CSafe LLC
Active in EUDAMEDUnited Statesfrom SRN EUDAMED SRN US-MF-000035985
- Devices
- 1
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
- Authorised rep.
- Emergo Europe B.V.NL
What CSafe LLC makes
CSafe LLC manufactures the AX56L, a medical device designed for patient safety monitoring and fall risk assessment in healthcare environments. This device integrates with hospital systems to track patient movement and alert caregivers to potential hazards, such as falls or wandering. It is intended for use in acute care settings, including hospitals and rehabilitation centers, to enhance patient security and operational efficiency.
The AX56L is classified as a Class IIa device under EU regulations and is listed in the eudamed database. While the device is authorised for distribution within the European Economic Area, its regulatory status may vary by jurisdiction. CSafe LLC is based in the United States.
Catalogue
AX56L Ref HMC-MIL-3
Regimes: CE MDR Registry: EUDAMED
Company details
- EUDAMED SRN
- US-MF-000035985
- EU VAT number
- NL826298126B01
- EUDAMED status
- Active
- EUDAMED registered name
- CSafe LLC
- EUDAMED abbreviated name
- CSafe
- Registered address
- 675, Gateway Blvd, 45050, Monroe, United States
- Website
- csafeglobal.com/
- linkedin.com/company/csafeglobal
- [email protected]
- PRRC contact
- Scott Seybold
From the company website
CSafe's global cold chain shipping solutions ensures life-enhancing pharmaceuticals reach patients since 1979.
Frequently asked questions
How many devices does CSafe LLC have in the registry?
The registry currently lists 1 device for CSafe LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list CSafe LLC's devices?
Among its 1 most recently registered device, CSafe LLC has devices listed in EUDAMED (1 device).
What risk classes do CSafe LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for CSafe LLC's devices are Class IIa. Each device page shows its own class and authorisation.
What are the newest devices from CSafe LLC in the registry?
The most recently registered devices listed for CSafe LLC include AX56L.