# Bioniks

> Medical device manufacturer record on deviCERTS, compiled from public registries. 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.

- Canonical page: <https://devicerts.com/manufacturers/bioniks>
- Country: United States (from SRN)
- EUDAMED actor status: active
- Role: Manufacturer
- Registrations: EUDAMED, FDA
- EUDAMED SRN: US-MF-000044597
- FDA FEI: 3015542970
- DUNS: 078436734

## Figures

- Devices: 2
- FDA recalls (matched to the firm by name): 0

## Registry facts

*Every device of the manufacturer. A device listed in two registries counts in both.*

- Registries: FDA GUDID 2, EUDAMED 1
- Device classes: EU Class I 1, FDA Class I 1
- EMDN [V92 Medical device software - not included in other classes](https://devicerts.com/categories/emdn/V92): 1 devices

## Sites and related companies

- Authorised representative: [CMC Medical Devices & Drugs SL](https://devicerts.com/representatives/cmc-medical-devices-drugs-sl-es-ar-000000293) (Spain)

## Devices

The first 2 of 2, in the order of the canonical page, which lists them all.

- [Kinetigram v3](https://devicerts.com/devices/kinetigram-v3-200-00201-do-01) · Class I · GUDID · status: Listed
- [Kinetigram](https://devicerts.com/devices/kinetigram-200-00201) · ref 200-00201 · Class I · EUDAMED, GUDID · status: Active

## Source and citation

- Cite as: Bioniks. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/bioniks (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID](https://accessgudid.nlm.nih.gov/), [FDA registration and listing](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm)
- EUDAMED record synced: 2026-11-07
- FDA recall data as of: 2026-11-01
- Data as of: 2026-11-15
- JSON: <https://devicerts.com/manufacturers/bioniks.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/manufacturers/bioniks
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.