Soterix Medical, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000012130 FEI 3012182497
- Devices
- 12
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
Catalogue
Search and filter all 12 devicesCompany details
- EUDAMED SRN
- US-MF-000012130
- FDA FEI number
- 3012182497
- EUDAMED status
- Active
- EUDAMED registered name
- Soterix Medical Inc.
- Registered address
- 1480, US Highway 9 North, 07095, Woodbridge, United States
- [email protected]
- PRRC contact
- Gokce Polack
Frequently asked questions
How many devices does SOTERIX MEDICAL,INC. have in the registry?
The registry currently lists 12 devices for SOTERIX MEDICAL,INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list SOTERIX MEDICAL,INC.'s devices?
Among its 12 most recently registered devices, SOTERIX MEDICAL,INC. has devices listed in EUDAMED (6 devices) and FDA 510(k) (6 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do SOTERIX MEDICAL,INC.'s devices fall under?
Among its 12 most recently registered devices, the classes recorded for SOTERIX MEDICAL,INC.'s devices are Class I, Class IIa and Class II. Each device page shows its own class and authorisation.
What are the newest devices from SOTERIX MEDICAL,INC. in the registry?
The most recently registered devices listed for SOTERIX MEDICAL,INC. include 1X1 tDCS mini-CT - Limited Total Energy, 1X1 tES: 1X1 Low Intensity tES Stimulator, 1X1 tDCS:1X1 Low Intensity transcranial DC Stimulator and 1X1 mini-CT tES - Limited Total Energy.