Neodyne Biosciences, Inc.
Active in EUDAMEDUnited Statesfrom EUDAMED address EUDAMED FDA SRN US-MF-000056898 FEI 3009192857
- Devices
- 1
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
What Neodyne Biosciences, Inc. makes
Neodyne Biosciences, Inc. manufactures medical-grade silicone dressings designed for scar management, including hydration-based treatments to help flatten, soften, and reduce scar visibility.
The company’s products fall under FDA Class I devices and are listed via the 510(k) pathway. Neodyne Biosciences, Inc. is based in the United States.
Catalogue
Neodyne Dressing Ref K112131
Regimes: 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- US-MF-000056898
- FDA FEI number
- 3009192857
- EUDAMED status
- Active
- EUDAMED registered name
- Neodyne Biosciences, Inc.
- EUDAMED abbreviated name
- Neodyne
- Address
- 47801 Fremont Blvd., Fremont, CA, 94538
- Website
- embracescartherapy.com
- facebook.com/embracescartherapy
- [email protected]
- Phone
- 1.855.722.7879
- PRRC contact
- Jasper Jackson
From the company website
embrace® medical-grade silicone therapy is clinically proven to help flatten, soften, and fade scars by hydrating scar tissue for a beautiful finish. Shop now.
Frequently asked questions
How many devices does Neodyne Biosciences, Inc. have in the registry?
The registry currently lists 1 device for Neodyne Biosciences, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Neodyne Biosciences, Inc.'s devices?
Among its 1 most recently registered device, Neodyne Biosciences, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Neodyne Biosciences, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Neodyne Biosciences, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Neodyne Biosciences, Inc. in the registry?
The most recently registered devices listed for Neodyne Biosciences, Inc. include NEODYNE DRESSING.