Oniris
FranceFDA applicant, unverified FDA FEI 3013548547
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Oniris makes
Oniris manufactures single-use, closed-system devices designed for the preparation and administration of intravenous medications, including chemotherapy and parenteral nutrition. The Oniris and Oniris Plus systems are automated, sterile workstations that integrate compounding, mixing, and dispensing functions to enhance safety and reduce contamination risks in clinical settings.
These devices are classified under Class I and Class II regulations in the EU and the FDA’s 510(k) pathway in the US, ensuring compliance with stringent safety and performance standards. They are registered in the EU’s EUDAMED database and the FDA’s 510(k) clearance registry, reflecting their authorised status in both markets. The manufacturer operates from France.
Catalogue
Oniris; Oniris Plus Ref K250353
Regimes: CE MDR 510(k) Registry: EUDAMED510(k)
Company details
- FDA FEI number
- 3013548547
- Address
- 147 avenue Paul Doumer, RUEIL MALMAISON Hauts-de-Seine
FDA establishments
- Sas Oniris FR
Frequently asked questions
How many devices does Oniris have in the registry?
The registry currently lists 1 device for Oniris. Devices recorded under merged duplicate company entries are counted once.
Which registries list Oniris's devices?
Among its 1 most recently registered device, Oniris has devices listed in EUDAMED (1 device) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Oniris's devices fall under?
Among its 1 most recently registered device, the classes recorded for Oniris's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Oniris in the registry?
The most recently registered devices listed for Oniris include Oniris; Oniris Plus.
Which FDA establishments are linked to Oniris?
1 FDA establishment is linked to Oniris in the registry; they are listed on the company page.