FDA Registration
Active
🇩🇪 Germany
Sensis Vibe Hemo (VD15B)
Reg #: 3004977335
·
FEI: 3004977335
·
Expires 2025
Products
9
Proprietary Names
2
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- Siemens Healthineers AG
- Registration Number
- 3004977335
- FEI Number
- 3004977335
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- SIEMENSSTRASSE 1 -OR-, Rittigfeld 1
- City
- FORCHHEIM Bavaria
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K223812
Owner / Operator
- Firm Name
- Siemens Healthineers AG
- Operator Number
- 8010024
- Address
- Karlheinz-Kaske-Str. 5, --
- City
- Erlangen
- State
- DE-NOTA
- Postal Code
- 91052
- Country
- DE
US Agent
- Business Name
- SIEMENS MEDICAL SOLUTIONS USA, INC.
- Contact Name
- Robert Phillips
- Address
- 40 Liberty Boulevard
- City
- MALVERN
- State
- PA
- ZIP
- 19355
- Country
- US
- [email protected]
- Phone
- 302 2359839
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2023-09-20 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2023-09-20 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2023-09-20 |
| Amplifier And Signal Conditioner, Transducer Signal | DRQ | Class 2 | Cardiovascular | No | 2023-09-20 |
| Probe, Thermodilution | KRB | Class 2 | Cardiovascular | No | 2023-09-20 |
| Alarm, Blood-Pressure | DSJ | Class 2 | Cardiovascular | No | 2023-09-20 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2023-09-20 |
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2023-09-20 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2023-09-20 |
Proprietary Names
Sensis Vibe Hemo (VD15B)
Sensis Vibe Combo (VD15B)
Establishment Types
Manufacture Medical Device