Pulsion Medical Systems Se
Active in EUDAMEDGermanyfrom SRN EUDAMED FDA SRN DE-MF-000011120 FEI 3003263092
- Devices
- 5
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
What Pulsion Medical Systems Se makes
PULSION MEDICAL SYSTEMS SE manufactures hemodynamic monitoring devices, including the PulsioFlex Monitoring System, PiCCO Catheter, and Pulsiocare, which are used for patient monitoring and care.
The company's portfolio includes Class II and Class IIb devices listed in the eudamed and fda_510k registries, and is based in Germany.
Catalogue
PulsioFlex Monitoring System Ref K172259
Regimes: 510(k) Registry: 510(k)PiCCO Catheter Ref K171620
Regimes: 510(k) Registry: 510(k)PulsioFlex Monitoring System with ProAQT Sensor Ref K192169
Regimes: 510(k) Registry: 510(k)Pulsioflex Monitoring System With Picco Module Ref K122121
Regimes: 510(k) Registry: 510(k)Pulsiocare Ref 6891100
Regimes: CE MDR, withdrawn Registry: EUDAMED
Company details
- EUDAMED SRN
- DE-MF-000011120
- FDA FEI number
- 3003263092
- EU VAT number
- DE204234444
- EUDAMED status
- Active
- EUDAMED registered name
- PULSION Medical Systems SE
- Registered address
- 17, Hans-Riedl-Straße, 85622, Feldkirchen, Germany
- Website
- www.getinge.com
- [email protected]
- Phone
- +49894599140
- PRRC contact
- Nicole Kammermaier
Frequently asked questions
How many devices does PULSION MEDICAL SYSTEMS SE have in the registry?
The registry currently lists 5 devices for PULSION MEDICAL SYSTEMS SE. Devices recorded under merged duplicate company entries are counted once.
Which registries list PULSION MEDICAL SYSTEMS SE's devices?
Among its 5 most recently registered devices, PULSION MEDICAL SYSTEMS SE has devices listed in EUDAMED (1 device) and FDA 510(k) (4 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do PULSION MEDICAL SYSTEMS SE's devices fall under?
Among its 5 most recently registered devices, the classes recorded for PULSION MEDICAL SYSTEMS SE's devices are Class IIb and Class II. Each device page shows its own class and authorisation.
What are the newest devices from PULSION MEDICAL SYSTEMS SE in the registry?
The most recently registered devices listed for PULSION MEDICAL SYSTEMS SE include PulsioFlex Monitoring System, PiCCO Catheter, PulsioFlex Monitoring System with ProAQT Sensor and PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE.