Bionix, LLC
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000020408 FEI 1526854
Bionix, LLC is a medical device manufacturer based in the United States, with 220 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class I and II; EU Class I) as of 15 Nov 2026.
- Devices
- 220
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 218
- EUDAMED 67
- FDA 510(k) 2
- Device classes
- FDA Class I 96
- FDA Class II 65
- EU Class I 59
- Top EMDN categories
- Sites and related companies
- Obelis S.A. authorised representative
- Identifiers
- EUDAMED SRN US-MF-000020408
- FDA FEI 1526854
- DUNS 117844489
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
- Authorised rep.
- Obelis S.A.BE
What Bionix, LLC makes
Bionix, LLC manufactures radiological whole-body positioners, ENT illuminating foreign body extraction sets, dermal tattoo ink, and reusable ear canal irrigation kits. The company also produces ear canal lavage systems, enteral feeding tube clearing kits, assistive drinking straws, and reusable device sterilization or disinfection containers.
The company is based in the United States and maintains a portfolio of Class I and Class II medical devices. These products are listed in the FDA UDI database and EUDAMED.
Catalogue
Search and filter all 220 devicesShowing 1-50 of 220
Company details
- EUDAMED SRN
- US-MF-000020408
- FDA FEI number
- 1526854
- DUNS number
- 117844489
- EUDAMED status
- Active
- EUDAMED registered name
- Bionix LLC
- Registered address
- 1670, Indian Wood Circle, 43537, Maumee, United States
- Website
- www.bionix.com
- bionix@bionix.com
- Phone
- +1 419 214 6050
- PRRC contact
- Joshua Ball
Frequently asked questions
How many devices does Bionix, LLC have in the registry?
The registry currently lists 220 devices for Bionix, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bionix, LLC's devices?
Among its 50 most recently registered devices, Bionix, LLC has devices listed in EUDAMED (5 devices) and FDA GUDID (50 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Bionix, LLC's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Bionix, LLC's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bionix, LLC in the registry?
The most recently registered devices listed for Bionix, LLC include Microsuction Replacement Pack 2651, Lighted Magnetic Foreign Body Removal Tool 3525, Rechargeable Light Source 3600 and ClearLook Variety Pack with Rechargeable Light Source 3645.