FDA Registration
Active
🇮🇱 Israel
Biobeat Platform 2
Reg #: 3015455735
·
FEI: 3015455735
·
Expires 2025
Products
6
Proprietary Names
1
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- BIOBEAT TECHNOLOGIES LTD
- Registration Number
- 3015455735
- FEI Number
- 3015455735
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 22 Efal st.
- City
- Petach Tikva Central
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K222010
Owner / Operator
- Firm Name
- Biobeat Technologies LTD
- Operator Number
- 10082659
- Address
- 22 Efal St
- City
- Petach Tikva
- State
- Central
- Postal Code
- 4951122
- Country
- IL
- Correspondent
- Johanan May
US Agent
- Business Name
- A. Stein Regulatory Affairs
- Contact Name
- Naphtali Deutsch
- Address
- 9559 COLLINS AVE, APARTMENT 1007
- City
- Surfside
- State
- FL
- ZIP
- 33154
- Country
- US
- [email protected]
- Phone
- 888 4433867
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Computer, Diagnostic, Pre-Programmed, Single-Function | DXG | Class 2 | Cardiovascular | No | 2023-10-11 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2023-10-11 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2023-10-11 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2023-10-11 |
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2023-10-11 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2023-10-11 |
Proprietary Names
Biobeat Platform 2
Establishment Types
Manufacture Medical Device