Bioniks
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000044597 FEI 3015542970
Bioniks is a medical device manufacturer based in the United States, with 2 devices listed in FDA GUDID and EUDAMED (EU Class I; FDA Class I) as of 15 Nov 2026.
- Devices
- 2
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 2
- EUDAMED 1
- Device classes
- EU Class I 1
- FDA Class I 1
- Top EMDN categories
- Sites and related companies
- CMC Medical Devices & Drugs SL authorised representative
- Identifiers
- EUDAMED SRN US-MF-000044597
- FDA FEI 3015542970
- DUNS 078436734
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
- Authorised rep.
- CMC Medical Devices & Drugs SLES
What Bioniks makes
Bioniks makes the Kinetigram device.
The Kinetigram is a Class I medical device listed in Eudamed, and Bioniks is based in the United States.
Catalogue
- Registry: GUDID
Kinetigram Ref 200-00201
Regimes: CE MDR Registry: EUDAMEDGUDID
Company details
- EUDAMED SRN
- US-MF-000044597
- FDA FEI number
- 3015542970
- DUNS number
- 078436734
- EUDAMED status
- Active
- EUDAMED registered name
- Bioniks
- Registered address
- 2156, Central Avenue, 94501, Alameda, United States
- Lcheng@bioniks.net
- Phone
- 5107471947
- PRRC contact
- Grace Bartoo
Frequently asked questions
How many devices does Bioniks have in the registry?
The registry currently lists 2 devices for Bioniks. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bioniks's devices?
Among its 2 most recently registered devices, Bioniks has devices listed in EUDAMED (1 device) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Bioniks's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Bioniks's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Bioniks in the registry?
The most recently registered devices listed for Bioniks include Kinetigram v3 and Kinetigram.