Helios Biomedical Inc.
United Statesfrom the FDA registration address FDA establishment FEI 3025316685
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
Catalogue
DeviceDevice · Authorizations Verified Status Regime Registry Class
Helios Dermal Scaffold Ref K250397
Regimes: 510(k) Registry: 510(k)Helios Dura Regeneration Matrix Ref K250420
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3025316685
- Address
- 8 Mercer Rd, Natick, MA, 01760
Frequently asked questions
How many devices does HELIOS BIOMEDICAL INC. have in the registry?
The registry currently lists 2 devices for HELIOS BIOMEDICAL INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list HELIOS BIOMEDICAL INC.'s devices?
Among its 2 most recently registered devices, HELIOS BIOMEDICAL INC. has devices listed in FDA 510(k) (2 devices).
What risk classes do HELIOS BIOMEDICAL INC.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for HELIOS BIOMEDICAL INC.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from HELIOS BIOMEDICAL INC. in the registry?
The most recently registered devices listed for HELIOS BIOMEDICAL INC. include Helios Dermal Scaffold and Helios Dura Regeneration Matrix.