary Names
MAC 2000 ECG ANALYSIS SYSTEM
Establishment Types
Foreign Private Label Distributor