FDA Registration
Active
🇫🇷 France
Cardiabase
Reg #: 3007184699
·
FEI: 3007184699
·
Expires 2026
Products
11
Proprietary Names
20
Establishment Types
1
Classifications
10
Registration Details
- Registration Name
- Cardiabase
- Registration Number
- 3007184699
- FEI Number
- 3007184699
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 84 avenue du XXeme Corps
- City
- Nancy Meurthe-et-Moselle
- Country
- FR
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 |
|---|---|---|---|---|---|
| Electrocardiograph Software For Over-The-Counter Use | QDA | Class 2 | Cardiovascular | No | 2023-12-04 |
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | Class 2 | Cardiovascular | No | 2023-12-04 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2023-12-04 |
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2022-11-15 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2022-11-15 |
| Electrode, Electrocardiograph, Multi-Function | MLN | Class 2 | Cardiovascular | No | 2018-02-07 |
| LOS | No | 2009-07-02 | |||
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2022-11-15 |
| Electrocardiograph, Ambulatory (Without Analysis) | MWJ | Class 2 | Cardiovascular | No | 2023-12-04 |
| Electrocardiograph, Ambulatory, With Analysis Algorithm | MLO | Class 2 | Cardiovascular | No | 2023-12-04 |
| Recorder, Magnetic Tape, Medical | DSH | Class 2 | Cardiovascular | No | 2010-04-22 |
Proprietary Names
KARDIA
MAC 5500 HD, MAC 3500
MAC 800 RESTING ECG ANALYSIS SYSTEM
SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM
MAC 2000 ECG ANALYSIS SYSTEM
SPACELABS 90217A
ELECTRODES
CARDIOVIT FT1
ELI 250 C
ELI 250 RX
AMBU disposable ECG electrodes
ELI 150 RX
ELI 150 C
MAC 5000 ECG ANALYSIS SYSTEM
OBPM
CARDIOMEM CM3000
H12+ HOLTER RECORDER
SPIDERVIEW
SEER 12
CARDIOMEM CM3000-12BT
Establishment Types
Foreign Private Label Distributor